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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other information
Study period:
from September to October 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
- 3 instead of 5 animals/sex used
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
17-hydroxy-3-methoxyestra-2; 5(10)-diene-17-carbonitrile
IUPAC Name:
17-hydroxy-3-methoxyestra-2; 5(10)-diene-17-carbonitrile
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals

Species:
rat
Strain:
other: Shoe:Wist
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: 0.9 % sodium chloride solution
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

At 2000 mg/kg no compound-related clinical findings were observed. Two male and one female rat showed a body weight loss in week 1. In addition, one of the two male rats showed a reduced body weight gain throughout the study period, when compared to the 90% range of historical reference data used in our laboratory. Autopsy revealed no compound-related findings. No animal died in the course of the study.

Applicant's summary and conclusion

Executive summary:

The acute dermal toxicity of the test substance was low with a LD50 value exceeding 2000 mg/kg bw in rats according to OECD TG 402. At the limit-dose 2000 mg/kg no animal died, no clinical findings, slight efffects on body weight gain and no gross pathological findings were observed during the 14-day post observation period.