Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
8 to 18 January 2003
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 teh 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:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-bromodecane
EC Number:
203-955-3
EC Name:
1-bromodecane
Cas Number:
112-29-8
Molecular formula:
C10H21Br
IUPAC Name:
1-bromodecane
Details on test material:
Description: colorless liquid
Assay: 99.32%w
Water: 60 mg/kg
Container: glass flask
Storage conditions: at room temperature and protected from light
Expiry date: September 2003

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
On the day of treatment, the animals were 2 to 4 months old and had a mean body weight ± standard deviation of 3.2 ± 0.1 kg.
Acclimatation: at least 5 days before the beginning of the study.
Identification: individual ear tag.
The conditions in the animal room were set as follows:
- temperature: 18±3°C
- relative humidity: 30 to 70%
- light/dark cycle: 12h/12h
- ventilation: approximately 12 cycles/hour of filtered, non-recycled air
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these daily checks, the housing conditions and corresponding instrumentation and equipment were verified and calibrated at regular intervals.

The animals were housed individually in polystyrene cages (48.2 x 58 x 36.5 cm).
Each cage was equiped with a food container and a water bottle.

All the animals had free access to 110 pelleted diet.
Food is analysed regularly by the supplier for composition and contaminant levels.

Drinking water filtered by a FG Millipore membrane (0.22 µm) was provided ad libitum.
Bacteriological and chemical analyses of water are performed regularly by external laboratories. These analyses include the detection of possible contaminants (pesticides, heavy metals and nitroamines).

No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye served as control
Amount / concentration applied:
Single dose of 0.1 mL of the undiluted test item
Duration of treatment / exposure:
The lower and upper eyelids were held together for about one second to avoid any loss of test item.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
The day before treatment, the eyes of each animal were examinated in order to check the absence of any signs of ocular irritation, ocular defects or pre-existing corneal injury.

The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test item.
Since there was persistent ocumar reactions at 72 hours, the observation period was extended up to their complete reversibility (day 7).

Conjunctival reactions, iritis and corneal opacification were evaluated daily for each animal.
For the evaluation of corneal opacification (presence or absence, affected area), the eyes were examined under a UV lamp after instillation of one or two drops of 0.5 % sodium fluorescein solution (a clear fluorescenceis visible in the areas of opacification). This evaluation was performed on day 2 and repeated thereafter whenever necessary.

As possible effects were anticipated, the test item was administered to a single animal in the first instance. Since the test item was not severily iriitant on this animal, it was then evaluated on two other animals.
A single dose of 0.1 ml of the undiluted test item was instilled into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball.
The lower and upper eyelids were held together for about one second to avoid any loss of test item.
The eyes were not rinsed after administration of the test item.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
13
Max. score:
21
Reversibility:
fully reversible within: 6 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
1
Max. score:
21
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
6
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
12
Irritant / corrosive response data:
Very slight to moderate conjunctival reactions including very slight to moderate chemosis (grades 1 to 3), very slight or slight redness of conjunctiva (grade 1 or 2) and clear discharge were observed in all animals on day 1: some of these ocular reactions persisted up to day 6 at the latest.
Other effects:
No other ocular reactions were noted during the study.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information The etst material was declared as non irritating in the original report Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the test material was classified as non irritating. Conjonctivae irritation observed at 1 hour fully reversed within 6 days. No other irritation was observed.
Executive summary:

The ocular irritation of the test material was determined according to the following guidelines: OECD 405 and EU Method B.5. Three New Zeland White Rabbits were exposed to 0.1 mL of the test material and observed over a 72 hours period. Under the condition of the test, moderate conjunctivae irritation was observed at 1 hour being scored 13 out of 21. This was fully reversible within 6 days. No other ocular effects were noted over the 72 hour observation period.

According to Regulation 1272/2008, the test material is classified as an eye irritant with hazard statement H319.