Registration Dossier
Registration Dossier
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EC number: 229-158-0 | CAS number: 6420-33-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 October 1985 to 1 November 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
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:
- Tetrasodium 3,3'-[carbonylbis[imino(5-methoxy-2-methyl-4,1-phenylene)azo]]bis(naphthalene-1,5-disulphonate)
- EC Number:
- 229-158-0
- EC Name:
- Tetrasodium 3,3'-[carbonylbis[imino(5-methoxy-2-methyl-4,1-phenylene)azo]]bis(naphthalene-1,5-disulphonate)
- Cas Number:
- 6420-33-3
- Molecular formula:
- C37H28N6Na4O15S4
- IUPAC Name:
- tetrasodium 3-({4-[({4-[(4,8-disulfonato-2-naphthyl)diazenyl]-2-methoxy-5-methylphenyl}carbamoyl)amino]-5-methoxy-2-methylphenyl}diazenyl)naphthalene-1,5-disulfonate
- 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:
- TEST ANIMALS
- Source: by Nottingham UnÍversity, School of Agriculture, Sutton BonÍngton, Leicestershire, U.K
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.36-3.36 kg
- Housing: individually
- Diet: Rabbit Diet, A.l.l. Tindall Limited, Holbeach, Lincolnshire UK ad libitum
- Water:. ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21 °C
- Humidity (%): 45-58%
- Air changes (per hr): ca 15/hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patch wrapped with adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with water moistened cotton wool and thereafter with ether
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS: at 1 hour 24, 48 and 72 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- no irritant effects
- Other effects:
- faint yellow staining of the skin was observed, that did not prevent erythema scoring
Any other information on results incl. tables
| Animal | 1 | 2 | 3 | |||||||||
| 1 | 24 | 48 | 72 | 1 | 24 | 48 | 72 | 24 | 48 | 72 | ||
| erythema | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| oedema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritant to the skin
- Executive summary:
In a test according to OECD 404 3 rabbits were exposed dermally to the substance under semi-occlusion for 4 hours. No signs of irritation were observed at the 1, 24, 48 and 48 hour observations. A slight yellow staining of the skin was seen. The substance is not irritant to the skin.
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