Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline study with acceptable restriction (report not available for submitter; presumably evaporation of the test substance; clinical signs not recorded daily, 2 animals [but no toxicity reported]; no further details available)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Methyl vinyl ether (MVE), no further information

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
Animals were kept in rooms designed to maintain adequate environmental conditions, and were given a commercial diet and municipal water ad libitum.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
One male and one female New Zealand White Rabbit were subjected to 24 hours of contact with the undiluted, cold test material (not specified further), retained under occlusive dressings on clipped, intact skin of the animals' trunk.
Duration of exposure:
24 h
Doses:
8 ml/kg bw
No. of animals per sex per dose:
1
Control animals:
not required
Details on study design:
The animal was returned to the home cage for the 24 hour contact period. Excess test material was removed after the contact period to diminish ingestion. Observations for skin reactions were made at one hour, 7 days, and 14 days.
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 mL/kg bw
Remarks on result:
other: ca. 5000 mg/kg bw
Mortality:
no
Clinical signs:
no systemic clinical signs; local effects: light brown sample stain at 1-14 days,erythema and edema at 1st day.
Body weight:
no data
Gross pathology:
no gross lesions

Any other information on results incl. tables

The recommended limit dose according to OECD TG402 is 2000 mg/kg bw.

Applicant's summary and conclusion

Conclusions:
No systemic clinical signs and no mortality were reported after 24 h occlusive exposure to 8 mL/kg bw (ca. 5000 mg/kg bw; cold liquid; recommended limit dose according to OECD402 is 2000 mg/kg bw) in two New Zealand White rabbits; the acute dermal LD50 is > 5000 mg/kg bw.