1-bromohexane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 30-04-1993 to 03-11-1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no deviations from standard test guidelines and no methodological deficiences, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guidelines 404 -

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

n-Hexyl bromide

IUPAC Name:

n-Hexyl bromide

Test material form:

other: Liquid

Details on test material:

Colourless liquid
Glass flask containing 53 g
Date of receipt: 07-05-1993
Purity > 98.5 %
Storage conditions : at room temperature, away from light

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Details on test animals or test system and environmental conditions:

Breeder: Elevage Cunicole de Val de Selle, 80160 PROUZEL, FRANCE
3 animals were used. The animals were identified individually with a metal tag in the ear.
Weight: on the day of treatment, the animals had a mean body weight of 2.3 ± 0.2 kg.
Acclimatization: at least 5 days before the beginning of the study.
Selection of the animals: the day before treatment, the eyes of each animal were examined in order to use only animals without any signs of cutaneous irritation.
During the acclimatization period and during the main test, the conditions in the animal room were as follow:
temperature: 18 ± 3°C
relative humidity: 50 ± 20 %
light/darkness cycle: 12 h/ 12 h
ventilation: about 13 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were recorded continuously and records retained.
The housing conditions (temperature, relative humidity, light/dark cycle and ventilation) were checked monthly.
The animals were housed in polystyrene cages (35x 55 x 32 cm). Each cage wa equipped with a food container and a water bottle.
All the animals had free access to 112 C pelleted diet.
Each batch of food was analysed (composition and contaminants) by the supplier.
Drinking water filtered by a F.G. Millipore membrane (0.22 micron) was contained in bottles and provided ad libitum.
Bacteriological and chemical analysis of the water and detection of possible contaminants (pesticides, heavy metals and nitrosamines) ae performed periodically.
There were no contaminants in the diet or water at level likely to have influenced the outcome of the study.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The day before tretment, the flanks of each animal were clipped using electric clippers. Only animal showing no obvious signs of irritancy were used for the study.
As the test substance was anticipated to be irritant, a preliminary assay was conducted on 1 animal with an application of the test substance for 4 hours. The result were then confirmed using 2 additional animals.
A dose of 0.5 ml of the test substance in its original form was applied to a 6 cm2 dry hydrophilic gauze patch and this was then applied to the right flank of the animals.
The left flank did not receive any test substance and served as control. The etst substance and the gauze patch were held in contact with the skin for 4 hours by means of an adhesive hypoallergic aerated semi-oclusive dressing and a restraining bandage.
Subsequently, the dressings were removed and no residual test substance was observed.
The animals were then replaced into their individual cages.

Duration of exposure:

4 days

Doses:

0.5 ml of test substance

No. of animals per sex per dose:

3 animals

Control animals:

other: The left flank of the animals was used as control

Details on study design:

The skin was examined approximately 1, 24, 48 and 78 hours after removal of the dressing.
As there was persistent cutaneous irritation after 72 hours, the observation period was extended to a maximum of 14 days (until day 15) in order to determine the progress of the lesions and theur irreversibility.
Any change in the animals' behaviour was noted.

Results and discussion

Preliminary study:

Marked cutaneous reactions were observed for up to 72 hours after removal of the dressing. They consisted of erythema and oedema, scores of 2 to 4 in 3 and 2 animals, respectively.
Erythema was no longer noted on day 8 and oedema by day 6.

Effect levels

Sex:

not specified

Dose descriptor:

LD0

Effect level:

0.5 other: ml per animal

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

other: A dryness of the skin was observed at the treatment site of all the animals between days 6 and 15. No ulceration or necrosis was noted.

Gross pathology:

No autopsy done

Other findings:

N/A

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category II

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

As the means scores for erythema, oedema for 2 out of the 3 animals reached the crietria values for irritation, under our the experimental conditions, the test substance, n-Hexyl bromide, was considered as irritant when administred by cutaneous route in rabbits.
It as to be classifed as Skin Irrit. 2 with H315 Causes skin irritation

Executive summary:

Marked cutaneous reactions were observed for up to 72 hours after removal of the dressing. They consusted of erythema and oedema, scores of 2 to 4 in 3 and 2 animals, respectively. The mean score over 24, 48 and 72 hours for individual animals was 2.0, 2.7 and 2.7 for erythema and 0.0, 2.0 and 2.7 for oedema.

Erythema and oedema had reversed by day 8.

Between days 6 and 15, a dryness of the skin was observed at the treatment site. On day 15, a dryness of the skin persisted.

No ulceration or necrosis was noted.