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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

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.

Data source

Reference
Reference Type:
publication
Title:
OECD SIDS ALIPHATIC ACIDS CATEGORY
Author:
SIDS Initial Assessment Report
Year:
2014

Materials and methods

Test guideline
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:

Test material

1
Reference substance name:
not applicable
Molecular formula:
not applicable
IUPAC Name:
not applicable
Specific details on test material used for the study:
Not specified

Method

Target gene:
Not specified
Species / strain
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
Controls
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

Results and discussion

Test results
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

Applicant's summary and 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.