1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

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: 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

Test material information

Constituent 1

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 levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 400 - < 800 mg/kg bw

Based on:

test mat.

Effect levels 2

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