Registration Dossier
Registration Dossier
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EC number: 204-970-8 | CAS number: 129-93-1
Skin irritation / corrosion
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:
- 1 991
- 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
- 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-bis(phenylamino)naphthalene-1-sulfonic acid
- Test material form:
- solid
Constituent 1
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.
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