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

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

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

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

OECD Test 202: Daphnia sp. Acute Immobilisation Test

OECD Test 203: Fish, Acute Toxicity Test

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

OECD Test 211: Daphnia magna Reproduction Test

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

OECD Test 473: In Vitro Mammalian Chromosomal Aberration Test

OECD Test 474: Mammalian Erythrocyte Micronucleus Test

OECD Test 475: Mammalian Bone Marrow Chromosomal Aberration Test

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

OECD Test 478: Rodent Dominant Lethal Test

OECD Test 485: Genetic toxicology, Mouse Heritable Translocation Assay

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

OECD Test 487: In Vitro Mammalian Cell Micronucleus Test

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

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

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

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

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

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

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

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

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

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

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

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

OECD Test 429: Skin Sensitisation

OECD Test 442A: Skin Sensitization

OECD Test 442B: Skin Sensitization

OECD Test 442C: In Chemico Skin Sensitisation

OECD Test 442D: In Vitro Skin Sensitisation

OECD Test 442E: In Vitro Skin Sensitisation

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 403: Acute Inhalation Toxicity

OECD Test 420: Acute Oral Toxicity - Fixed Dose Procedure

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

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

OECD Test 433: Acute Inhalation Toxicity: Fixed Concentration Procedure

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

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

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

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

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

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

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

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