Registration Dossier
Registration Dossier
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EC number: 432-520-2 | CAS number: 232938-43-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 432-520-2
- EC Name:
- -
- Cas Number:
- 232938-43-1
- Molecular formula:
- C21 H20 N2 O6 S2
- IUPAC Name:
- 3-{[(4-methylbenzenesulfonyl)carbamoyl]amino}phenyl 4-methylbenzene-1-sulfonate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 14 weeks (males), 15 weeks (females)
- Mean weight at study initiation: 2804 g
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet
- Water (e.g. ad libitum): Community tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24 °C
- Humidity (%): 48-88 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: untreated skin of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mg
VEHICLE
- Amount(s) applied (volume or weight with unit): moistened with water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 1 male,
2 females - Details on study design:
- TEST SITE
- Area of exposure: flank
- % coverage: 10 cm x 10 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water
- Time after start of exposure: 4h
SCORING SYSTEM: numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992
Results and discussion
In vivo
Resultsopen allclose all
- 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
- 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 #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 #3
- 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 #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - Application of the test article to healthy intact rabbit skin resulted in a primary irritation score of 0.00.
- Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No signs of irritation were observed.
- No staining by the test article of the treated skin was observed. - Other effects:
- - No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
- Animals gained normal body weight.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating according to EC regulation 1272/2008 and its amendments.
- Conclusions:
- After dermal application of 0.5 mg test substance according to OECD guideline 404 for 4 h skin was flushed with water and the skin was scored for erythema and edema after 24, 48 and 72 h. Since neither erythema nor edema were seen the test substance is considered to be "not irritating" to rabbit skin.
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