Registration Dossier
Registration Dossier
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EC number: 701-028-2 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-(2-methyloctyl)phenyl bis(4-nonylphenyl) phosphite
- EC Number:
- 701-028-2
- Cas Number:
- 26523-78-4
- Molecular formula:
- C45H69O3P
- IUPAC Name:
- 4-(2-methyloctyl)phenyl bis(4-nonylphenyl) phosphite
- Reference substance name:
- Nonylphenol
- EC Number:
- 246-672-0
- EC Name:
- Nonylphenol
- Cas Number:
- 25154-52-3
- IUPAC Name:
- 2-nonylphenol
- Test material form:
- liquid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as the control.
- Amount / concentration applied:
- undiluted: Amount applied: 0.1 ml
- Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- Eyes were examined at 1, 24, 48 and 72 hours after treatement. After recording the observations at 24 hours, the eyes of all rabbits were examined with the aid of fluorescein to further characterise corneal opacity.
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- Comment: not rinsed
Results and discussion
In vivo
Results
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- Draize scoring system
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hr
- Irritant / corrosive response data:
- Corneal opacity : No corneal opacity was observed in any of the treated eyes at any of the observation periods. Iris : the iris response was normal in all treated eyes.Conjunctivae : slight conjunctival redness and chemosis were observed in all three treated eyes at the 1-hour observation point (grading score of 1). Conjunctival redness and chemosis persisted in 2 of 3 animals for 24 hours and was resolved by the 48 hour time point. In the third animal, all signs of irritation were resolved by the 24-hour observation point.
- Other effects:
- All of the animals exhibited an increase of body weight during the course of the study.
Any other information on results incl. tables
No overt sign of toxicity other than the ocular effects was evident during the course of the study in any of the animals.
No fluorescein staining was observed in any of the treated eyes at all observation points.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: other: Used for data submission
- Conclusions:
- Classification: not irritating
- Executive summary:
Used for data submission
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