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

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

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 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

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

A suitable in silico prediction indicating that the chemical is not irritating to skin or has no alerting groups for skin irritation

A suitable in silico prediction indicating that the chemical is not irritating to the eye

Suitable in silico prediction indicating that the chemical and its metabolites (if any) do not cause skin sensitisation; 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

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

Suitable in silico prediction for acute toxicity (LD50) of the chemical of >2,000 mg/kg bw/day; and

test results from an in vitro study on the chemical or from suitable read across information for acute toxicity (LD50), conducted following an acceptable test guideline for acute oral toxicity, of >300 mg/kg bw

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