Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

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.