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:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
other: Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: single housing in V2A wire cages
- Diet: NAFAG (Gossau SG, rabbit food), ad libitum
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and slightly scarified on the left side
Vehicle:
other: Polyethylene glycol (PEG 400)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 50 % polyethylene glycol suspension
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6 (3 males / 3 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5*2.5 cm (on both sides)
- Type of wrap if used: The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h and 72 h after application
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h and 72 h after application
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met