Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well reported study, no information about housing

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
0.5 ml of the product has been applied on shaved intact and scratched skin once
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
25% solution in water

Test animals

Species:
rabbit
Strain:
other: SPF-Albino-Russen-Kaninchen
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 - 2 kg
- Housing: individual cages
- Diet (e.g. ad libitum): Mischfutter ERKA 8300 der Futtermittelwerke Robert Koch oHG/ Hamm ad libitum
- Water (e.g. ad libitum): Tapwater ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
24h
Observation period:
72h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: surgical gauze


SCORING SYSTEM:
- Detailed in the article annex

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Score:
0.08
Max. score:
4
Reversibility:
fully reversible within: 72 h

Any other information on results incl. tables

SVS only showed symptoms of slight irritation for 1 rabbit

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information