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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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals 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:
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, discolored red haircoat on the nose, discolored red skin on the front feet, hunched appearance, squinting eyes, rough haircoat, cold to the touch (entire body), and/or general debilitation.
These findings were most likely related to treatment with the test article.
Body weight:
Administration of the test article had no effect on body weight for animals given 400 or 800 mg/kg.
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