Registration Dossier
Registration Dossier
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EC number: 280-116-8 | CAS number: 83006-67-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct 1976
- 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:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Disodium 2,2'-[(9,10-dihydro-5,8-dihydroxy-9,10-dioxo-1,4-anthrylene)diimino]bis[5-tert-butylbenzenesulphonate]
- EC Number:
- 280-116-8
- EC Name:
- Disodium 2,2'-[(9,10-dihydro-5,8-dihydroxy-9,10-dioxo-1,4-anthrylene)diimino]bis[5-tert-butylbenzenesulphonate]
- Cas Number:
- 83006-67-1
- Molecular formula:
- C34H34N2O10S2.2Na
- IUPAC Name:
- Disodium 2,2'-[(9,10-dihydro-5,8-dihydroxy-9,10-dioxo-1,4-anthrylene)diimino]bis[5-tert-butylbenzenesulphonate]
- Test material form:
- solid
- Details on test material:
- Acid Green 81
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd, Huntingdon, UK
- Weight at study initiation: 3 - 4 kg
- Housing: one animal per cage
- Diet (e.g. ad libitum): Ssniff K4 (Versuchstierdiäten GmbH), ad libitum
- Water (e.g. ad libitum): mains water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 40 - 60%
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg test substance applied to a patch - Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 d
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: inner side of one ear
SCORING SYSTEM: Draize
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with water and soap
- Time after start of exposure: 24h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 0, 24, 48, 72h and 4, 5, 6 and 7d
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
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is determined as not irritating to rabbit skin under the conditions of the test. The substance is not classifiable according to CLP criteria.
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