Hexabromocyclododecane

Acute Toxicity: oral

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

Test material information

Constituent 1

Reference substance name:

Hexabromocyclododecane

EC Number:

247-148-4

EC Name:

Hexabromocyclododecane

Cas Number:

25637-99-4

Molecular formula:

C12H18Br6

IUPAC Name:

(1S,2S,5S,6S,9S,10S)-1,2,5,6,9,10-hexabromocyclododecane

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 or test system 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:

other: 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

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.