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:
comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VI
Author:
Smyth H.F.; Carpenter, C.P.; Weil C.S.; Pozzani, U.C.; Striegel, J.A.
Year:
1962
Bibliographic source:
American Industrial Toxicity Data: List VI 23: 95 - 107
Reference Type:
secondary source
Title:
American Industrial Hygiene Association
Year:
1962
Bibliographic source:
http://www.safe.nite.go.jp/english/ghs/11-mhlw-0074e.html Original source: American Industrial Hygiene Association Journal. Vol. 23, Pg. 95, 1962.

Materials and methods

GLP compliance:
no
Test type:
standard acute method

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
2.5-3.5 kg body weight

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film.
The animals are immobilized during the 24-hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14-day observation period.
Duration of exposure:
24 h
Doses:
Dosages greater than 20 ml/kg cannot be retained in contact with the skin.
No. of animals per sex per dose:
4
Control animals:
not specified
Statistics:
Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson using the tables of Weil.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
0.071 mL/kg bw
Remarks on result:
other: equivalent to 84.4 mg/kg bw
Mortality:
Not specified
Clinical signs:
Not specified
Body weight:
Not specified
Gross pathology:
Not specified

Applicant's summary and conclusion

Interpretation of results:
Category 2 based on GHS criteria