Registration Dossier

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:
2001-03-07 to 2001-03-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1987-02-24
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Boron amorphous
- Physical state: powder
- Storage condition of test material: room temperature
- Average particle size: 0.9 µm
- Specific surface area: 11.1 m^2/g

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Highgate Farm, Market Rasen, Lincolnshire, England
- Age at study initiation: at least 10 weeks of age
- Weight at study initiation: 2.7 to 3.4 kg
- Housing: the animals were housed individually in metal cages with perforated floors.
- Diet (ad libitum): a standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet); the animals were fed hay on arrival and subsequently three times a week.
- Water (ad libitum): drinking water
- Acclimation period: a minimum period of eight days prior to the start of the study

During the acclimatisation and study period the animals were given small (approximately 5 cm x 2 cm x 2 cm) soft white untreated wood blocks for environmental enrichment.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 ± 2°C
- Relative humidity: 30 to 70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 mL of the test substance (53 to 66 mg of the test material; mean weight 61 mg) was placed in the lower everted lid of one eye of each animal.
The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated.
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
1 hour and approximately 24, 48 and 72 hours after instillation
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial inflammation or conjunctival irritation.

INITIAL AND CONFIRMATORY TESTS
One animal was treated in advance of the other two, to ensure that if a severe response was produced, no further animals would be exposed.

SCORING SYSTEM: according to the Draize scoring system


TOOL USED TO ASSESS SCORE:
Observation of the eyes was aided by the use of a handheld light.

OBSERVATIONS:
- Clinical signs: all animals were observed daily for signs of ill health or toxicity.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: Conjunctival redness (grade 1) was observed at the 1 hour observation.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: Conjunctival redness (grade 1) was observed at the 1 hour observation.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: Conjunctival redness (grade 1) was observed at the 1 hour observation.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No corneal damage or iridial inflammation was observed.
Transient hyperaemia of the blood vessels of the conjunctivae was seen in all three animals, resolving completely by one day after instillation
Other effects:
- Clinical signs: there were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A single instillation of boron amorphous into the eye of the rabbit elicited transient, very slight conjunctival irritation in all animals.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as eye irritant.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.