1,6-dibromohexane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,6-dibromohexane

EC Number:

211-067-2

EC Name:

1,6-dibromohexane

Cas Number:

629-03-8

Molecular formula:

C6H12Br2

IUPAC Name:

1,6-dibromohexane

Details on test material:

- Name of test material (as cited in study report): 1,6-Dibromohexane
- Substance type: Colorless liquid
- Physical state: liquid
- Analytical purity: 98.97%
- Purity test date: 98.97% - 13 February 2002
- Lot/batch No.: 003/98
- Expiration date of the lot/batch: December 2002
- Storage condition of test material: at room temperature, protected from light and humidity

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: rat, Sprague-Dawley Rj: SO (lOPS Han) - Provided by Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: 9 weeks old
- Weight at study initiation:
* Males: 277 ± 9 g
* Females: 237 ± 7 g
- Housing: During the acclimation period, one to seven animals of the same sex were housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). During the treatment period, the animals were housed individually in the same cages. Each cage contained autoclaved sawdust (SICSA, Alfortville, France). Sawdust is analysed by the supplier for composition and contaminant levels.
- Diet : Free access to A04 C pelleted diet (UAR, Villcmoisson, Epinay-sur-Orge, France)
- Water: Ad libitum - filtered by a FG Millipore membrane (0.22 micron). Bacteriological and chemical analyses of water are performed regularly by external laboratories.
- Acclimation period: At least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): Approximately 12 cycles/hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area (area 6 cm x 8 cm)
- % coverage: 10% of the total body surface of the animal calculated according to Meeh's formula (i.e. approximately 5 cm x 6 cm for the females and 5 cm x 7 cm for the males).
- Type of wrap if used: A hydrophilic gauze pad

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.25 ml/kg
- Concentration (if solution): undiluted

VEHICLE : No vehicle used

Duration of exposure:

24 hours

Doses:

Limit test at 2000 mg/kg

No. of animals per sex per dose:

Ten animals (5 males and 5 females)

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
* Clinical signs and mortality: frequently during the hours following administration of the test item, thereafter, observation of the animals was made at least once a day until day 15.
* Body weight: weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
- Other examinations performed: Pathology: macroscopic examination as soon as possible after death. A macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnonnalities).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs were noted during the study. Dryness of the skin was noted in 1/5 females from day 6 up to day 12. No other cutaneous reactions were observed.

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: Council Directive 67/548/EEC and adaptations

Conclusions:

Under our experimental conditions, the dermal LD0 of the test item 1,6-Dibromohexane is higher than 2000 mg/kg in rats. No mortality was observed in anhy of the animals at 2000 mg/kg bw.

Executive summary:

The acute dermal tox:icity of the test item 1,6-Dibromohex:ane (batch No. 003/98) was evaluated in rats according to OECD (No. 402, 24th February 1987) and EC (92/69/EEC, B3, 31st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

Methods

The test item was applied to the skin of one group of ten Sprague-Dawley rals (five males and five females).

The application was performed with the undiluted test item at the dose of 2000 mg/kg, taking into consideration that its specific gravity was 1.6 g/mL. The test site was then covered by a semi-occlusive dressing for 24 hours.

Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test item.

All animals were subjected to necropsy.

Results

No clinical signs and no deaths were observed during the study.

A reduced weight gain or a slight body weight loss was seen in 4/5 females between day 1 and day 8. The overall body weight gain of the other animals was similar to that of CIT historical control animals.

Dryness of the skin was noted in 1/5 females from day 6 up to day 12. No other cutaneous reactions were observed.

No apparent abnormalities were observed at necropsy in any animal.

Conclusion

Under the applied ex:perimental conditions, the dermal LD0 of the test item 1,6-Dibromohexane (batch No. 003/98) is equal to or higher than 2000 mg/kg in rats. No classification for acute dermal toxicity according to Regulation EC 1272/2008 and amendments is warranted.