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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (e.g. only range finding test, no official guideline applicable)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- range finding test for repeated dose tests, 5 days, daily oral application via gavage, 6 dose groups with 5 male and 5 female rats each plus control goup
- according to standing operation procedure of testing laboratory
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
other: Charles River CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc. , Portage, Michigan
- Age at study initiation: approximately 5 weeks old
- Weight at study initiation: 173 - 194 g (males), 127 - 142 g (females)
- Fasting period before study: none
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: mineral oil
Details on oral exposure:
PREPARATION OF DOSING SOLUTIONS:
- weighing and suspending of test substance in vehicle (mineral oil) with a tissue homogenizer with pestel
- transfer of the mixture to a graduated mixing cylinder and addition of the respective amount of vehicle and homogenization by manual shaking of cylinder


VEHICLE
- Justification for use and choice of vehicle: none stated in report, but the test item is known to hydrolyze rapidly in water
- Concentration in vehicle: 10 - 320 g/L
- Amount of vehicle: 1 mL/kg
- Lot/batch no.: not reported, supplier: American Drug Industries; Inc. ; Chicago, Illinois, USA
- Purity: not reported
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
5 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 10, 20, 40, 80, 160, 320 mg/kg
Basis:
other: nominaly via gavage
No. of animals per sex per dose:
5
Control animals:
other: vehicle (mineral oil)
Details on study design:
- Dose selection rationale: none stated
- Rationale for animal assignment: random
Positive control:
- none

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily


DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily


BODY WEIGHT: Yes
- Time schedule for examinations: day 0 and day 5


FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes

Sacrifice and pathology:
GROSS PATHOLOGY: Yes

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Gross pathological findings:
effects observed, treatment-related

Effect levels

Dose descriptor:
NOAEL
Effect level:
10 other: mg/kg
Based on:
test mat.
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The present study was conducted following no official guideline. Charles River CD rats were treated on 5 consecutive days with cyanuric chloride in mineral oil via gavage. No systemic toxicity was found. Effects are only seen at the portal of entry based on the irritation and caustic effects of cyanuric chloride. A NOAEL for subacute oral toxicity of 10 mg/kg bw/day was deduced under the test conditions.