Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Reported in Cosmetic Ingredient Review, 1992 Study performed on Sodium Lauriminodipropionate Primary data not seen, but review considered valid

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Groups of 10 Guinea Pigs were injected 0.1% solutions for a total of 10 injections over 20 days induction period
The animals were rested for two weeks with no treatment and a challenge dose injected near the induction sites.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: dilute solution in water
Details on test material:
Used in water at concentration of 0.1%

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.1%
Challengeopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.1%
No. of animals per dose:
10
Challenge controls:
Not reported

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
0.1 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No adverse effects reported
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No adverse effects reported.

Any other information on results incl. tables

No evidence of sensitisation observed

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No evidence of sensitisation observed
Executive summary:

No evidence of sensitisation observed

Even when considering the absence of key data in the published report, the conclusions made at the time by those undertaking the review are that the substance can be used in dermally applied cosmetic products. Human monitoring is also reported and no evidence of sensitising effects is reported.

No claims for data ownership are made and it is noted that the review relied on data from industry testing on similar substances.

There is no justification to perform further animal tests on this substance, especially in regard to its use in cosmetic products.