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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From January to April 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Directive CEE 84/449/CEE Annex V
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): DIBROMO - 1,6 - HEXANE
- Substance type: colorless liquid
- Physical state: Liquid
- Analytical purity: 98.4%
- Purity test date: 98.4%
- Lot/batch No.: TVV 01-07
- Storage condition of test material: Packaged in a glass bottle and stored in aluminium foils

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Provided by the Abbey of Bellefontaine (49122 in Bégrolles en Mauges, France)
- Age at study initiation: adult males
- Weight at study initiation: Mean: 2.5+/- 0.1 kg
- Housing: The animals were housed individually in polystyrene cages equipped with a feeder and a bottle.
- Diet (e.g. ad libitum): ad libitum - granules for rabbit reference 112 C (U .A.R., 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum - Drinking water, filtered through a membrane with 0.22 micron Millipore (Company, 78140 Velizy, France)
- Acclimation period: During 5 days - with daily observations. Systematic prophylactic treatment is undertaken in order to avoid any risk of eventual multiplication coccidial by adding to the drinking water a solution of Mucoxid (R) at a dose of 140 mg/kg/day in a volume of 10 ml/kg (Veda-Coglès, 45140 Saint Jean de la Ruelle, France)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): air-conditioned room/ the air is not recycled but filtred.
- Photoperiod (hrs dark / hrs light): 12 H light - 12 H dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml of the test substance in the conjuctival sack of the left eye. (right eye = control)

NO VEHICLE used in this study
Duration of treatment / exposure:
4 hours
Number of animals or in vitro replicates:
3 males: The single application is made on 07/02/1989 (day 1) on animal (No. 1) then 10/02/89 in 2 animals (No. 2 & 3). The animals are kept in
observation until the 4th day (72 hours).
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing

SCORING SYSTEM:
The eye reactions are evaluated 1 hour, 24, 48 and 72 hours after instillation of the product and then daily until the reversibility of the reactions using the following numerical scale (84/449/EEC Annex V and B5 Official Journal of 24 October 1984).
1) Conjunctival lesions and tearing
* chemosis (eyelids and / or nictitating membranes) - Score from 0 to 4
* lacrimation - Score from 0 to 3
* redness (applicable to conjunctival palpebral and eye, the cornea and iris) - Score from 0 to 3
* iris lesions - Score from 0 to 2
* cornea lesions
* opacity degree - Score from 0 to 4
* opacitu surface - Score from 0 to 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
redness of the conjunctiva
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
redness of the conjunctiva
Basis:
animal #2
Time point:
other: 24, 48, 72 hour mean
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Remarks:
redness of the conjunctiva
Basis:
animal #3
Time point:
other: 24, 48, 72 hour mean
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
iris score
Basis:
animal: 1, 2, and 3
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 1 h
Remarks on result:
other: no effects on iris also at 1 h
Irritation parameter:
cornea opacity score
Remarks:
Cornea opacity
Basis:
animal: 1,2, and 3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 1 h
Remarks on result:
other: no corneal changes also at 1 h
Irritant / corrosive response data:
Under the experimental conditions, the test substance DIBROMO - 1,6 - HEXANE was considered as non-irritant to rabbit eyes.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the experimental conditions, the test substance DIBROMO - 1,6 - HEXANE was considered as non-irritant to rabbit eyes. Consequently the substance is not classified for eye irritation according to Regulation No. 1272/2008 EC and amendments.
Executive summary:

Materials and Methods

Based on the skin irritation result (endpoint 7.3.1) which demonstrated that the test substance did not have a very irritant or corrosive effect, a single dose of 0.1 ml of the test substance was instilled into the conjunctival sack of the left eye of 1 then 2 male New Zealand rabbits. The eyes were not rinsed after instillation of the test substance. The ocular reactions were observed 1 hour 24, 48 and

72 hours after the instillation. The interpretation of results was carried out according to the classification criteria laid down in the EEC Directive 83/467/EEC, Commission dated 29th July 1983, according to the fifth adaptation of the technical progress council 67/548/EEC.

Results

One hour after the instillation of the test substance, moderates lesions of the conjunctiva (chemosis, redness of the conjunctivae, individual score less or equal to 2) were noted in 3 animals. After 24 hours, the conjunctival damages were slight. No iridic irritation or

corneal opacity was noted. After 48 and 72 nours, no ocular lesion persisted.