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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 30-04-1993 to 07-01-1994
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:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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 3.1 ± 0.3 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 ocular 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.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye, which remained untreated, served as a control.
Amount / concentration applied:
As the cutaneous study performed at C.I.T. revealed irritant effects, the test substnace was administrated initially to one animal. As the test performed on one eye revealed no very irritant effect, the study was continued using 2 other animals.
A single dose of 0.1 ml of the test substance in its original form was instilled into the conjunctival sac of the left eye of 3 animals after gently pulling the lower lid away from the eyeball.
The right eye, which remained untreated, served as a control.
Duration of treatment / exposure:
The lower and upper eyelids were held together for about one second to avoid any loss of test substance.
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
3
Details on study design:
The eyes were not rinsed after administration of the test substance.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hr
Score:
<= 0.3
Max. score:
0.3
Reversibility:
fully reversible
Irritant / corrosive response data:
See attached table
Other effects:
A slight redness of the conjunctiva (animal nb 3) on day 1 (1 hour) and a slight discharge (animals nb 2 and 3) on day 3 were noted.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions, the test sustance, n-Hexyl bromide, was considered as non-irritant when administred by ocular route in rabbits.
Executive summary:

In one animal, no ocumar reactions were observed during the study. In 2 animals, a discharge was noted after 48 hours post-instillation. In one animal, a redness was noted after 1 hour.

No chemosis, no iris lesion and no corneal opacity were noted 24, 48 and 72 hours post-instillation.