Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
fish early-life stage toxicity
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS:
Fish, Early-life Stage Toxicity Test (OECD 210 according GLP).

NON-CONFIDENTIAL NAME OF SUBSTANCE:
Chemical registery number : 953-378-2
Chemical name : Benzenesulfonic acid, 4-C10-13-alkyl derivs.-, salts with amines, C16-C18 (even numbered) alkyl. (For more details, please refer to the Test Material Information part).

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 : There are no existing GLP studies on fish.
- Available non-GLP studies : There are no existing non-GLP studies on fish.
- Historical human/control data : None
- (Q)SAR : not relevant
- In vitro methods : not applicable
- Weight of evidence : None
- Grouping and read-across : None
- Substance-tailored exposure driven testing [if applicable] : not applicable
- Approaches in addition to above [if applicable] : not applicable
- Other reasons [if applicable] : none

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:
- There are no existing GLP studies on fish according REACH Annex VIII. The acute fish test is waived due to the high insolubility of the registered substance. The water solubility for the registered substance is less than < 64,3 µg/L at 20.0+0.5°C according a flask method test (OECD 105 and GLP). According to REACH column 2, Annex VIII a long-term study on fish (Annex IX section 9.1.6) shall be considered if the substance is poorly water soluble.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
none

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Test material

1
Chemical structure
Reference substance name:
Benzenesulfonic acid, 4-C10-13-alkyl derivs.-, salts with amines, C16-C18 (even numbered) alkyl
Molecular formula:
[(CnH2n+1)NH3+].[(CxH2x+1)-C6H4-S03-]
IUPAC Name:
Benzenesulfonic acid, 4-C10-13-alkyl derivs.-, salts with amines, C16-C18 (even numbered) alkyl
Test material form:
liquid: viscous
Details on test material:
Chemical registery number : 953-378-2
Chemical name : Benzenesulfonic acid, 4-C10-13-alkyl derivs.-, salts with amines, C16-C18 (even numbered) alkyl

Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agreed by each registrant.

Results and discussion

Applicant's summary and conclusion