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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:
From 2 APR 1979 to 5 APR 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FDA guideline (Federal Register 38, No. 187, 27.9.1973)
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in house breeding (Hoe:HIMK(SPFWiga))
- Weight at study initiation: 1.5 to 2.5 kg
- Housing: single caged
- Diet: standard diet ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westfalen, Germany), ad libitum
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped, partially scarified
Vehicle:
other: polyethylene glycol 400
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of test substance pasted with 0.7 mL of of PEG400

Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm²
- Type of wrap if used: occlusive elastic bandage
- test item was applied to intact as well as scarified skin of each animal

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

SCORING SYSTEM: described in § 1500.41 in Fed. Reg. 38, No. 187, 27.09.1973, p.27019, in accordance with OECD TG 404.
Scores were assessed 24, 48 and 72 h after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately, 24 and 48 h after end of exposure.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: result for intact as well as scarified skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: result for intact as well as scarified skin
Irritant / corrosive response data:
- none of the animals showed oedema or erythema at the intact or scarified skin at any time point (immediately, 24 and 48 hours after end of exposure)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to skin under these test conditions. This conclusion is legitimate although the testing regime differs from today's standard methods (e.g., exposure of intact and scarified skin, application period 24 hours instead of 4 hours, deviating reading times, scoring system is identical to the currently used system), because no skin reactions were observed in any animal at any timepoint. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Test material was subject to an acute dermal irritation/corrosion test in 6 Himalayan albino rabbits according to FDA guideline. Both intact and scarified skin sites of six rabbits were exposed to 500 mg test substance (pasted in 0.7 mL PEG 400) for 24 h under occlusive conditions and the skin responses were watched for up to 48 hours after end of exposure. No skin reactions were observed. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.