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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
6,8-dianilinonaphthalene-1-sulphonic acid
EC Number:
204-970-8
EC Name:
6,8-dianilinonaphthalene-1-sulphonic acid
Cas Number:
129-93-1
Molecular formula:
C22H18N2O3S
IUPAC Name:
6,8-dianilinonaphthalene-1-sulfonic acid
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: twelve to sixteen weeks
- Weight at study initiation: 2.20 - 2.55 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol, ad libitum
- Water (e.g. ad libitum): mains drinking water, ad libitum
- Acclimation period: minimum period of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 52 - 65
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
not specified
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test material, moistened with 0.5 ml of distilled water
Duration of treatment / exposure:
four hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patch secured with a strip of surgical adhesive tape and wrapped with an elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with cotton wool soaked in diethyl ether
- Time after start of exposure: four hours after application

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): Approximately 1 hour following the removal of the patches, and 24, 48, 72 hours and 7 days later

SCORING SYSTEM:
- Method of calculation: mean of the 24, 48, 72 hours reading for each rabbit

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: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility inapplicable due to missing effects
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility inapplicable due to missing effects
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Other effects:
faint yellow-coloured staining caused by the colour of the test material

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
/ consequently classification according to REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT not warrantable
Conclusions:
Mean scores of animal # 1 / 2 / 3:

Erythema: 1.0 / 0.3 / 1.0
Edema: 0.0 / 0.0 / 0.3

not irritant
Executive summary:

The substance was tested for skin irritation according to OECD guideline 404. Three New Zealand White rabbits 0.5 g of the test material was placed on the shorn skin and fixed with a patch. After removal of the patches the skin was examined for irritation. Very slight erythema was noted but found to be reversible. Therefore, the substance does not fulfill the requiements for classification.