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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation, other
Remarks:
in vitro and in vivo data
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:
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:
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
Type of study:
not specified
Justification for non-LLNA method:
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 vivo test system

Test animals

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

Results and discussion

Positive control results:
not specified

In vitro / in chemico

Results
Key result
Parameter:
other: See conclusion
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: See conclusion
Other effects / acceptance of results:
not specified

In vivo (non-LLNA)

Results
Key result
Reading:
other: not specified
Hours after challenge:
0
Group:
other: not specified
Dose level:
not specified
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
not specified
Remarks on result:
other: See conclusion

In vivo (LLNA)

Results
Key result
Parameter:
other: See conclusion
Variability:
not specified
Test group / Remarks:
not specified
Remarks on result:
other: See conclusion
Cellular proliferation data / Observations:
not specified

Any other information on results incl. tables

not specified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Sodium lauroyl silk amino acids when tested in a 20% solution were not sensitizing in an LLNA. In guinea pigs, lauroyl lysine and sodium lauroyl glutamate were not sensitizers at concentrations of 50% and 5%, respectively. No sensitization was observed in human studies with products containing acetyl hydroxyproline (up to 2%), acetyl proline (up to
10%), acetyl tyrosine (up to 2%), disodium capryloyl glutamate (up to 7.38%), lauroyl lysine (up to 12.5%), sodium cocoyl glutamate (up to 5%), and sodium lauroyl glutamate (up to
5%).
Executive summary:

No sensitization was observed in the susbtances of the category.