Data report

 

Logged in as: Mike Dewhirst, ABC Australia Pty Ltd

Always refresh your browser to see any changes: 2023-10-23 01:14:28 UTC

This report shows data used as input for categorisation plus generated information of possible interest to AICIS in the event of an audit.

 

Industrial chemical data

Chemical public name: Amyl ethyl ether
CAS name: tert-Amyl ethyl ether
Portfolio ID: NIC1005242
Division ABC Australia Pty Ltd - Operations
Access status Default - all identifying information (name, CAS etc) visible
Physical state Liquid
Origin Imported
Information availability Introducer does know the CAS number and CAS name for the introduced chemical
CAS number 919-94-8
AICIS listing Searched for but not found
AICIS listing: Searched for but not found 23 October 2023

AICIS listing: Searched for but not found

DISCLAIMER: Downloaded AIIC Inventory records searched were supplied by AICIS, dated 1 September 2022, and updated as since published by AICIS according to the Act.

AICIS's disclaimer includes the words ... '[Downloaded records] should not be relied on for the latest information about a chemical – you must search the online Inventory to see if your chemical is listed and what any terms of its listing are.'

See the Useful link: 'AICIS CAS number search' to satisfy their disclaimer

CAS name tert-Amyl ethyl ether
IUPAC name Not entered
INCI name Not entered
Nano-material No
Nano-soluble No
Incidental nano-material No
UVCB substance Not applicable
UVCB substance description Not applicable
GM product No
Name of GM organism Not applicable
Biological chemical No
Biochemical No
Biocidal active No
Organotin No
UV filter No
Polyhalogenated organic No
Fully fluorinated carbons No
Highly branched organic Not applicable
Persistent No
Environment info required for AICIS: 05 Persistent bioaccumulative and toxic: Log Kow 23 October 2023

A suitable in-silico prediction for partition coefficient of the chemical itself of log Kow <4.2 (that is not negated by a measured log Kow) or

a measured value from a study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for partition coefficient for which log Kow <4.2

OECD Test 107: Partition Coefficient (n-octanol/water): Shake Flask Method

(EU Annex V test methods A.8; OCSPP 830.7550; OPPT 796.1550; OPP 63-11)

OECD Test 117: Partition Coefficient (n-octanol/water), HPLC Method

(EU Annex V test methods A.8; OCSPP 830.7570; OPPT 796.1570; OPP 63-11)

OECD Test 123: Partition Coefficient (1-Octanol/Water): Slow-Stirring Method

(EU Annex V test methods A.8)

Readily biodegradable No
Bioconcentration factor 38 BCF
Bioaccumulation factor Not entered
Octanol/Water partition ratio 3.15
Aqueous solubility 3.92
CDP company Not entered
Data provider XXX
International assessment Not entered
International health assessment No
Permission to use entire health assessment report Not applicable
International environment assessment No
Permission to use entire environment assessment report Not applicable
Rotterdam-Stockholm-Minamata Not detected
Formula C₇H₁₆O
2D structure O
Chemical structure Not entered
Molecular weight 116.2 g/mol
EC No Not entered
ChemSpider ID 12939
Standard InChIKey KFRVYYGHSPLXSZ-UHFFFAOYSA-N (commonchemistry.cas.org)
KFRVYYGHSPLXSZ-UHFFFAOYSA-N (ChemSpider)
Standard InChI InChI=1S/C7H16O/c1-5-7(3,4)8-6-2/h5-6H2,1-4H3 (commonchemistry.cas.org)
InChI=1S/C7H16O/c1-5-7(3,4)8-6-2/h5-6H2,1-4H3 (ChemSpider)
SMILES structure CCC(C)(C)OCC (commonchemistry.cas.org)
CCC(C)(C)OCC (ChemSpider)

1  Chemical volume

Product name ABC Racing fuel
    End use scenario Fuel, oil and related products
    End use Gasoline or petrol
    Maximum end use concentration 10  %
    Child or food contact Neither
    Aerosolised during end use No
    Any consumer end use No
    No of items Not entered
    Item unit weight Not entered
    Product volume 560  t
    Precise proportion 10%  m/m  Amyl ethyl ether
    Chemical volume 56  t

