Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Link to relevant study records
- Endpoint:
- genetic toxicity in vitro, other
- Remarks:
- Ames test and Chromosomal aberration assay
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data are being assessed for the use in a category approach. Available information are being judged as reliable with restrictions since it was conducted by a modeled and measured data
- Remarks:
- Data are being assessed for the use in a category approach. Available information are being judged as reliable with restrictions since it was conducted by a modeled and measured data
- Justification for type of information:
- Important considerations for the read-across were:
Sodium Olivoyl Glutamate (the target chemical) has similar physico-chemical properties as the others members:
- "Aliphatic acid category" (the source chemicals);
- "Amino acid alkyl amides category" (the source chemicals);
- Sodium oleoyl glutamate (the source chemicals);
Key points are that the members share:
- the same structural features
- similar metabolic pathways
- common levels and mode of human health related effects
- function. - Qualifier:
- no guideline available
- Principles of method if other than guideline:
- data available is referred to Aliphatic acids category.
- GLP compliance:
- no
- Type of assay:
- other:
- Specific details on test material used for the study:
- Not specified
- Target gene:
- Not specified
- Species / strain / cell type:
- other: Ames test and Chromosomal aberration assay
- Details on mammalian cell type (if applicable):
- Not specified
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- Not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Not specified
- Test concentrations with justification for top dose:
- Not specified
- Vehicle / solvent:
- Not specified
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- Not specified
- Rationale for test conditions:
- Not specified
- Evaluation criteria:
- Not specified
- Statistics:
- Not specified
- Key result
- Species / strain:
- other: Ames test and Chromosomal aberration assay
- Metabolic activation:
- not specified
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- not specified
- Remarks on result:
- other: See conclusion
- Remarks:
- See conclusion
- Conclusions:
- Gene mutation data (in vitro bacterial and in vitro mammalian studies) are available for the substances of the category these studies were consistently negative.
- Executive summary:
Aliphatic acids are not mutagenic or clastogenic in vitro and the supporting aliphatic acids are not mutagenic or clastogenic in vitro or in vivo. Studies were similar to OECD 471 and 473. The weight of evidence indicates that members of the aliphatic acids group are not anticipated to be genotoxic.
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Ames test and Chromosomal aberration assay
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Important considerations for the read-across were:
Sodium Olivoyl Glutamate (the target chemical) has similar physico-chemical properties as the others members:
- "Aliphatic acid category" (the source chemicals);
- "Amino acid alkyl amides category" (the source chemicals);
- Sodium oleoyl glutamate (the source chemicals);
Key points are that the members share:
- the same structural features
- similar metabolic pathways
- common levels and mode of human health related effects
- function. - Qualifier:
- no guideline available
- Principles of method if other than guideline:
- data available is referred to Amino Acid Alkyl Amides
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Not specified
- Target gene:
- Not specified
- Species / strain / cell type:
- other: Ames test and Chromosomal aberration assay
- Details on mammalian cell type (if applicable):
- Not specified
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- Not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Not specified
- Test concentrations with justification for top dose:
- Not specified
- Vehicle / solvent:
- Not specified
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- Not specified
- Rationale for test conditions:
- Not specified
- Evaluation criteria:
- Not specified
- Statistics:
- Not specified
- Key result
- Species / strain:
- other: Ames test and Chromosomal aberration assay
- Metabolic activation:
- not specified
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- not specified
- Remarks on result:
- other: See conclusion
- Remarks:
- See conclusion
- Conclusions:
- In in vitro studies, acetyl glutamic acid, acetyl proline, acetyl tyrosine, disodium capryloyl glutamate, sodium cocoyl glutamate, and sodium lauroyl glutamate were negative for genotoxicity. Acetyl cysteine was not genotoxic in an Ames test but had positive results in in vitro mouse lymphoma test. Acetyl cysteine and acetyl glutamic acid were negative in in vivo mouse studies-
- Executive summary:
Amino Acid Alkyl Amides are not genotoxicity.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Overall, considering available data on the category members (i) in vitro bacterial and (ii) in vitro mammalian studies the substance is not considered mutagen.
Justification for classification or non-classification
According to Regulation (EC) n. 1272/2008, the substance should not be classified for the genetic toxicity because the available data are judged as "conclusive but not sufficient for classification".
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
