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Toxicological information

Acute Toxicity: oral

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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: according to OECD guideline and GLP compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
EC Number:
219-514-3
EC Name:
1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
Cas Number:
2451-62-9
Molecular formula:
C12H15N3O6
IUPAC Name:
tris[(oxiran-2-yl)methyl]-1,3,5-triazinane-2,4,6-trione

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Hollister, California
- Age at study initiation: 8 weeks old (Group 1), 10 weeks old (Group 2)
- Weight at study initiation: 171 to 185 g for the females and 229 to 240 g for the males (Group 1), 229 to 246 g for the females and 331 to 356 g for the males (Group 2)
- Fasting period before study: Animals were fasted overnight from 17 to 20 hours
- Housing: housed individually in polycarbonate cages with bedding
- Diet (e.g. ad libitum): Certified Rodent Diet #2016C (Harlan Laboratories, Inc.)
- Water (e.g. ad libitum): water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 26 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): 10 or greater
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
Group 1 received a single dose at a dose level of 400 mg/kg.
Group 2 received a single dose at a dose level of 800 mg/kg.
Doses:
400 and 800 mg/kg.
No. of animals per sex per dose:
3 animals/sex/group

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 400 - < 800 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
other: NOEL
Effect level:
ca. 400 mg/kg bw
Based on:
test mat.
Mortality:
All animals given 400 mg/kg survived to their scheduled sacrifice. All animals given 400 mg/kg were normal at each observation interval.
All males given 800 mg/kg were sacrificed in a moribund condition due to clinical observations on Day 2 of the dosing phase.
All females given 800 mg/kg were sacrificed in a moribund condition due to clinical observations on Day 4 of the dosing phase.
Clinical signs:
other: Clinical observations for males included hunched appearance, squinting eyes, rough haircoat, discolored red skin on the nose, and/or general debilitation. Clinical observations for females included intermittent tremors of the entire body, few feces, disc
Gross pathology:
No abnormal macroscopic observations were noted for animals given 400 mg/kg.
Two females given 800 mg/kg were noted with dark red discolored skin on the front feet, and one female given 800 mg/kg was noted with a large stomach. These findings are related to treatment with the test article.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Therefore, for male and female rats given triglycidyl isocyanurate as a single dose, the no observed effect level (NOEL) is 400 mg/kg. The LD50 of triglycidyl isocyanurate is between 400 and 800 mg/kg based on the conditions of this study.
Executive summary:

NOEL = 400 mg/kg

400 < LD50 < 800 mg/kg