Introduction

Report ID Not entered
Exclusion Not applicable
Specified class Not applicable
Circumstances Not applicable
Introduction category Not entered
Total introduced 56,000.0  kg
Maximum concentration 10  %
Software revision 1.11.0

5  Hazards

H305 H305 Aspiration hazard: Category 2: May be harmful if swallowed and enters airways
H315 H315 Skin corrosion/irritation: Category 2: Causes skin irritation
H319 H319 Serious eye damage/eye irritation: Category 2: Causes serious eye irritation
H336 H336 Specific target organ toxicity - single exposure: Category 3: May cause drowsiness or dizziness
IC-R.S1.2.4.13 IC-R.S1.2.4.13 Environmental pollutant: Aquatic: Industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability

7  Synonyms

.. aka .. 2-Ethoxy-2-methylbutane
.. aka .. Butane, 2-ethoxy-2-methyl-
.. aka .. Ether, ethyl tert-pentyl
.. aka .. Ethyl 1,1-dimethylpropyl ether
.. aka .. Ethyl tert-amyl ether
.. aka .. Ethyl tert-pentyl ether
.. aka .. tert-Amyl ethyl ether

19  Useful links

AICIS assessment https://services.industrialchemicals.gov.au/search-assessments/
AICIS CAS number search https://services.industrialchemicals.gov.au/search-inventory/

If the CAS number is found this link will lead to the Inventory terms of listing. Otherwise it is most likely not listed
AICIS checklist - Reported - low risk https://www.industrialchemicals.gov.au/sites/default/files/2021-03/Reported%20checklist%20-%20Highest%20indicative%20risk%20for%20your%20introduction%20is%20low%20risk%20%5B516%20KB%5D_0.pdf

The pdf file in this link will either download or display depending on your browser preferences
AICIS Google search https://www.google.com/search?q=919-94-8+site%3A.industrialchemicals.gov.au

Google search of the AICIS website for existing documents containing this CAS number
AICIS record keeping obligations - Reported - low risk https://www.industrialchemicals.gov.au/business/reporting-and-record-keeping-obligations/record-keeping-obligations-reported-introductions/record-keeping-reported-introductions-highest-indicative-risk-low-risk
Attachment 13 - Racing Fuel 200 L Label Rear Panel https://www.dropbox.com/s/vpabb599cz5w67o/Item%2028%20-%20Attachment%2013%20-%20Racing%20Fuel%20200%20L%20Label%20Rear%20Panel.pdf?dl=0
Attachment 15 - Racing Fuel 50 L Label Rear Panel https://www.dropbox.com/s/wtnvkut04pj05kn/Item%2032%20-%20Attachment%2015%20-%20Racing%20Fuel%2050%20L%20Label%20Rear%20Panel.pdf?dl=0
Attachment 17 - Racing Fuel 20 L Label Rear Panel https://www.dropbox.com/s/ejz0xrwa58irksb/Item%2036%20-%20Attachment%2017%20-%20Racing%20Fuel%2020%20L%20Label%20Rear%20Panel.pdf?dl=0
Attachment 8 - NICNAS Full Public Report on t-Amyl methyl ether (TAME) NA_878 https://www.dropbox.com/s/p4x3drp51w75pef/Item%2018%20-%20Attachment%208%20-%20NICNAS%20Full%20Public%20Report%20on%20t-Amyl%20methyl%20ether%20%28TAME%29%20NA_878%20highlighted.pdf?dl=0
Attachment 9 - European Union Risk Assessment Report, Tert-Butyl Methyl Ether, 2002 https://www.dropbox.com/s/k3l5s1xe7lrfwz4/Item%2020%20-%20Attachment%209%20-%20European%20Union%20Risk%20Assessment%20Report%2C%20Tert-Butyl%20Methyl%20Ether%2C%202002%20highlighted.pdf?dl=0
CAS Common Chemistry https://commonchemistry.cas.org/results?q=919-94-8

Use this link to find the CAS name
ChemIDplus https://chem.nlm.nih.gov/chemidplus/rn/919-94-8
ChemSpider http://www.chemspider.com/Chemical-Structure.12939.html
EC CosIng search site https://ec.europa.eu/growth/tools-databases/cosing/

You need to search after clicking the above link. Copy 919-94-8 ready to paste into the EC CosIng search field.

