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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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 .