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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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1987
Deviations:
not applicable
Remarks:
4-hour application
Principles of method if other than guideline:
The test item were applied to clipped skin of three rabbits for 4 hours and the readings were performed after 30 minutes and 24, 48 and 72 hours.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Acid Black 076
IUPAC Name:
Acid Black 076
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Gender: male
- Housing: all animals were housed in individual cages
- Diet: a standard laboratory diet were provided ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Humidity: 30 to 70 %
- Air changes: 15 changes/hour
- Photoperiod: the light/dark cycle was 12 hours

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
WEM
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 1 ml
- Preparation: diluted with WEM
Duration of treatment / exposure:
4 hours
Observation period:
30 minutes, 24, 48 and 72 hours
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: back of the animals
- Preparation: 24 hours prior to the test, the skin on the back of the animals was clipped by means of an electric clipper and the skin was investigated for pre-existing injuries
- Area of coverage: 6.5 cm²
- Type of wrap if used: surgical gauze
- Other: the animals were immobilised with patches secured in place by a plastic patch and the entire trunk was wrapped with a plastic sleeve for the 4 hour exposure

SCORING SYSTEM
Erythema and Edema:
0 - No finding
1 - Barely perceptible effect
2 - Slight, well defined effect
3 - Moderate
4 - Severe

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intact skin

Any other information on results incl. tables

Table 1: Results.

Animal no. Symptom 30 minutes 24 hours 48 hours 72 hours
no. 4 (male) Erythema intact skin 0 0 0 0
Oedema intact skin  0 0 0 0
no. 5 (male) Erythema intact skin 0 0 0 0
Oedema intact skin  1 1 0 0
no. 6 (male) Erythema intact skin 0 0 0 0
Oedema intact skin  1 1 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC) no. 1272/2008
Conclusions:
The test item was found to be not irritating to rabbit skin in vivo
Executive summary:

The skin irritation potential of the test item was evaluated in an in vivo experimental study equivalent to the OECD Guideline 404 (1987). 1 ml of test item diluted in WEM was applied to the clipped skin of three male, New Zealand White rabbits for 4 hours using an occlusive dressing, and skin was monitored for erythema and oedema at 30 minutes, 24, 48 and 72 hours.

The mean (24/48/72 hours) erythema scores were 0 in all animals; mean (24/48/72 hours) oedema scores were 0 in animal #1, and 0.33 in animals #2 and #3, and oedema was reversible within 48 hours.