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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
(mostly due to limited documentation before GLP (no data on test substance purity); Draize-test)

Data source

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

Materials and methods

Test guideline
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) / Draize
GLP compliance:
no

Test material

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

Test animals

Species:
rabbit
Strain:
other: Russian breed
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.2 to 1.9 kg
- Housing: individually
- Diet: standard diet of Nafag, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 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:
other: shaved: intact and abraded skin
Vehicle:
other: moistened with tap water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
6 (3 male and 3 female animals)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The gauze patch with the test substance was covered with an impermeable foil of 5 x 5 cm, which was fixed to the body of the animals with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: no washing conducted

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(animal 1-6)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
(animal 1-6)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact and abraded skin
Irritant / corrosive response data:
No erythema and edema were observed in any animal during the whole observation period.

Any other information on results incl. tables

Only the results from the intact skin were taken into account for assessment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met