Registration Dossier
Registration Dossier
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EC number: 419-800-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 419-800-1
- EC Name:
- -
- Cas Number:
- 112101-81-2
- Molecular formula:
- C10H16N2O3S
- IUPAC Name:
- (R)-5-(2-Aminopropyl)-2-methoxybenzenesulfonamide
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:NZW/Kbl(BR)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Manston.
- Age at study initiation: Fourteen to sixteen weeks old
- Weight at study initiation: 2.7 to 2.94 Kg
- Housing: Single floow pens with a minimum area of 0.6 sq m.
- Diet (e.g. ad libitum): SQC standard rabbit diet (pelleted) was freely available at all times.
- Water (e.g. ad libitum): Mains water provided ad libitum via water bottles.
- Acclimation period: At least 1 month
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 22°C
- Humidity (%): 40 to 80%
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): Twelve hours light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg spread uniformly over the designated area. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Not less than 3 days
- Number of animals:
- 3 males (1 sentinel followed by 2 additional animals)
- Details on study design:
- TEST SITE
- Area of exposure: 30 x 20 mm
- Type of wrap if used: Area covered by a dense gauze patch which in trun was covered by a larger gauze patch and an open weave elasticated adhesive bandage firmly wrapped around the torso.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated areas of the skin were swabbed with moist cotton wool.
- Time after start of exposure: Straight away after the 4 hour exposure period.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 hours after patch removal
SCORING SYSTEM:
- Method of calculation: Standard as per OECD guidelines.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There were no dermal changes or irritation reactions at sites of application of the test substance.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single semi-occluded application of the test substance to intact rabbit skin for 4 hours did not elicit any dermal changes or irritation reactions.
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