Registration Dossier
Registration Dossier
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EC number: 611-210-2 | CAS number: 54914-95-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets scientific standards with acceptable restrictions (limited documentation, unusual test periods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 960
- Report date:
- 1960
Materials and methods
- Principles of method if other than guideline:
- Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5 and 15 minutes and two other animals for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the powdered and moistened test substance.
- GLP compliance:
- no
Test material
- Reference substance name:
- sodium 2-amino-5-methylbenzenesulfonate
- EC Number:
- 611-210-2
- Cas Number:
- 54914-95-3
- Molecular formula:
- C7 H8 N O3 S Na
- IUPAC Name:
- sodium 2-amino-5-methylbenzenesulfonate
- Details on test material:
- - Name of test material (as cited in study report): Natriumsalz der 4-Toluidin-3-sulfosaeure (sodium salt, pure, solid)
- Analytical purity: no data, pure
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.0 - 3.11 kg
ENVIRONMENTAL CONDITIONS
not reported
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 50%
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 ml - Duration of treatment / exposure:
- Experiment 1: 1, 5, or 15 minutes
Experiment 2: 20 h - Observation period:
- up to 12 days
- Number of animals:
- 2 per experiment
- Details on study design:
- TEST SITE
- Area of exposure: An application site of 2.5 X 2.5 cm was covered with the liquid (37°C; approx. 1 ml)
REMOVAL OF TEST SUBSTANCE
- Washing:
Experiment 1: washing was done in the 1 min, 5 min and 15 min test directly after exposure. Lutrol 50% (mild detergent) was used.
Experiment 2: No washing was done after the 20 h treatment.
SCORING SYSTEM
Descriptive scores have been converted into OECD/ Draize scoring system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 20 h exposure
- Time point:
- other: 24 - 48 h (no reading after 72 h)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: The application area was coloured blueish at the 24 hrs reading ; no further effects were observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 20 h exposure
- Time point:
- other: 24 - 48 h (no reading after 72 h)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 15 min
- Time point:
- other: 24 - 48 h (no reading after 72 h)
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: 1/2 animals was completely free from effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 15 min
- Time point:
- other: 24 - 48 h (no reading after 72 h)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 5 min
- Time point:
- other: 24 - 48 h (no reading after 72 h)
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: 1/2 animals was completely free from effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 5 min
- Time point:
- other: 24 - 48 h (no reading after 72 h)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 1 min
- Time point:
- other: 24 - 48 h (no reading after 72 h)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 1 min
- Time point:
- other: 24 - 48 h (no reading after 72 h)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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