If you find Amyl ethyl ether, paste its URL into the Change field of Link URL above and save.

You may also need to accept the EC CosIng terms and possibly their cookies as well

ECHA information search site https://echa.europa.eu/information-on-chemicals

You need to search after clicking the above link. Copy 919-94-8 ready to paste into the ECHA information search field.

If you find Amyl ethyl ether, paste its URL into the Change field of Link URL above and save.

You may also need to accept the ECHA information terms and possibly their cookies as well

IFA GESTIS https://www.dguv.de/ifa/gestis/gestis-stoffdatenbank/index-2.jsp

We cannot link directly to substances in IFA GESTIS. But here is a workaround! Please visit ...

https://www.dguv.de/ifa/gestis/gestis-stoffdatenbank/index-2.jsp

... select your language and search for CAS 919-94-8 or Amyl ethyl ether. When you find it, copy the URL from the browser into the Change field here. Click [Save] and then test the new link. If it works, blank out this 'Synopsis'

NIST Webbook https://webbook.nist.gov/cgi/cbook.cgi?ID=919-94-8
PubChem https://pubchem.ncbi.nlm.nih.gov/compound/919-94-8
US EPA https://actor.epa.gov/actor/chemical.xhtml?casrn=919-94-8

8  Notes

Aspiration hazard (H305) opinion Dear Mike and Richard,

I refer to Mike's email below.

I attach the relevant section chapter 3.10 on Aspiration Hazard from GHS revision 9.

I have highlighted some sections regarding the classification for aspiration hazard.

For the sake of this exercise I'm focusing particularly on:

Chemical name: t-Amyl Ethyl Ether.

CAS #: 919-94-8.

As background I downloaded from the web the attached SDS which seems to suggest that the kinematic viscosity of t-Amyl Ethyl Ether is:

0.648 mm²/s @ 20°C.

0.531 mm²/s @ 40°C.

I also downloaded the attached entry from the ECHA registration dossier for t-Amyl Ethyl Ether, which shows that the GHS classification is:

Ref GHS chapter | Hazard cat | Code | Hazard statement

Flammable liquids | category 2 | H225 | Highly flammable liquid and vapour

Skin corrosion/irritation | category 2 | H315 | Causes skin irritation

Serious eye damage/irritation | category 2 | H319 | Causes serious eye irritation

Aspiration hazard | category 2 | H305 | May be harmful if swallowed and enters airways

Specific target organ toxicity - single (STOT-SE) | category 3 | H336 | May cause drowsiness or dizziness

So, going back to the GHS we can see on page 2 it states under the criteria of category 2:

On the basis of existing animal studies and expert judgment that takes into account surface tension, water solubility, boiling point, and volatility, substances, other than those classified in Category 1, which have a kinematic viscosity ≤ 14 mm2/s, measured at 40° C (see note 2).

From the above data t-Amyl Ethyl Ether appears to have a kinematic viscosity ≤ 14 mm2/s, measured at 40° C

Also note 2 on page 2 of the GHS extract states:

Taking this into account, some authorities would consider the following to be included in this Category:

n-primary alcohols with a composition of at least 3 carbon atoms but not more than 13; isobutyl alcohol, and ketones with a composition of no more than 13 carbon atoms.

t-Amyl Ethyl Ether does not appear to appear on the SafeWork Australia HCIS.

I then had a look at the SafeWork Australia HCIS entry (which I attach) for:

Chemical name: 2-methylpropan-1-ol.

Chemical synonym: isobutanol or isobutyl alcohol.

CAS #: 78-83-1.

