Registration Dossier
Registration Dossier
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EC number: 410-560-1 | CAS number: 153519-44-9 CGL 400
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline conform, animal housing: air cycles per hour not mentioned, started with one animal, two extra animals were added one week later
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The present study was started with one single animal. Because only slight reactions were observed, two extra rabbits were added to the test later.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxyphenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane
- EC Number:
- 410-560-1
- EC Name:
- Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxyphenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane
- Cas Number:
- 153519-44-9
- Molecular formula:
- C28 H28 N3 O4 + C12 H25 / C13 H27 (represents two main components)
- IUPAC Name:
- Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxy phenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- Age at study initiation: 9-13
- Weight at study initiation: 2630 to 2800 g
- Housing: The animals were housed individually in metal cages, identified by ear tattoo
- Diet (e.g. ad libitum): ad libitum, Nafag No. 814, Gossau, Switzerland
- Water (e.g. ad libitum): fresh water ad libitum
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 30-70
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES:
Start of experiment: January 22, 1991
End of experiment: February 5, 1991
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of the test substance
- Observation period (in vivo):
- 7d
- Number of animals or in vitro replicates:
- one, two extra animals were added one week later
- Details on study design:
- SCORING SYSTEM: OECD scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24-72h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24-72h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24-72h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritant / corrosive response data:
- Under the experimental conditions the test article induced irritation (redness and chemosis) of the conjunctiva when instilled into the conjunctival sac of albino rabbits' eyes. All reactions were reversible within 7d.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Because the mean values of the readings 24 to 72 hours after instillation are below the threshold of significance, the test article can be classified as non-irritant according to the Commission Directive 83/467/EEC
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