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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

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

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

Test material

Constituent 1
Reference substance name:
Analogue Substance_01
IUPAC Name:
Analogue Substance_01

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system 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:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
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 under Regulation 1272/2008