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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
Study period:
Not reported. Test material was received 12 July 1977, study report was finalised 7 December 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Five male and 5 female rats of the Charles River CD strain (obtained from Charles River Laboratories, Portage, Michigan) weighing from 200 to 211 grams, were used for this study. The rats were housed by sex in groups of 5 rats per cage, in hanging wire-mesh cages in temperature and humidity controlled quarters. They were maintained in accordance with the recommendations contained in H.E.W. Publication No. 74-23 (N.I.H.) entitled "Guide for the Care and Use of Laboratory Animals". Water and Purina Laboratory Chow were available ad libitum, except for an overnight period preceding oral administration during which food, but not water was withheld.

The test material was suspended in corn oil and administered orally by gavage at a dosage level of 10,000 mg/kg. A volume of 20 ml/kg of body weight was administered. All rats were observed for mortality and pharmacotoxic signs during the first four hours after dosing, at 24 hours and daily thereafter for a total of 14 days. Body weights were recorded initially and at 7 and 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material identified as 'Firemaster 100 Lot 53 77.902' and was received as a fine white powder.

Test animals

Species:
rat
Strain:
other: Charles River CD strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
Charles River Laboratories, Portage, Michigan.

- Age at study initiation:
Not reported.

- Weight at study initiation:
200-211 grams.

- Fasting period before study:
Yes, overnight.

- Housing:
The rats were housed by sex in groups of 5 rats per cage, in hanging wire-mesh cages in temperature and humidity controlled quarters.

- Diet (e.g. ad libitum):
ad libitum, except for fasting period.

- Water (e.g. ad libitum):
ad libitum

- Acclimation period:
Not reported.

ENVIRONMENTAL CONDITIONS
Animals were maintained in accordance with the recommendations contained in H.E.W. Publication No. 74-23 (N.I.H.) entitled "Guide for the Care and Use of Laboratory Animals".


IN-LIFE DATES: From: Day 1 To: Day 14

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle:
Not reported.

- Amount of vehicle (if gavage):
20 ml/kg bw

- Justification for choice of vehicle:
Not reported.

- Lot/batch no. (if required):
Not reported.

- Purity:
Not reported.

MAXIMUM DOSE VOLUME APPLIED:
20 ml/kg bw

DOSAGE PREPARATION (if unusual):
The test material was suspended in corn oil and administered orally by gavage at a dosage level of 10,000 mg/kg.
Doses:
10,000 mg/kg
No. of animals per sex per dose:
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:
Daily

- Necropsy of survivors performed:
no

- Other examinations performed:
All rats were observed for mortality and pharmacotoxic signs during the first four hours after dosing, at 24 hours and daily thereafter for a total of 14 days.
Statistics:
Not reported.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 10 000 mg/kg bw
Remarks on result:
other: 95% CL not applicable
Mortality:
None of the 10 rats died during the 14-day observation period. The minimum lethal dose was found to be greater than 10,000 mg/kg.
Clinical signs:
The following pharmacotoxic signs were observed during the 14-day observation period:

Males:
Normal Hypoactivity Corneal Ptosis
Opacity
1 hour 5/5 - - -
2½ hours 2/5 3/5 - -
Days 1-5 5/5 - - -
Days 6-7 2/5 - 3/5 3/5
Day 8 2/5 - 3/5 2/5

Females:
Normal Diarrhea Hypoactivity
1, 2½ hours 5/5 - -
4 hours 4/5 1/5 1/5
Days 1-14 5/5 - -
Body weight:
The following body weights were obtained during the 14-day observation period:
Dosage Individual Sex Control 7-Day 14-Day
Level Rat Number Weight Weight Weight
(mg/kg) (grams) (grams) (grams)
10,000 62406 Male 200 260 268
62407 Male 201 259 266
62408 Male 204 274 271
62409 Male 202 259 269
62410 Male 200 253 254
62411 Female 211 253 256
62412 Female 203 240 251
62413 Female 208 242 260
62414 Female 201 226 234
62415 Female 205 225 230
Gross pathology:
Not conducted.
Other findings:
Not reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The minimum lethal dose by the oral route of administration was found to be greater than 10,000 mg/kg.
Executive summary:

Five male and 5 female rats of the Charles River CD strain weighing from 200 to 211 grams, were used for this study. The test material was suspended in corn oil and administered orally by gavage at a dosage level of 10,000 mg/kg. A volume of 20 ml/kg of body weight was administered. All rats were observed for mortality and pharmacotoxic signs during the first four hours after dosing, at 24 hours and daily there­after for a total of 14 days. None of the 10 rats died during the 14-day observation period. The minimum lethal dose was found to be greater than 10,000 mg/kg.