Registration Dossier
Registration Dossier
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EC number: 444-370-5 | CAS number: 669005-94-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-01-21 to 2001-02-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline and GLP-compliant study
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:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- RCC Ltd.
Test material
- Reference substance name:
- -
- EC Number:
- 444-370-5
- EC Name:
- -
- Cas Number:
- 669005-94-1
- Molecular formula:
- C28 H23 F3 N6
- IUPAC Name:
- 4-methyl-2,6-bis[(4-methylphenyl)amino]-5-{2-[2-(trifluoromethyl)phenyl]diazen-1-yl}pyridine-3-carbonitrile
- Details on test material:
- - Description: Orange solid
- Stability of test item: Stable under storage conditions
- Expiry date: 01-OCT-2005
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes; F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 13 weeks (male); 10-11 weeks (females)
- Housing: Individually, in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water: Community tap water from Fullinsdorf, ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: 10-15 air changes per hour
- Photoperiod: 12 hours light and 12 hours dark
In-Life-phase: 21-JAN-2003 to 03-FEB-2003
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- 1, 24, 48 and 72 hours, as well as 7 days after test item application
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The treated eyes were not rinsed after instillation.
SCORING SYSTEM: The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours, as well as 7 days after application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable, no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24,48,72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24,48,72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24,48,72 hours
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24,48, 72 hours
- Score:
- 0.89
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24,48,72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable, no effects
- Irritant / corrosive response data:
- No corrosion of the cornea was observed at any of the reading times.
- Other effects:
- - No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- Light orange staining of the treated eyes produced by the test item was observed in all animals at the 1 -hour examination and persisted in two animals up to 24 hours and in one animal up to 48 hours after treatment. Orange remnants of the test item were observed in the eye or conjunctival sac of all animals one hour after treatment.
- The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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