Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
No in vivo data is available for the target substance. However, adequate in vitro data is available for the target substance and therefore, in vivo data is not required. This endpoint study record is additional supporting in vivo data for the source substance.
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Official French methods for cosmetics, Annex I
Deviations:
no
GLP compliance:
not specified
Test material information:
Composition 1
Specific details on test material used for the study:
purity not stated, but "specifications of test material ... corresponding to those regularly employed in industry"
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
other: shaved, tested at intact or abraded skin in parallel
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
100% (undiluted)
Details on study design:
The test procedure is described in the Journal Officiel de la République Française Annexe I, with the following additions or modifications:
Use of occlusive patches "Neodermotest". Fixing of the patches using absorbent gauze held in place by adhesive tape. Housing in individual cages. Modification of the evaluation scoring - non irritant: less than 0.5, and slightly irritant: 0.5 - 2.0.

The results were deemed satisfactory if the index was less than 0.5, but it is still acceptable if it is not greater than 1, taking into account experimental practice.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
0.08
Reversibility:
not specified
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The primary skin irritation index of undiluted test substance was 0.08 (not irritating)
Executive summary:

Rabbits were exposed dermally to single doses of undiluted test substance. No irritation was observed.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion