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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Jul 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well reported GLP study with acceptable restrictions

Data source

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

Materials and methods

Principles of method if other than guideline:
combined acute dermal toxicity and local irritation study; single dermal application of test substance (application volume 0.4 - 0.6 ml; 439-587 mg/animal) to male and female rats; exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained 1 h after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
5-Hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androst-6-en-17-one
EC Number:
617-345-3
Cas Number:
82543-14-4
Molecular formula:
C25 H36 O4
IUPAC Name:
5-Hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androst-6-en-17-one
Details on test material:
- Name of test material (as cited in study report): ZK 90504
- Batch No.: 21608604

Test animals

Species:
rat
Strain:
Wistar

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
water
Remarks:
bidest. water
Controls:
no
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
3/sex

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Other effects:
No mortalities or macroscopic pathological signs were observed. Shortly after administration females showed some clinical signs such as hyperactivity, vocalization and spastic gait. No compound-related clinical signs were observed in females from 3 hours after administration onwards, males were without findings over the whole study period.

Applicant's summary and conclusion

Executive summary:

The single dermal administration of Enpivalat to male and female rats at a dose of 2000 mg/kg (application volume 0.4 - 0.6 ml; 439-587 mg/animal) was tolerated without any mortality or macroscopic pathological signs. Shortly after administration females showed some clinical signs such as hyperactivity, vocalization and spastic gait. No compound-related clinical signs were observed in females from 3 hours after administration onwards, males were without findings over the whole study period. The test substance was tolerated without any local skin irritations.

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