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Toxicological information

Skin irritation / corrosion

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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.

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