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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
THE CARCINOGENIC RESPONSE IN MICE TO THE TOPICAL APPLICATION OF PROPANE SULTONE TO THE SKIN
Author:
Doak, S.M.A. et al.
Year:
1976
Bibliographic source:
Toxicology 6, 139-154

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
-The test solutions and solvents were applied to the skin with fine brushes (one application of 25% w/v propane sultone in toluene)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
other: CFI
Sex:
male/female
Details on test animals and environmental conditions:
- mice were bred in specific pathogen- free conditions at Tunstall Laboratory
- six weeks of age at the beginning of treatment
- water and cubed 86S diet (obtained from Grain Harvesters, Wingham, Kent) were provided ad libitum
- mice were individually housed

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: toluene
Details on dermal exposure:
- the hair on the back was shorn with fine electric clippers before treatment started
- the test solution (0.1 mL) was applied to the dorsal skin using all-glass syringes
Duration of exposure:
- one single application
Doses:
- 25% (w/v) = 25 mg/mouse corresp. to 830 mg/kg bw
No. of animals per sex per dose:
- 48
Control animals:
yes
Details on study design:
The occurence of lethality was observed daily.
Each animal was examined weekly and the size, appearance and position of all skin lesions were recorded.
After 78 weeks, the mice were killed and subjected to a detailed necropsy and a histological examination of skin and the major viscera for the presence of neoplasms. Similar examinations were carried out on animals dying or killed because of ill-health during the experiment, with the exception of those not surviving beyond the first 7 days after exposure.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: LD15
Effect level:
830 mg/kg bw
Based on:
test mat.
Remarks on result:
other: - during the first 4 days of the study, 12 males and 2 females died (group size: 48 mice each)
Mortality:
- 12 males and 2 females died after 4 days

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification