1,3-propanesultone

Acute Toxicity: dermal

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

Test material information

Constituent 1

Reference substance name:

1,3-propanesultone

EC Number:

214-317-9

EC Name:

1,3-propanesultone

Cas Number:

1120-71-4

Molecular formula:

C3H6O3S

IUPAC Name:

1,2λ⁶-oxathiolane-2,2-dione

Test animals

Species:

mouse

Strain:

other: CFI

Sex:

male/female

Details on test animals or test system 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