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It is reasonably expected that the person named in the Chemical information holder field will provide the AICIS Executive Director with requested information for this chemical on the basis of our signed Memorandum of Understanding / notes of our phone discussions / minutes of our meetings / email correspondence and further as follows:

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Acknowledged

Information to demonstrate that the chemical is a biological chemical

Information that demonstrates that the chemical has a solubility in water that is >5 g/L, measured following an acceptable test guideline for water solubility

OECD Test 105: Water Solubility

(OPPTS 830.7840)

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)

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 >10 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 >1 mg/L (for chemicals that are not readily biodegradable), or

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

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)

Information that demonstrates the absence of mutagenic or genotoxic effects from both:

- information on the chemical or from suitable read across information that addresses gene mutations - this could be:

* a suitable in silico prediction, both with and without metabolic activation, or

* test results from a study conducted following an acceptable test guideline for gene mutations; and

- test results from a 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

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

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)

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

Results from a defined approach (combination of tests) described in OECD 497, with a non-sensitising prediction*.

Note that negative results only with key event 1 and key event 2 adverse outcome pathway (AOP) assays will not rule out skin sensitisation potential for some weak skin sensitisers and pre-/pro-hapten fragrance chemicals when using the '2 out of 3' (2o3) defined approach and hence this should be considered when determining an appropriate testing methodology. For further information see: ENV/CBC/MONO(2021)11. Supporting Document to the OECD Guideline 497 on Defined Approaches for Skin Sensitisation (https://one.oecd.org/document/ENV/CBC/MONO(2021)11/en/pdf).

OR all of the following:

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 the adverse outcome pathway for 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)

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)

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)