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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
July to Nov 2006
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:
2009
Report date:
2009

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, few details in test description and reporting
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
17 alpha-Cyanomethyl-17 ß-hydroxy-5(10)-estren-3-one
IUPAC Name:
17 alpha-Cyanomethyl-17 ß-hydroxy-5(10)-estren-3-one
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals

Species:
rat
Strain:
Wistar

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
physiological saline
Controls:
other: the untreated skin served as control
Amount / concentration applied:
566-580 mg / male animal or 417-436 mg / female animal (= 2000 mg/kg bw)
Duration of treatment / exposure:
24 hours
Observation period:
21 days
Number of animals:
3 males and 3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation

Any other information on results incl. tables

No compound-related findings were observed at the dose of 2000 mg/kg. 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 for swelling, reddening and scab formation.

Applicant's summary and conclusion

Executive summary:

A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg (566-580 mg/male or 417-436 mg/ female) was tolerated without any local irritations. 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 for swelling, reddening and scab formation.