17-hydroxy-3-methoxyestra-2,5(10)-diene-17-carbonitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

other information

Study period:

from September to October 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Comparable to guideline study with acceptable restrictions: A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion. The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint.

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:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

- exposure time 24 hrs instead of 4 hrs, 6 animals instead of 3, few details in test description and reporting

Test material

Test material information

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

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

other: 0.9 % sodium chloride solution

Controls:

other: the untreated skin served as control

Amount / concentration applied:

549-613 mg/male animal or 420-440 mg/female animal

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

3 males and 3 females

Results and discussion

Any other information on results incl. tables

No relevant compound-related local findings were observed. The only finding was the occurrence of substance remains in male rats up to day 4, with the distribution ranging from spotty to covering the whole administration area.

The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.

Applicant's summary and conclusion

Executive summary:

A combined study on acute dermal toxicity and on local tolerance was conducted . The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of skin irritation/corrosion. In this studya single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg was tolerated without any local irritations.