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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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Russian breed
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5-2 kg
- Housing: individually
- Diet: rabbit food (NAFAG, Gossau SG) ad libitum
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and one flank intact, one flank scarified
Vehicle:
other: polyethylene glycol 400
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration: 50% polyethylene glycol (PEG 400) trituration.
Duration of treatment / exposure:
24 h
Observation period:
48 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm² gauze patch.
- Type of wrap if used: plastic film 5x5 cm, fixed with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h.

SCORING SYSTEM: in accordance with OECD TG 404.
Scores were read 24 and 72 h after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately and 48 h after end of exposure.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Erythema score 0 and edema score 0 were noted in every animal immediately and 48 h after exposure.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
The test material is not irritating to skin under these test conditions. This conclusion is legitimate even though the applied testing regime differs from today's standard methods, as no skin reactions were observed in 6/6 animals immediately and 48 h after the end of exposure, which lasted 20 h longer than required by OECD TG 404.
Executive summary:

The test material was subject to a skin irritation test in the rabbit as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Shaved and both intact and scarified skin sites of six rabbits were exposed to 0.5 g test substance in a 50% polyethylene glycol 400 trituration for 24 hours under occlusive conditions. None of the animals showed any skin reactions immediately and 48 hours after the end of exposure. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.