Registration Dossier
Registration Dossier
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EC number: 267-990-6 | CAS number: 67969-88-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 - 27 Nov 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate
- EC Number:
- 240-267-2
- EC Name:
- Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate
- Cas Number:
- 16102-99-1
- Molecular formula:
- C22H18N2O11S3.2Na C22H16N2Na2O11S3
- IUPAC Name:
- disodium 1-amino-9,10-dioxo-4-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)amino]-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Albino New Zealand Rabbit
Source: Hoechst AG
Food: Altromin 2123 for rabbits
Water: deionised and chlorinated water
Food and water ad libitum
Single housing
Weight: 2.3 to 2.7 kg
Age: ca. 3 - 5 months
Temperatur: 20°C
Relative air humidity: 50%
Light: 12/12 hours
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- 500 mg (pasting with 0.3 mL physiological saline) on 2.5 cm x 2.5 cm cellulose patches
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 30 min, 60 min, 24 h, 48 h, 72 h after exposure end
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure shaved skin: 2.5 x 2.5 cm
- Type of wrap if used: 2.5 x 2.5 cm cellulose patch, semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours, washed with tepid water
SCORING SYSTEM: OECD TG 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- no irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- no irritation
- Remarks on result:
- no indication of irritation
- Other effects:
- Up to 60 min after exposure, 3 / 3 animals showed large-scale discolouration (blue). After 24 h, still 2 / 3 animals showed the discolouration (blue).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No irritating effect on rabbit skin was observed after 24/48/72 h (erythema/edema score). The test item does not meet the classification criteria according to the CLP Regulation.
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