Registration Dossier
Registration Dossier
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EC number: 201-248-4 | CAS number: 80-08-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Dapsone
- EC Number:
- 201-248-4
- EC Name:
- Dapsone
- Cas Number:
- 80-08-0
- Molecular formula:
- C12H12N2O2S
- IUPAC Name:
- 4,4'-sulfonyldianiline
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
- Details on test material:
- 1% dapsone gel, formula #05/44-1, lot # 020-97
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back of the animal (shaved)
- Type of wrap if used: polyethylene plastic
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2g/kg bw
- Constant volume or concentration used: yes/no no
- For solids, paste formed: yes, 1% in a gel paste - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Each 5 males and 5 females
- Control animals:
- not required
- Details on study design:
- Ten rabbits (5 per gender) were used. The back of each animal was haved. Half the animals received epidermal abrasions on the shaved area. The test article (1% dapsone gel) was applied to the back of each animal at a dose of 2g/kg and covered with polyethylene plastic. The rabbits were fitted with collars and the test article was left in place for 24 hours. The test sites were then wiped clean and the rabbits were monitored for 14 days for signs of illness, mortality,, and dermal reactions (erythema and edema) at the site of application. Body weights were recorded at the time of dosing and after 14 days.
Results and discussion
- Preliminary study:
- Very slightly (barely perceptible) erythema was observed for the first 7 to 12 days after treatment; this may have been due to shaving, occlusion, taping, etc. No edema was observed. No effects on body weight, survival, clinical signs, or gross necropsy were observed.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- None
- Clinical signs:
- other: Very slightly (barely perceptible) erythema was observed for the first 7 to 12 days after treatment; this may have been due to shaving, occlusion, taping, etc. No edema was observed.
- Gross pathology:
- No effect
- Other findings:
- No effects on body weights
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose by dermal route in NZW rabbits (LD50) was > 2000 mg/kg.
- Executive summary:
An acute dermal toxicity study is available in the Norman A. See, Pharmacology review (2005). The study was conducted in compliance with gool laboratory practice in 1997. Ten New Zealand white rabbits (5 per gender) were used. The back of each animal was shaved. Half the animals recieved epidermal abrasions on the shaved area. The test article (1% dapsone gel) was applied to back of each animal at a dose of 2g/kg and covered with polyethylene plastic. The rabbits were fitted with collars and the test article left in place for 24 hours. The test sites were then wiped clean and the rabbits were monitored for 14 days for signs of illness, mortality and dermal reactions (erythema and edema) at the site of application. Body weights were recorded at the time of dosing and after 14 days.
Very slight erythma was observed for the first 7 to 12 days after treatment; this may have been due to shacing, occlusion, taping, etc. No edema was observed. No effects on body weight, survival, clinical signs or gross necropsy were observed.
Under the conditions of this study, the test article did not appread to induce toxicity.
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