Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23. Feb to 22. March 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
3 rats/sex and dose group
Principles of method if other than guideline:
According to Schlede et.al., A national validation study of the acute-toxic-class method - an alternative to the LD50 test, Arch. Toxicol. 66, 7, 1992, 455-470.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4-Androstene -3,17- dione
- Lot/batch No.: JC9410
- Stability under test conditions: The formulation was freshly prepared on application day.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: HAN: WIST (SPF)
- Source: Schering AG
- Age at study initiation: not reported
- Weight at study initiation: males 106-112 g, females 101-111 g
- Fasting period before study: about 18.5 h
- Housing: singly in conventional housing conditions
- Diet and water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 54-62
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: 0.9 % saline solution
Details on dermal exposure:
212-224 mg/male rat; 208-222 mg/female rat
The test substance was formulated with 0.9 mL physiological saline solution and then applied as a paste onto the skin.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs several times on day 1 and at least once daily throughout the rest of the study. Body weights were determined at study start (day 1), on day 7 and at termination of the study (day 14).
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No animal died in the course of the study.
Clinical signs:
No compound-related clinical signs were observed.
Body weight:
The body weight gain observed on days 7 and 14 was within the normal range for male or female rats of this age and strain compared to historical data.
Gross pathology:
Autopsy revealed no compound-related findings.

Applicant's summary and conclusion

Conclusions:
No classification required for acute dermal toxicity according to Directive 67/548/EEC and Regulation (EC) 1272/2008.
Executive summary:

The single dermal administration of 2000 mg/kg to male and female rats was tolerated without compound-related clinical signs or effects on body weights during the 14 -day observation period. At necropsy no compound-related findings were detected. Thus, the LD50 for acute dermal toxicity was concluded to be above 2000 mg/kg bw.