1,3,5-trioxane

Acute Toxicity: dermal

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: Study well documented with generally accepted scientific principles, acceptable for assessment.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1962

Reference 2

Reference Type:

secondary source

Title:

1,3,5-TRIOXANE, CAS Number 110-88-3, USEPA HPV Challenge Program Submission

Author:

Trioxane Manufacturers Consortium Members, BASF Performance Copolymers, LLC (Formerly Ultraform Company) and Ticona.

Year:

2000

Bibliographic source:

USEPA HPV Submission

Reference 3

Reference Type:

publication

Title:

Range-finding toxicity data for 43 compounds.

Author:

Rinehart, W.E., Kaschak, M., Pfitzer, E.A.

Year:

1967

Bibliographic source:

Ind. Hyg. Found. Am. Chem. Toxicol. Ser. Bull., 6:1-11.

Materials and methods

Principles of method if other than guideline:

The acute dermal toxicity was determined in male rabbits according to the Federal Hazardous Substance Labeling Act provisional guidelines FR 8/12/1961

GLP compliance:

no

Remarks:

; GLP was not compulsory at the time the study was conducted

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3,5-trioxane

EC Number:

203-812-5

EC Name:

1,3,5-trioxane

Cas Number:

110-88-3

Molecular formula:

C3H6O3

IUPAC Name:

1,3,5-trioxane

Details on test material:

- Name of test material (as cited in study report): Trioxane
- Physical state: Clear colorless crystalline material

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.4-2.7 Kg
- Acclimation period: 7 days

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Prior to exposure, the animals were prepared by clipping the skin of the trunk, which is approximately 10% of the body surface, free of hair. One-half of each group was further prepared by making epidermal abrasions every two or three centimeters longitudinally over the area of future exposure.
- The material was evenly distributed on cotton gauze moistened with physiological saline solution. The gauze and material were applied to the skin of the rabbits and the entire trunk was wrapped in an impervious plastic film.

Duration of exposure:

24 hours

Doses:

3980 mg/kg bw

No. of animals per sex per dose:

4

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 3 980 mg/kg bw

Mortality:

No mortality observed

Clinical signs:

other: No clinical symptoms of toxicity were observed

Gross pathology:

Necropsy was inconspicuous

Other findings:

Skin irritation:
After removal of the wrap, very slight to moderate erythema was seen, but no appreciable edema. The finding disappeared within 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information