Alcohols, C13-15-branched and linear

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study planned

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Alcohols, C13-15-branched and linear / 85566-16-1 / 287-625-4

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: No GLP-studies available
- Available non-GLP studies: No non-GLP-studies available
- Historical human data: Not relevant
- (Q)SAR: No valid QSAR methods available to reliably estimate the long-term toxicity to fish for the UVCB Alcohols, C13-15-branched and linear
- In vitro methods: Not applicable
- Weight of evidence: No data for weight of evidence approach available
- Grouping and read-across: There is no data available for structurally similar UVCB and the UVCB is not member of a category. Thus, predicting the long-term toxicity on fish based on a read-across is not possible.
- Substance-tailored exposure driven testing: Not applicable
- Approaches in addition to above: Not applicable

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- The specific adaptation possibilities of ANNEX IX are not adequate to generate the necessary information, consequently there is a data gap regarding the long-term toxicity on fish. Long-term toxicity testing on fish is a standard information requirement in Annex IX to REACH (Annex IX, Section 9.1.6). Additionally the substance is poorly water soluble (0.68 mg/L). For hydrophobic or poorly water soluble (e.g. water solubility below 1 mg/L or below the detection limit of the analytical method of the test substance), long-term tests shall be considered (REACH Annex VIII, Section 9.1.3, Column 2).

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: Due to the low solubility of the substance in water and that the substance is an UVCB, the OECD GD 23 and ECHA Guidance, Chapter R7b, Table R.7.8-3 relating to the aquatic toxicity testing of difficult substances will be consulted, so that the most appropriate design of the study will be chosen and testing close to or at the limit of water solubility is possible.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C13-15-branched and linear

EC Number:

287-625-4

EC Name:

Alcohols, C13-15-branched and linear

Cas Number:

85566-16-1

Molecular formula:

C13 H27 OH - C15 H31 OH

IUPAC Name:

Alcohols C13-C15 branched and linear, reaction products of C12-C14 olefines

Test material form:

liquid

Details on test material:

Name of test substance: C13-C15-Alcohol
Test substance No.: 20/0140-2
Batch identification: TK2004-02122020
CAS No.: 85566-16-1
Identity: confirmed
Purity: 100% UVCB
Water content: 0.01 g/100 g
Homogeneity: The homogeneity of the test substance was ensured by mixing before preparation of the test substance solutions.
Storage stability: The stability of the test substance under storage conditions is guaranteed until 02 Dec 2021 as indicated by the sponsor, and the sponsor holds this responsibility. The test facility is organizationally independent from the BASF SE sponsor division.
Date of production: 02 Dec 2020
Physical state, appearance: liquid, colorless, clear
Storage conditions: room temperature