Registration Dossier
Registration Dossier
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EC number: 213-834-7 | CAS number: 1025-15-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- EC Number:
- 213-834-7
- EC Name:
- 1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- Cas Number:
- 1025-15-6
- Molecular formula:
- C12H15N3O3
- IUPAC Name:
- tris(prop-2-en-1-yl)-1,3,5-triazinane-2,4,6-trione
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crj:CD(SD)IGS
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 weeks
- Weight at study initiation: males average: 219 g (range: 208 - 238 g), females average: 154 g (range: 138 - 173 g)
- Fasting period before study: 16 hours before administration
- Housing: in the metal bracket type cage
- Diet (e.g. ad libitum): CRF-1 (Oriental Yeast Co., Ltd., Itabashi-ku, Japan) ad libitum
- Water (e.g. ad libitum): tap-water, ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
-according to guideline
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
- Doses:
- 250, 500, 1000 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 0, 1, 2, 3, 7, 10 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology and histopathology - Statistics:
- VanWaerden test for LD50;
Bartlett and Dunett test for analysis of body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 707 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 812 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 619 - 1 066
- Mortality:
- 250 mg/kg bw and 500 mg/kg bw: No mortality was observed.
1000 mg/kg bw (males): 5/5 males died; one death occured at day 3, three deaths at day 4 and one death at day 5 after administration.
1000 mg/kg bw (females): 4/5 females died; two deaths occured at day 3, one death at day 4 and one death at day 5 after administration.
2000 mg/kg bw (males): 5/5 males died; four deaths occured at day 3 and one death at day 5 after administration.
2000 mg/kg bw (females): 5/5 females died; one death occured at day 1, two deaths at day 2 and two deaths at day 3 after administration. - Clinical signs:
- other: 250 mg/kg bw and 500 mg/kg bw: No abnormalities were observed in both sexes. 1000 mg/kg bw: In the animals that died, reduced locomotor activity, staggering gait, tremors, clonic convulsions, mydriasis, smudging in the peri-genitourinary area or hypotherm
- Gross pathology:
- 1000 mg/kg bw and 2000 mg/kg bw: Necropsy of animals that died revealed malnutrition, a smaller thymus and spleen, smaller mesenteric lymph nodes, dark red foci in the glandular stomach and white foci in the forestomach. In the surviving female of the 1000 mg/kg bw dose group white foci in the forestomach
were seen.
500 mg/kg bw: Necropsy revealed white foci in the forestomach in one female rat. - Other findings:
- Histopathology:
Mild to moderate erosion/ulceration and thickening of mucosal epithelium in the forestomach was observed in one male and one female administered 1000 mg/kg bw and in two males administered 2000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- A single dose oral toxicity test of triallyl isocyanurate in rats revealed LD50 values of 707 mg/kg bw for males and 812 mg/kg bw for females.
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