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:
2006-01-02 to 2006-01-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002-04-24
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
dated 2005-12-13

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gérome (Quaratier Labaste - F40260 Linxe)
- Weight at study initiation: 2.42 kg - 2.61 kg
- Housing: each animal was kept in an individual box (dimensions: 61 cm X 46 cm X 34 cm) installed in conventional air conditioned animal husbanding.
- Diet (ad libitum): UAR 112 from UAR in 91360 Villemoisson s/Orge, France
- Water (ad libitum): tap-water from public distribution system
- Acclimation period: a minimal 5-day acclimatisation period

ENVIRONMENTAL CONDITIONS
- Temperature: between 20°C and 22°C
- Relative humidity: between 35% and 44%
- Air recycling: at least 10 cycles per hour
- 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 item was instilled, as supplied, into the conjunctival sac of one eye, the other eye remained untreated serving as control.


Duration of treatment / exposure:
not applicable
Observation period (in vivo):
1 hour, 24, 48 and 72 hours as well as 4 days following treatment
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Both eyes of each experimental animal provisionally selected for testing should be examined before testing starts. Animals showing eye irritation, ocular defects, or pre-existing corneal injury should not be used.

SCORING SYSTEM: according to Draize scale
Any other lesions in the eye (e.g. pannus, staining) or adverse systemic effects should also be reported

TOOL USED TO ASSESS SCORE: examinations of reactions can be facilitated by use of a binocular loupe, had slit-lamp, biomicroscope or other suitable device. After recording the observations at 24 hours, the eyes may be further examined with the aid of fluorecein.

OBSERVATIONS: the systemic toxicity, expressing by behavioural abnormalities, alteration of neuro-vegetative reactions or decrease feeding, and any toxic effects are to be logged and described.
The animals are weighed at the start and at the end of the test.

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:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
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:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
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:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
It was only recorded slightly conjunctivae reactions, similar in the 3 animals and rapidly reversible: a slight redness noted 1 hour after the test item instillation and totally reversible between 4th and the 5th day of the test associated with a slight chemosis noted 1 hour after the test item instillation and totally reversible between 2nd and the 3rd day.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material is not irritating to the eye.
According to 67/548/EC and subsequent regulations, the test substance is not classified as an eye irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test substance is not classified as eye irritant.