Registration Dossier
Registration Dossier
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EC number: 479-950-7 | CAS number: 31274-51-8
Eye irritation
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:
- 2 003
- 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
- Test material form:
- solid: bulk
- Details on test material:
- Please refer to "Confidential details on test material".
Constituent 1
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
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