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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 28 JUL 1992 to 31 JUL 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EPA-TSCA 40 CFR 798
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- 4 male /2 female animals tested
- Source: Ace animals
- Weight at study initiation: 2 to 2.6 kg
- Housing: 1/ cage in suspended
- Diet: Fresh purina rabbit chow (Diet #5321) was provided daily
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light):12 /12

4 male /2 female animals tested

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g was pasted with distilled water
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
6 (4 male/ 2 female)
Details on study design:
TEST SITE
- Area of exposure: 6 cm² covered with gauze patch
- Type of wrap if used: semiocclusive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently washung with distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD TG 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
- there were no edema or erythema detectable (score 0) at any time point in any animal
Other effects:
During the whole testing period the skin at the dose site remained purple coloured. One animal showed systemic effects (diarrhea and soiled anogenital region) at the 24 and 48 hour reading which disapeared until the 72 hour reading.

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 2, 9-Dichloroquinacridone is not irritating to skin under these test conditions. 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 2, 9-Dichloroquinacridone was subject to an acute dermal irritation/corrosion test in 6 New Zealand white rabbits similar to OECD TG 404. Beside the purple staining of the dose site, no relevant skin reactions occurred during the 4 h exposure to 500 mg of test item (pasted with distilled water) as well as during the following 72 h observation period. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.