Hexabromocyclododecane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

Two male and 2 female New Zealand White rabbits (obtained from Kuiper's Rabbit Ranch, Gary, Indiana) were used for this study. The rabbits weighed from 2308 to 2370 grams at the beginning of this study. They were individually housed in metal metabolism 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 Rabbit Chow were available ad libitum. Body weights were measured initially and at 7 and 14 days.

The hair was removed from the back of each rabbit (20-30% of the body surface) with an electric clipper. The skin of one male and one female was abraded by making shallow incisions with a scalpel blade, not sufficiently deep to cause bleeding. The test material was applied once only to the backs of the rabbits at a dosage level of 20,000 mg/kg using 0.9% Physiological Saline as the wetting agent.

The area of application was wrapped with gauze bandaging and occluded with Saran Wrap. Twenty-four hours later the bandages were removed and the backs were washed with tepid tap water. They were observed at 24 hours and daily thereafter for a total of 14 days for mortality and pharmacotoxic signs.

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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
Kuiper's Rabbit Ranch, Gary, Indiana.

- Age at study initiation:
Not reported.

- Weight at study initiation:
2308-2370 grams

- Fasting period before study:
Not applicable.

- Housing:
Animals were individually housed in metal metabolism cages in temperature and humidity controlled quarters.

- Diet (e.g. ad libitum):
Ad libitum

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

- Acclimation period:
Not reported.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
Not reported.

- Humidity (%):
Not reported.

- Air changes (per hr):
Not reported.

- Photoperiod (hrs dark / hrs light):
Not reported.

IN-LIFE DATES: From: day 1 To: day 15

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: 0.9% Physiological Saline

Details on dermal exposure:

TEST SITE
- Area of exposure:
20-30% of the body surface.

- % coverage:
Not reported.

- Type of wrap if used:
The area of application was wrapped with gauze bandaging and occluded with Saran Wrap.

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Yes

- Time after start of exposure:
Twenty-four hours after the commencement of the exposure the bandages were removed and the backs were washed with tepid tap water.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
20,000 mg/kg

- Concentration (if solution):
Not applicable.

- Constant volume or concentration used:
yes

- For solids, paste formed:
yes, the test material was applied once only to the backs of the rabbits at a dosage level of 20,000 mg/kg using 0.9% Physiological Saline as the wetting agent.

VEHICLE
Not applicable.

Duration of exposure:

24 hours.

Doses:

20,000mg/kg

No. of animals per sex per dose:

2 males and 2 females

Control animals:

no

Details on study design:

- Duration of observation period following administration:
14 days

- Frequency of observations and weighing:
The animals were observed at daily during the 14 days following the exposure for mortality and pharmacotoxic signs. Body weights were measured at 7 and 14 days

- Necropsy of survivors performed:
no

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
None reported.

Statistics:

Not reported.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 20 000 mg/kg bw

Remarks on result:

other: 95% CL not reported.

Mortality:

None of the rabbits died during the 14-day observation period. The minimum lethal dose by the dermal route of administration was found to be greater than 20,000 mg/kg.

Clinical signs:

other: No treatment related signs were noted in the test animals.

Gross pathology:

Not applicable.

Any other information on results incl. tables

Table 1: Bodyweights.

Dosage Level mg/kg	Individual Rabbit No.	Sex	Control Weight (grams)	7-Day Weight (grams)	14-Day Weight (grams)
20000	28969	Male	2370	2302	2375
	28979	Male	2310	2362	1800
	28950	Female	2308	2331	2297
	28984	Female	2325	2233	2144

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 dermal route of administration was found to be greater than 20,000mg/kg.

Executive summary:

Two male and 2 female New Zealand White rabbits were used for this study.

The hair was removed from the back of each rabbit (20-30% of the body surface) with an electric clipper. The skin of one male and one female was abraded by making shallow incisions with a scalpel blade, not sufficiently deep to cause bleeding. The test material was applied once only to the backs of the rab­bits at a dosage level of 20,000 mg/kg using 0.9% Physiological Saline as the wetting agent.

None of the rabbits died during the 14-day observation period. The minimum lethal dose by the dermal route of administration was found to be greater than 20,000 mg/kg.