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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 July - 26 August 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Directive 92/69/EEC, Method B3 Part 3;OECD Guideline No.402
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: 1% methylcellulose.
Duration of exposure:
24 h

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: No deaths occurred in any of the animals. A slight bodyweight loss was noted in two females on day 8 and day 15. One female gained no weight on day 8. No other systemic responses were observed in any animals.
Gross pathology:
Effects on organs:
No macroscopic abnormalities were observed for animals
killed at study termination on Day 15.
Other findings:
Signs of toxicity (local):
Transient slight to well-defined irritation (erythema/oedema
Grade 1 or 2) was notable in four males and four females
following removal of dressings, resolving in all instances
by Day 5. No dermal response was evident in the remaining
two rats throughout the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute lethal dermal dose to rats was demonstrated to be greater than 2000mg/kg bodyweight
Executive summary:

A study was carried out on male and female Sprague-Dawley rats to determine the acute dermal (systemic) toxicity potential for substance BMS 217947 -01, according to EU Test Method B3, Part 3 of Directive 92/69/EEC and OECD Test Guideline No 402. None of the 5 male and 5 female rats died when exposed to doses of 200 mg/kg bw and 2000 mg/kg bw. Therefore, the LD50 value for dermal exposure is greater than 2000 mg/kg bw. As a result, the substance is not classified as acute dermal toxic.