Registration Dossier

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:
other: The study has been performed under GLP and in compliance with guideline

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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:
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.
Body weight:
No effect
Gross pathology:
No effect
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (dermal) > 2000 mg/kg. No clinical signs of toxicity
Executive summary:

The dermal LD50 in the rabbit is > 2000 mg/kg. No clinical signs observed.