Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline study with acceptable restrictions (pregnant rats used; partly limited documentation, e.g. no details about doses).

Data source

Reference
Reference Type:
publication
Title:
Embryotoxicity in rats and rabbits from cutaneous application of amide-type solvents and substituted ureas
Author:
Stula EF, Krauss WC
Year:
1977
Bibliographic source:
Toxicol Appl Pharmacol 41: 35-55

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Approximate lethal dose procedures
Deviations:
no
GLP compliance:
no
Test type:
other: Approximate lethal dose procedures
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity >=98%
no further details

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
primigravida rats, 220-250 g bw

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
One animal used per dose level; rats were treated on gestation day 11
Duration of exposure:
unwashed
Doses:
dose level with a factor of 1.5 between dose levels
no further details
No. of animals per sex per dose:
1 female
Control animals:
not required
Details on study design:
animals sacrificed gestation day 20.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
other: approximate lethal dose
Effect level:
11 000 mg/kg bw
Remarks on result:
other: pregnant rats

Any other information on results incl. tables

No further details were presented.

Applicant's summary and conclusion

Conclusions:
In pregnant Sprague-Dawley rats the approximate lethal dose was 11000 mg/kg bw after dermal exposure.
Executive summary:

Comparable to Guideline study with acceptable restrictions (pregnant rats used; partly limited documentation, e.g. no details about doses).

The approximate lethal dose in pregnant Sprague-Dawley rat was determined. One rat per dose level received dermal application (coverage: open) at gestation day 11. The post exposure period was 9 days.

Conclusion: In pregnant Sprague-Dawley rats the approximate letal dose was 11000 mg/kg bw after dermal exposure.