Registration Dossier
Registration Dossier
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EC number: 266-867-4 | CAS number: 67674-28-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Apr 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate
- EC Number:
- 266-867-4
- EC Name:
- Sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate
- Cas Number:
- 67674-28-6
- Molecular formula:
- C26H25N5O5S.Na
- IUPAC Name:
- sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Acid Red 299
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- HC:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill ltd., Huntingdon, UK
- Weight at study initiation: mean: 2.7 Kg
- Housing: individual cages
- Diet: standard diet "ssniff K" ad libitum
- Water: tab water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4h
- Observation period:
- max. 14d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: flanks of the rabbits
- coverage: 2.5 x 2.5 cm
- Type of wrap if used: gauze fixated with bandage
REMOVAL OF TEST SUBSTANCE
- Washing: treated areas were washed with water
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
1h, 24h, 48h, 72h, 7d, 14d
SCORING SYSTEM: Draize grades
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
Any other information on results incl. tables
| Animal No | Endpoint | Observation time | ||
| 24h | 48h | 72h | ||
| I | erythema | 0 | 0 | 0 |
| edema | 0 | 0 | 0 | |
| II | erythema | 0 | 0 | 0 |
| edema | 0 | 0 | 0 | |
| III | erythema | 0 | 0 | 0 |
| edema | 0 | 0 | 0 | |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is determined as not irritating and non-corrosive to rabbit skin under the conditions of the test.
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