Registration Dossier

Toxicological information

Skin irritation / corrosion

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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: basic data given, comparable to guideline/standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Principles of method if other than guideline:
according to Draize: Appraisal of the safety of chemicals in foods, drugs and cosmetics. In dermal toxicity pp. 46 - 59, 1959.
Austin, Tex.: Association of food and drug officials of the United Staates, Texas, State Department of Health.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
Animal species: Rabbit / White Vienna (2 females), breeder: Gaukler, Germany
Animal weights: 3.1 resp. 3.02 kg
Type of cage: Cage made of stainless steel with wire mesh walk floor, floor area about 40 cm x 51 cm
No. of animals per cage: 1
Animal identification: Ear tattoo
Room temperature: 20 - 26°C
Relative humidity: about 30 - 70%
Day/night rhythm: 12 h / 12 h
Bedding: No bedding in the cages, saw dust in the waste trays
Diet: Ovator Sokikanin 4 mm, Duesseldorf, Germany
Drinking water: About 250 ml per animal
Acclimatization period: About 8 days before the beginning of the study in the laboratory, same housing conditions as during the study

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
Application area: 2.5 x 2.5 cm
Volume applied: Coating of the test patch with the undiluted test substance
Appl. site: back or flank

Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
Removal of the test substance: no
Readings: 15 - 30 minutes after removal of the test patches and 24 h, 48 h, 8 d after beginning of application
Scoring according to Draize

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information