As can be seen, SafeWork Australia HCIS do not classify isobutanol as an aspiration hazard

So, on that basis I would presume that it is a balance as to whether or not t-Amyl Ethyl Ether should be classified as:

Aspiration hazard, category 2.

Mike, at least you now have some arguments to support the classification of this example chemical in your system

Environment info required for AICIS: 06 Very toxic to any aquatic life 23 October 2023

Information on aquatic toxicity for all three trophic levels (fish, invertebrates and algae) from suitable in silico predictions on the chemical or in vivo studies on the chemical or from suitable read across information, conducted following acceptable test guidelines for aquatic toxicity, with the following results for all three trophic levels:

- acute aquatic toxicity >1 mg/L (96 h LC50 (fish), or 48 h EC50 (invertebrates) or 72 or 96 h ErC50 (algae)), or

- chronic aquatic toxicity NOEC or EC10 >0.1 mg/L (for chemicals that are not readily biodegradable)

OECD Test 201: Freshwater Alga and Cyanobacteria, Growth Inhibition Test

(EU Annex V test methods C.3; OCSPP 850.4550; OPPT 797.1050; OPP 122-2; OPP 123-2)

OECD Test 202: Daphnia sp. Acute Immobilisation Test

(ISO 6341; EU Annex V test method C. 2; OCSPP 850.1010; OPP 72-2)

OECD Test 203: Fish, Acute Toxicity Test

(ISO 10229; EU Annex V test method C.1; OCSPP 850.1075; OPP 72-1; OPP 72-3)

OECD Test 210: Fish, Early-life Stage Toxicity Test

(OCSPP 850.1400; EU Annex V test method C.15)

OECD Test 211: Daphnia magna Reproduction Test

(OCSPP 850.1300; EU Annex V test method C.20)

Health info required for AICIS: 05 Genetic toxicity: GRAS substances 23 October 2023

Information to demonstrate that the chemical is included on the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, and that the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or

Information to demonstrate that the chemical has been notified to the US FDA GRAS notification program and FDA had no questions about the notifier's conclusion of GRAS status, and that the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or

information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation or

test results that demonstrate the absence of mutagenic or genotoxic effects from both:

- study on the chemical or from suitable read across information conducted following an acceptable test guideline for gene mutation, and

- study on the chemical or from suitable read across information conducted following an acceptable test guideline for chromosomal abnormalities.

OECD Test 471: Bacterial Reverse Mutation Test

(EU Annex V test methods B.13 and B.14; OCSPP 870.5100; OPPT 798.5100; OPPT 798.5265; OPP 84-2)

OECD Test 473: In Vitro Mammalian Chromosomal Aberration Test

(EU Annex V test method B.10; OCSPP 870.5375; OPPT 798.5375; OPP 84-2)

OECD Test 474: Mammalian Erythrocyte Micronucleus Test

(EU Annex V test method B.12; OCSPP 870.5395; OPPT 798.5395; OPP 84-2)

OECD Test 475: Mammalian Bone Marrow Chromosomal Aberration Test

(EU Annex V test method B.11; OCSPP 870.5385; OPPT 798.5385; OPP 84-2)

OECD Test 476: In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes

(EU Annex V test method B.17; OCSPP 870.5300; OPPT 798.5300; OPP 84-2)

OECD Test 478: Rodent Dominant Lethal Test

(EU Annex V test method B.22; OPPT 798.5450, 870.5450)

OECD Test 485: Genetic toxicology, Mouse Heritable Translocation Assay

(EU Annex V test method B.25; OPPT 798.5460, 870.5460)

OECD Test 486: Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo

(EU Annex V test method B.39)

OECD Test 487: In Vitro Mammalian Cell Micronucleus Test

(EU Annex V test method B.49)

OECD Test 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays

(EU Annex V test method B.58)

OECD Test 489: In Vivo Mammalian Alkaline Comet Assay

OECD Test 490: In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene

Health info required for AICIS: 10 Skin corrosion 23 October 2023

Test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for skin corrosion, with a non-corrosive prediction, or

test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for skin irritation, with a non-irritant prediction, or

test results from an in vivo study on the chemical or from suitable read across information, conducted following an acceptable test guideline for skin irritation, which does not result in destruction of skin tissue, as described for skin corrosion in chapter 3.2 of the GHS.

