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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:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See chapter 13 for detailed read across justification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,5-diaminobromo-4,8-dihydroxyanthraquinone
EC Number:
250-817-3
EC Name:
1,5-diaminobromo-4,8-dihydroxyanthraquinone
Cas Number:
31810-89-6
Molecular formula:
C14H9BrN2O4
IUPAC Name:
1,5-diamino-2-bromo-4,8-dihydroxy-9,10-anthraquinone
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Identification: FAT 36002/G TE
Lot: DX201409-01
Appearance: Dark blue powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
Test substance: FAT 40284/A
Batch No.: EN 47342.52
Contents of active ingredients : 29.3 %
Physical properties: powder; dispersible in water; pH: 9.0 (lg/1 water)
Storage conditions: room temperature
Validity: November 1991
Safety precautions: gloves and face masks
Test material received: December 12, 1986

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2370 t o 2580 g
- Housing: individually in metal cages, identified with individually numbered ear tags ,
- Diet: ad libitum standard rabbit pellet - Nafag
No. 814, Gossau, Switzerland
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C
- Humidity: 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day

IN-LIFE DATES: From: February 3, 1987 To: February 10, 1987

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: one flank of each animal served as a control flank
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6 square cm

OBSERVATION TIME POINTS
- 1, 24, 48, and 72 hours after removing the gauze patches

SCORING SYSTEM:
- Method of calculation: OECD scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Other effects:
A moderate loss of weight was observed in animal No. 31 on day 3 and 7.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40284/A is considered to be not a skin irritant.
Executive summary:

An acute skin irritation/corrosion study in albino rabbits was performed to determine, the irritant or corrosive potency of FAT 40284/A on the albino rabbit skin. This test was based on the OECD guideline No. 404. The test was performed on 3 male rabbits. A gauze patch (20 cm) bearing 0.5 g of the test substance was applied to the shaved flank. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. Under the experimental conditions employed FAT 40284/A induced erythema and edema reactions when applied to the clipped albino rabbit skin. Because the mean values of the recordings 24 to 72 hours after application are below the threshold of significance FAT 40284/A can be classified as non-irritant.