Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 or test system 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:
other: Not specified
Gross pathology:
Not specified

Applicant's summary and conclusion

Interpretation of results:
Category 2 based on GHS criteria