Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
no
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): Crude cyanuric acid
- Lot/batch No.: Lot 3-30-81

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, MA. USA.
- Weight at study initiation: Males: 249 – 276 g; females: 181 – 202 g




Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: tap water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 397 mg/mL
- Amount of vehicle (if gavage): males ~0.7 ml; females ~0.5 ml

DOSAGE PREPARATION: The test material was ground into a powder and suspended in tap water at a concentration of 397 mg/ml.
Doses:
5000 mg/kg bw by gavage
No. of animals per sex per dose:
10 (5 male and 5 female)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations 3 times within the first 8 hours and twice daily thereafter. Body weights recorded on day 0, 7 and 14.
- Necropsy of survivors performed: yes(day 15)
Statistics:
None applied

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortalities occured
Clinical signs:
Clinical abnormalities were observed in 2 animals, one of each sex, including lack of faecal material in both animals and sedation, ataxia and piloerection, porphyrin around the nose . With the exception of body weight loss these effects subsided by the 4th day after dosing.
Body weight:
Body weight loss were observed in the male
Gross pathology:
No effects noted

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Cyanuric acid is not classified