Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 27 – September 17, 1998
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Characteristics: powder
Storage conditions: at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Number and sex of animals: 5 males + 5 females treated at 2000 mg/kg
Body weight (at randomization): Males 295-350 g; Females 231-271 g
Age (at randomization): not more than three months
Acclimatation: more than 5 days before the start of the test. Animals were observed daily to ascertain their fitness for the study.
Animal identification: by appropriately coloring different areas of the limbs. Cage card gave experiment number, dosage group, sex and date of administration.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: 0.9% NaCl
Details on dermal exposure:
Preparation of animals skin: approximately 24 hours before the test, fur was clipped from the dorsal and ventral area of the trunk of the test animals. Care was taken to avoid abrading the skin which could alter its permeability. An area of about 6x5 cm of the body dorsal surface was cleared for the application of the test article. This area corresponded to about 10% of the total body surface.

Administration of the test article: the test article which was applied uniformly by gentle inunction onto a porous gauze which was moistened with 0.9% NaCl. The treated area was covered with the porous gauze dressing fixed to the skin with hypoallergenic non irritating tape. The test site was further covered in a suitable manner in order to ensure that the animals could not ingest the test substance. At the end of the exposure period the residual test article was wiped off with water.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
One group of 5 rats/sex was administer a dosage of 2000 mg/kg of the test article.
Control animals:
yes
Details on study design:
Observation period: 14 days after the 24 hour exposure period.
Observation of clinical signs and mortality: at 30 minutes, 2,4 and 6 hours on the first day after the administration and then twice a day up to termination of the observation period.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no animals died during the study. The LD50 was not calculated and it was considered higher than 2000 mg/kg
Clinical signs:
No general or local clinical abnormalities were seen in any animal
Body weight:
Body weights of both males and females were found to be unaffected by the test article administration.
Gross pathology:
No appreciable changes were evident in the treated animals of either sex at the autopsy carried out at the end of the observation period.

Any other information on results incl. tables

The day of treatment was considered day 1 of the study. The animals were weighed twice before treatment and on day 8 and 15. They were clinically observed for 14 days after the 247 hour exposure period. On day 16 all rats were killed by excision of the femoral arteries after i.p. overdosage anesthesia with 5% sodium pentobarbital and submitted to a thorough autopsy.

No animals died and no general or local clinical signs were observed in any treated rat during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article, when administered by dermal route to the rat, did not cause mortality or show important toxic effects at the limit dose of 2000 mg/kg. The LD50 by dermal route is higher than 2000 mg/kg.