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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:
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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1962
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 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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
No clinical symptoms of toxicity were observed
Body weight:
Groupwise body weight at test initiation: 2520 g
Groupwise body weight at the end of the 14 day-observation period: 2570 g
The reduced groupwise body weight gain was related to 2 of the 4 animals that had a reduction in body weight gain (no further data available).
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