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EC number: 435-080-1 | CAS number: 1070-64-0 6,8-DICHLORETHYLCAPRYLAT; ETHYL-6,8 DICHLORO OCTANOATE
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
According to the result of AMES Test, 6,8-Dichloroethylcaprylate is not mutagenic with the strains of Salmulella typhimurium TA 97, TA98, AT100, TA102 and TA1535 up to 900µg/plate (2700µg/plate with S9 mix) which ist the limit of toxicity
6,8 Dichloroethylcaprylat did not cause cytotoxic effects at the concentrations tested and there was, under the conditions of this study, no evidence that 6,8 Dichloroethylcaprylat did induce chromosomal abberrations in cultured human lymphocytes.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Oct 1998 to 13 Nov 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Batch: Ds 1099
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- highest dose 2700µg/plate; at this dose precipitation occurred.
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- 2-nitrofluorene
- other: 2-Aminoanthracene; 1,8 Dimethylbenz-a-anthracene
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- According to these results, 6,8-Dichloroethylcaprylate is not mutagenic in the Ames test with the strains of Salmulella typhimurium TA 97, TA98, AT100, TA102 and TA1535 up to 900µg/plate (2700µg/plate with S9 mix) which ist the limit of toxicity
- Executive summary:
According to these results, 6,8-Dichloroethylcaprylate is not mutagenic in the Ames test with the strains of Salmulella typhimurium TA 97, TA98, AT100, TA102 and TA1535 up to 900µg/plate (2700µg/plate with S9 mix) which ist the limit of toxicity
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13. Dec 1999 to 9 April 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
- Specific details on test material used for the study:
- Batch: Ds 1099
- Species / strain / cell type:
- lymphocytes: human
- Details on mammalian cell type (if applicable):
- - Whole blood from healthy 43 - 47 y. o. men
- Na-Heparinized vessels - Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 Mix
- Test concentrations with justification for top dose:
- 3; 11; 33 and 100 µg/mL Test substance in DMSO. no higher concentration possible als test substance solubility in water is very low.
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- methylmethanesulfonate
- Key result
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- 6,8 Dichloroethylcaprylat did not cause cytotoxic effects at the concentrations tested and there was, under the conditions of this study, no evidence that 6,8 Dichloroethylcaprylat did induce chromosomal abberrations in cultured human lymphocytes.
- Executive summary:
6,8 Dichloroethylcaprylat did not cause marked cytotoxicity at any of the concentrations tested.
Neither with nor without the use of a metabolic activation system a statistically significant increase in the number of gaps or in the number of metaphases with numerical aberrations compared to the concurrent negative controls was noted.
Neither with nor without the use of a metabolic acctivation system a statistically significant increase in the number of metaphases with structural aberrations was noted at any concentrations analysed, neither after treatment for 3 hours nor for 20 hours.
6,8 Dichloroethylcaprylat did not cause cytotoxic effects at the concentrations tested and there was, under the conditions of this study, no evidence that 6,8 Dichloroethylcaprylat did induce chromosomal abberrations in cultured human lymphocytes. The conclusion is based on the lack of a statistically significant increase of metaphases with structural aberrations in any experiment and on a lack of a concentatios dependent increase of metaphases with structural aberrations.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In one study according to OECD 471 and in one study according to EU Methode B.10 there have been no effects therfore no classification is necessary.
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