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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
Study period:
1975-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
14 h/d light period. Occlusive dressing. Vehicle not specified. Dose not specified. 24 h exposure.
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: organic- Physical state: solid

Test animals

Species:
rabbit
Strain:
other: Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 - 2 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum, standard rabbit food (NAFAG, Gossau SG)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 / 14

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: not mentioned
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not specified

VEHICLE
- Amount(s) applied (volume or weight with unit): not specified
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: entire back and the flank
- Type of wrap if used: impermeable material fastened to the body of the rabbit with adhesive tape

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
8
Reversibility:
fully reversible
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
8
Reversibility:
fully reversible
Other effects:
none reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The primary irritation index, a measure of the acute irritation to the rabbit skin was 0. This indicates that the substance is not an irritant to the rabbit skin.