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:
2003-09-03 - 2003-12-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 405) performed under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted on 24th Feb 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
adopted on 31st July 1992
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid: bulk
Details on test material:
Please refer to "Confidential details on test material".

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 - 4 months old
- Body weight at study initiation: 3.2 ± 0.4 kg
- Housing: animals were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
- Diet: 110 pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France), ad libitum
- Water: Drinking water filtered by a FG Millipore membrane (0.22 micron), ad libitum
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- Humidity: 30 - 70%
- Air changes: approximately 12 air changes/hour (filtered, non-recycled air)
- Photoperiod: 12 h / 12 h

IN-LIFE DATES: From: 2003-09-17 To: 2003-09-26

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye, which remained untreated, served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg/rabbit
Duration of treatment / exposure:
Single treatment. The treated eyes were not rinsed after instillation.
Observation period (in vivo):
72 hours (assessment of eye reactions at 1, 24, 48 and 72 hour(s)).
The study was ended on day 4 in the absence of persistent ocular reactions.
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
TEST ITEM PREPARATION / TEST SITE
- 100 mg of the test item was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test item.

REMOVAL OF TEST SUBSTANCE
- Washing: The eyes were not rinsed after instillation.

SCORING SYSTEM: numerical scoring system according to the OECD guideline 405

TOOL USED TO ASSESS SCORE: UV lamp, fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(all animals)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
(all animals)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU