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 restrictions. Restriction: purity of test substance not stated; no data on clinical signs; no necropsy; only males.

Data source

Reference
Reference Type:
publication
Title:
Range-finding toxicity data: List VI
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani U, Striegel JA
Year:
1962
Bibliographic source:
Am Ind Hyg Assoc J 23: 95-107

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
isobutyl vinyl ether (IBVE), no further data

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
Male albino New Zealand rabbits weighing 2.5 to 3.5 kg were used.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Groups of 4 animals were used. Dosages up to 20 mL/kg bw were placed on the shaved rabbit skin under occlusive dressing. The animals were immobilized during the 24 hour contact period.
Duration of exposure:
24 h
Doses:
up to 20 mL/kg bw (corresponding to 15400 mg/kg bw)
No. of animals per sex per dose:
4
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no
- no data about clinical signs & body weight
Statistics:
LD50-values were estimated by the method of Thompson using the tables of Weil, based on mortalities noted during the 14-day observation period.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
15 400 mg/kg bw
Remarks on result:
other: corresponding to 20 mL/kg bw

Any other information on results incl. tables

No further data available.

Applicant's summary and conclusion

Conclusions:
In male New Zealand White rabbits the dermal LD50 was 20 mL/kg bw corresponding to 15400 mg/kg bw. The recommended limit dose according to OECD TG402 is 2000 mg/kg bw.