Registration Dossier

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:
other: Comparable to OECD Guideline 404 with acceptable restrictions (occlusive conditions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Fed. Reg. 38, No. 187, § 1500.41, p. 27019 of Sep. 27, 1973
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(occlusive conditions, 72 h reading missing)
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pigmentorange Kan 78/1775
- Test substance number: 80/404
- Physical state: solid, orange
- Analytical purity: > 98 %
- Lot/batch No.: Batch 8

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Mean weight at study initiation: males 2.74 kg (2.96, 2.69, 2.56 kg), females 2.82 kg (3.15, 2.69, 2.61 kg)
- Housing: 1 animal per cage; Cage made of stainless steel with wire mesh walk floor; floor area: 40 cm x 51 cm
- Diet: Ovator Solikanin 4 mm; Muskator-Werke, Düsseldorf 1, Germany (about 130 g per animal daily)
- Water: About 250 mL water per animal daily: fully demineralized water (Mondays - Fridays), tap water (Saturday/Sunday)
- Acclimation period: about 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 50 - 80
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Clipping of fur at least 15 hours before the beginning of the study
Vehicle:
water
Controls:
other: Untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Coating of the test patch with a layer of about 0.5 mm of a 50% formulation (with 2.5 x 2.5 cm about 0.5 g) is applied; due to the natural moistness of the skin, distilled water is used for the preparation of the formulation in order to have nearest to physiological study conditions.
- Concentration (if solution): 50% aqueous formulation

Duration of treatment / exposure:
24 hour(s)
Observation period:
8 days
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm intact and abraded skin each, upper third of the back or flank

REMOVAL OF TEST SUBSTANCE
- Washing: Remaining test substance is wiped off and washing is done with water

SCORING SYSTEM: According to J. H. Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity pp. 46 - 59, 1959. Austin, Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health

READINGS: 24, 48 , and 72 h and 8 d after the beginning of application

ADDITIONAL EXAMINATIONS: After sacrifice the animals are examined by gross pathology. If there are clinical signs of necroses, these are confirmed by gross-pathological examination after incision of the skin.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Reversibility:
other: not applicable
Remarks on result:
other: erythema score could not be read because of staining due to the color of the test substance
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
No effects were observed 8 days after treatment.
Other effects:
No other effects observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
CLP: not classified
DSD: not classified