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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vitro and in vivo studies
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:
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.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2017

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Data available is referred to Amino Acid Alkyl Amides.
GLP compliance:
not specified

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

In vitro test system

Test system:
other: not specified
Source species:
other: not specified
Cell type:
other: not specified
Cell source:
other: not specified
Source strain:
not specified
Details on animal used as source of test system:
not specified
Justification for test system used:
not specified
Vehicle:
not specified
Details on test system:
not specified
Amount/concentration applied:
not specified
Duration of treatment / exposure:
not specified
Duration of post-treatment incubation (if applicable):
not specified
Number of replicates:
not specified

Test animals

Species:
other: not specified
Strain:
not specified
Details on test animals or test system and environmental conditions:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Amount / concentration applied:
not specified
Duration of treatment / exposure:
not specified
Observation period:
not specified
Number of animals:
not specified
Details on study design:
not specified

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: See conclusion
Run / experiment:
See conclusion
Vehicle controls validity:
other: not specified
Negative controls validity:
other: not specified
Positive controls validity:
other: not specified
Remarks on result:
other: See conclusion
Other effects / acceptance of results:
See conclusion

In vivo

Results
Irritation parameter:
other: See conclusion
Remarks:
See conclusion
Basis:
other: See conclusion
Remarks:
See conclusion
Time point:
other: See conclusion
Reversibility:
not specified
Remarks:
See conclusion
Remarks on result:
other:
Remarks:
See conclusion
Irritant / corrosive response data:
See conclusion

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No irritation was observed in in vitro studies with disodium capryloyl glutamate when tested at concentrations of 1.85% to 2.05%. A cream containing 8% acetyl proline was a mild irritant in another in vitro study. In rabbits, lauroyl lysine was nonirritating when tested at a concentration of 20%, whereas sodium lauroyl glutamate was a mild irritant at a concentration of 5%. In human studies, acetyl proline (up to 10%), acetyl tyrosine (up to 2%), disodium capryloyl glutamate (up to 7.38%), sodium cocoyl glutamate (up to 10%), sodium lauroyl glutamate (up to 10%), and sodium lauroyl silk amino acids (up to 6%) were not dermal irritants
Executive summary:

In human studies, acetyl proline (up to 10%), acetyl tyrosine (up to 2%), disodium capryloyl glutamate (up to 7.38%), sodium cocoyl glutamate (up to 10%), sodium lauroyl glutamate (up to 10%), and sodium lauroyl silk amino acids (up to 6%) were not dermal irritants.