Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

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

Test material

Constituent 1

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: sesam oil (DAB 10)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal skin
- 6x8 cm
- Type of wrap if used: aluminium foil


REMOVAL OF TEST SUBSTANCE
- Washing with warm water


Duration of exposure:
24 h
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
male: 2000 mg/kg body weight; number of animals: 5; number of deaths: 0;
female: 2000 mg/kg body weight; number of animals: 5; number of deaths 0;
Clinical signs:
other: Signs of toxicity related to dose levels: No mortalities occurred during the entire study. Symptoms were not observed either.
Gross pathology:
No macroscopically visible effects were determined during the post-mortem examination of the animals killed at the end of the study.
Other findings:
No signs of irritation were determined.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The registration substance is of low acute dermal toxicity.
Executive summary:

The registration substance was investigated for its acute dermal toxicity according to the OECD Guideline 402. Five male and five female rats were dermally treated with the registration substance at dose of 2000 mg/kg. No effect was found. The registration substance is of low acute dermal toxicity.