OECD Test 404: Acute Dermal Irritation/Corrosion

(EU Annex V test method B.4.; OCSPP 870.2500; OPPT 798.4470; OPP 81-5)

OECD Test 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER)

(EU Annex V test method B.43; EURL ECVAM DB-ALM protocol No.115)

OECD Test 431: In vitro skin corrosion: reconstructed human epidermis (RHE) test method

(EU Annex V test method B.40; EURL ECVAM DB-ALM protocols No.118 and 119)

OECD Test 435: In Vitro Membrane Barrier Test Method for Skin Corrosion

(EURL ECVAM DB-ALM protocol No.116)

OECD Test 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method

(EU Annex V test method B.46; EURL ECVAM DB-ALM protocols No.131, 135 and 138)

Health info required for AICIS: 11 Eye damage 23 October 2023

Test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for eye damage, which predicts the chemical would not induce serious eye damage, or

test results from an in vivo study on the chemical or from suitable read across information, conducted following an acceptable test guideline for eye irritation, which does not result in effects on the eye, as described for eye damage in chapter 3.3 of the GHS

OECD Test 405: Acute Eye Irritation/Corrosion

(EU Annex V test methods B.5; OCSPP 870.2400; OPPT 798.4500; OPP 81-4)

OECD Test 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

(EU Annex V test method B.47; EURL ECVAM DB-ALM protocols No. 98 and 124)

OECD Test 438: Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

(EU Annex V test method B.48; EURL ECVAM DB-ALM protocol No. 80)

OECD Test 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants

(EURL ECVAM DB-ALM protocol No. 71)

OECD Test 491: Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

OECD Test 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage

OECD Test 494: Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage

Health info required for AICIS: 12 Skin sensitisation 23 October 2023

Test results from an in chemico test on the chemical or from suitable read-across information, conducted following an acceptable test guideline for the 1st key event in skin sensitisation, with a non-sensitising prediction; and

results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for the 2nd key event in skin sensitisation, with a nonsensitising prediction; and

test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for the 3rd key event in skin sensitisation, with a non-sensitising prediction. OR

Test results from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for skin sensitisation, which does not result in induction of an allergic response, as described in chapter 3.4 of the GHS.

OECD Test 406: Skin Sensitisation

(EU Annex V test method B.6; OCSPP 870.2600; OPPT 798.4100; OPP 81-6)

OECD Test 429: Skin Sensitisation

(EU Annex V test method B.42)

OECD Test 442A: Skin Sensitization

(EU Annex V test method B.50)

OECD Test 442B: Skin Sensitization

(EU Annex V test method B.51)

OECD Test 442C: In Chemico Skin Sensitisation

(EU Annex V test methods B.59; EURL ECVAM DB-ALM protocol No.154)

OECD Test 442D: In Vitro Skin Sensitisation

(EU Annex V test method B.60; EURL ECVAM DB-ALM protocol No.155)

OECD Test 442E: In Vitro Skin Sensitisation

(EURL ECVAM DB-ALM protocol No.158)

Health info required for AICIS: 13 Acute toxicity (fatal or toxic) 23 October 2023

The chemical is permitted to be used as a food additive according to Schedule 15 of the Australia New Zealand Food Standards Code - Standard 1.3.1 - Food Additives, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or

a test result from at least one in vivo study on the chemical or from suitable read across information, as detailed below, with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available):

- conducted following an acceptable test guideline for acute oral toxicity with an LD50 greater than 300 mg/kg bw, or

- conducted following an acceptable test guideline for acute dermal toxicity with an LD50 greater than 1,000 mg/kg bw, or

- conducted following an acceptable test guideline for acute inhalation toxicity, with an LC50:

- for gases - greater than 2,500 ppmV/4h, or

- for vapours - greater than 10 mg/L/4h, or

- for dusts/mists/fumes - greater than 1 mg/L/4h, or

test results from an in vivo study via the oral route on the chemical or from suitable read across information, conducted following an acceptable test guideline for subacute oral toxicity, with a NOAEL greater than or equal to 1,000 mg/kg bw/day

