Registration Dossier
Registration Dossier
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EC number: 241-045-8 | CAS number: 16969-10-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June / July 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- not GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-hydroxy-3-phenoxypropyl acrylate
- EC Number:
- 241-045-8
- EC Name:
- 2-hydroxy-3-phenoxypropyl acrylate
- Cas Number:
- 16969-10-1
- Molecular formula:
- C12H14O4
- IUPAC Name:
- 2-hydroxy-3-phenoxypropyl acrylate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, FRG
- Age at study initiation: not specified
- Weight at study initiation: 2.86 - 3.14 kg
- Housing: individually
- Diet (e.g. ad libitum): about 130 g per day per animal
- Water (e.g. ad libitum): about 250 ml per day per animal
- Acclimation period: at least 8 days bafore the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): air-conditionned without details
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml
- Observation period (in vivo):
- 1h, 24h, 48h, 72h, 8d, 15d, 21d after application
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- Single application to the conjunctival sac of the right eyelid ; the substance was not washed out.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21d
- Remarks on result:
- other: individual mean results: 1-1-1
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21d
- Remarks on result:
- other: individual mean results: 0-0.67-0.33
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21d
- Remarks on result:
- other: individual mean results: 2-2-2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21d
- Remarks on result:
- other: individual mean results: 2.3-2.3-2.3
- Irritant / corrosive response data:
- The test item showed signs of eye irritation, not fully reversible in 21 days.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the experimental conditions of this study, the test item was severely irritant with irreversible effects when administered by ocular route to rabbits.
- Executive summary:
The objective of this study was to evaluate the potential irritant properties of the test item for the eye following a single administration to rabbits.
The test item was administered to 3 rabbits. Ocular reactions were observed approximately 1, 24, 48 and 72 hours, 7, 14 and 21 days after the administration.
Local clinical signs were observed in rabbits: loss of cornea tissue (2 animals), pupil contracted (all), suppuration (2 animals), discharge of blood (2 animals), marginal vascularization of the cornea (2 animals), small retractions in the eyelids (all), bloody incrustation (1 animal).
Mean scores calculated for the 3 rabbits over 24, 48 and 72 hours were: 1 for corneal opacity (individual mean score: 1-1-1), 2.3 for chemosis (2.3-2.3-2.3), 0.33 for iritis (0-0.67-0.33) and 2 for redness of the conjunctiva (2-2-2).
The effects on cornea and conjunctiva are not fully reversible into 21 days.
Under the experimental conditions of this study, the test item was severely irritant with irreversible effects when administered by ocular route to rabbits.
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