Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
in vivo
Type of information:
other: read across from similar substance
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
Department of Toxicology (BASF AG)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, FRG
- Weight at study initiation: mean 2.91 kg (males), 2.59 kg (females)
- Housing: individually in stainless steel cages with wire mesh walk floors, floor area: 40 cm x 51 cm
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm, Muskator-Werke, D-4000 Duesseldorf 1, FRG (about 130 g per animal per day)
- Water (e.g. ad libitum): tap water (about 250 ml per animal per day )
- Acclimation period: at least 8 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Clipping of the fur at least 15 hours before the beginning of the study
Vehicle:
water
Controls:
other: untreated skin site of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mm layer suspension (thus about 0.5 g of the test substance)
- Concentration (if solution): 50%
Duration of treatment / exposure:
4 h
Observation period:
8 days
Number of animals:
3 (1 male/2 female )
Details on study design:
TEST SITE
- Area of exposure: third of the back or flank
- Type of wrap if used: test patch (2.5 x 2.5 cm) secured in position with a porous dressing (4 layers of absorbent gauze + porous bandage)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h


SCORING SYSTEM:
Evaluation of erythema and edema:
0 - None
1 - Very slight
2 - Well-defined
3 - Moderate to severe
4 - Severe

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: mean 24, 48, 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Any other information on results incl. tables

Animal1: male, 2.91 kg

Animal 2: female, 2.69 kg

Animal 3: female, 2.49 kg

Readings:

Readings Animal Erythema Edema Additional findings
4 h 1 1 0  
2 1 0  
3 1 0  
24 h 1 0 0  
2 0 0  
3 1 0  
48 h 1 0 0  
2 0 0  
3 0 0  
72 h 1 0 0  
2 0 0  
3 0 0  
8 d 1 0 0  
2 0 0  
3 0 0  
mean 24 - 72 h 1 0.0 0.0  
2 0.0 0.0  
3 0.3 0.0  
mean 24 - 72 h 0.1 0.0  

Applicant's summary and conclusion

Interpretation of results:
other: not classified unre Regulation 1272/2008