OECD Test 401: Acute Oral Toxicity

(EU Annex V test methods B.1, B.1 bis, B.1 tris; OCSPP 870.1100; OPPT 798.1175; OPP 81-1)

OECD Test 403: Acute Inhalation Toxicity

(EU Annex V test methods B.2 or B.52; OCSPP 870.1300; OPPT 798.1150; OPP 81-3)

OECD Test 420: Acute Oral Toxicity - Fixed Dose Procedure

(EU Annex V test methods B.1, B.1 bis, B.1 tris; OCSPP 870.1100; OPPT 798.1175; OPP 81-1)

OECD Test 423: Acute Oral toxicity - Acute Toxic Class Method

(EU Annex V test methods B.1, B.1 bis, B.1 tris; OCSPP 870.1100; OPPT 798.1175; OPP 81-1)

OECD Test 425: Acute Oral Toxicity: Up-and-Down Procedure

(EU Annex V test methods B.1, B.1 bis, B.1 tris; OCSPP 870.1100; OPPT 798.1175; OPP 81-1)

OECD Test 433: Acute Inhalation Toxicity: Fixed Concentration Procedure

(EU Annex V test methods B.2 or B.52; OCSPP 870.1300; OPPT 798.1150; OPP 81-3)

OECD Test 436: Acute Inhalation Toxicity – Acute Toxic Class Method

(EU Annex V test methods B.2 or B.52; OCSPP 870.1300; OPPT 798.1150; OPP 81-3)

Health info required for AICIS: 14 STOT after repeated exposure: > 1,000 kg 23 October 2023

A test result from at least one in vivo study on the chemical or from suitable read across information, as detailed below, with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available):

- conducted following an acceptable test guideline for subacute oral toxicity, in which the NOAEL (oral) is ≥300 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

- conducted following an acceptable test guideline for subchronic oral toxicity, in which the NOAEL (oral) is ≥100 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

- conducted following an acceptable test guideline for subacute dermal toxicity, in which the NOAEL (dermal) is ≥600 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

- conducted following an acceptable test guideline for subchronic dermal toxicity, in which the NOAEL (dermal) is ≥200 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

- conducted following an acceptable test guideline for subacute inhalation toxicity, in which there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or the NOAEC (inhalation) is:

- for gases - ≥750 ppmV/6 h/day, or

- for vapours - ≥3 mg/L/6 h/day, or

- for dusts/mists/fumes - ≥0.6 mg/L/6 h/day, or

- conducted following an acceptable test guideline for subchronic inhalation toxicity, in which there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or the NOAEC (inhalation) is:

- for gases - ≥250 ppmV/6 h/day, or

- for vapours - ≥1 mg/L/6 h/day, or

- for dusts/mists/fumes - ≥0.2 mg/L/6 h/day.

OECD Test 407: Repeated Dose 28-day Oral Toxicity Study in Rodents

(EU Annex V test method B.7; OCSPP 870.3050)

OECD Test 408: Repeated Dose 90-Day Oral Toxicity Study in Rodents

(EU Annex V test method B.26; OCSPP 870.3100; OPPT 798.2650; OPP 82-1)

OECD Test 409: Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents

(EU Annex V test method B.27; OCSPP 870.3150; OPP 82-1)

OECD Test 410: Repeated Dose Dermal Toxicity: 21/28-day Study

(EU Annex V test method B.9; OCSPP 870.3200; OPP 82-2)

OECD Test 411: Subchronic Dermal Toxicity: 90-day Study

(EU Annex V test method B.28; OCSPP 870.3250; OPPT 798.2250; OPP 82-3)

OECD Test 412: Subacute Inhalation Toxicity: 28-Day Study

(EU Annex V test method B.8)

OECD Test 413: Subchronic Inhalation Toxicity: 90-day Study

(EU Annex V test method B.29; OCSPP 870.3465; OPPT 798.2450; OPP 82-4)

 

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