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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Gene mutation in vitro:

Data available from the read across chemicals was reviewed to determine the mutagenic nature of Alcohols, C8-18, ethoxylated. The studies are as mentioned below:

Salmonella/microsome test in the absence of exogenous metabolic activation and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters was performed to evaluate the mutagenic nature of the test chemical usingS. typhimuriumtester strains TA1535, TA97, TA98 and TA100. The study was performed as per the preincubation assay and the preincubation time was 20 mins and the plates were incubated for 48 hrs. The test compound was dissolved in distilled water and was used at a dosage level of 0, 3.0, 10, 33, 100 or 333 µg/plate in the preincubation assay of 48 hrs. Concurrent solvent and positive control chemicals were included in the study. The test chemical did not induce a reproducible, dose-related increase in his+revertants over the corresponding solventin the S. typhimurium tester strains TA100, TA97, TA1535 and TA98 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Salmonella/microsome mutation assay in the absence of exogenous metabolic activation and in the presence of liver S-9 was also performed to evaluate the mutagenic nature of the test chemical usingS. typhimuriumtester strains TA98, TA100, TA1535, TA1537 and TA1538. The study was performed as per the plate incorporation assay. The test chemical did not induce gene mutation in theS. typhimuriumtester strains TA98, TA100, TA1535, TA1537 and TA1538 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Alcohols, C8-18, ethoxylated is expected to not induce a reproducible, dose-related increase in his+ revertants over the corresponding solvent in the S. typhimurium tester strains in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Gene mutation in vitro:

Data available from the read across chemicals was reviewed to determine the mutagenic nature of the target chemical Alcohols, C8-18, ethoxylated. The studies are as mentioned below:

Salmonella/microsome test in the absence of exogenous metabolic activation and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters was performed to evaluate the mutagenic nature of the test chemical using S. typhimurium tester strains TA1535, TA97, TA98 and TA100. The study was performed as per the preincubation assay and the preincubation time was 20 mins and the plates were incubated for 48 hrs. The test compound was dissolved in distilled water and was used at a dosage level of 0, 3.0, 10, 33, 100 or 333 µg/plate in the preincubation assay of 48 hrs. Concurrent solvent and positive control chemicals were included in the study. The test chemical did not induce a reproducible, dose-related increase in his+revertants over the corresponding solventin the S. typhimurium tester strains TA100, TA97, TA1535 and TA98 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Salmonella/microsome mutation assay in the absence of exogenous metabolic activation and in the presence of liver S-9 was also performed to evaluate the mutagenic nature of the test chemical using S. typhimurium tester strains TA98, TA100, TA1535, TA1537 and TA1538. The study was performed as per the plate incorporation assay. The test chemical did not induce gene mutation in theS. typhimuriumtester strains TA98, TA100, TA1535, TA1537 and TA1538 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Alcohols, C8-18, ethoxylated is expected to not induce a reproducible, dose-related increase in his+ revertants over the corresponding solvent in the S. typhimurium tester strains in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Justification for classification or non-classification

Based on the data available for the read across, Alcohols, C8-18, ethoxylated (CAS no 157707 -43 -2) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.