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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Strain: Sprague-Dawley (SPF) ; 5 /sex – 1 treated group
- Age/Bodyweight at start: 9-week old; 294 +/-5g (males); 221+/-6g (females)
- Temperature: 22+/-2°C; RH: 30-70%; Light/dark cycle: 12h/12h; ventilation: Approx. 12 cycles/h
- Caging: 1 rat/sex/cage, on stainless steel lids
- Food and water ad libitum

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
- application on dorsal clipped area (approx. 10% of body surface)
- test item moistened with purified water
- test item held in contact with the skin for 24h by a gauze pad and hypoallergenic aerated semi-occlusive adhesive dressing
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
- 2-week observation period after dosing
- monitoring: clinical signs (incl. cutaneous reactions) and mortality, bodyweight
- terminal kill on Day 15: macroscopic examination

Results and discussion

Preliminary study:
Not applicated.
Effect levels
Sex:
male/female
Dose descriptor:
other: mortality
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality.
Clinical signs:
None (incl. cutaneous reactions).
Body weight:
Transient body weight loss in 2/5 females.
Gross pathology:
No macroscopic abnormality.
Other findings:
None.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Lethal dose > 2000mg/kg via dermal application .