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Registration Dossier
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EC number: 218-542-3 | CAS number: 2177-70-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-08-20 to 2012-09-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study. GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Phenyl methacrylate
- EC Number:
- 218-542-3
- EC Name:
- Phenyl methacrylate
- Cas Number:
- 2177-70-0
- Molecular formula:
- C10H10O2
- IUPAC Name:
- phenyl 2-methylprop-2-enoate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Phenyl methacrylate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand White (Hsdlf:NZW)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.38 to 2.89 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): min. 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- eyes were not rinsed after application
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope
Initially, a single rabbit was treated. After consideration of the ocular responses produced in the first treated animal, a second animal was treated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in both animals one hour after treatment (grade 2 conjunctival redness, grade 1 chemosis), minimal conjunctival irritation (grade 1 redness) at the 24 h observation. No irritating effects were observed after 48 h. - Other effects:
- Both animals showed the expected body weight gains during the study.
Any other information on results incl. tables
Eye reaction |
Animal 1 |
Animal 2 |
Score after 1/24/48/72 h |
Score after 1/24/48/72 h |
|
Cornea, opacity (max. score 4) |
0/0/0/0 |
0/0/0/0 |
Iris (max. score 2) |
0/0/0/0 |
0/0/0/0 |
Conjunctivae, redness (max. score 3) |
2/1/0/0 |
2/1/0/0 |
Conjunctivae, chemosis (max score 4) |
1/0/0/0 |
1/0/0/0 |
Conjunctivae, discharge (max. score 3) |
2/1/0/0 |
1/0/0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- PHMA is not irritating to the rabbit eye.
- Executive summary:
In a primary eye irritation study according to OECD guideline 405 (adopted 24th April 2002), 0.1 mL of PHMA (99.6% a.i.) was instilled into the conjunctival sac of 2 male 12 to 20 weeks old New Zealand White rabbits without washing. Animals then were observed for 3 days. Irritation was scored by the method of Draize.
No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in both animals one hour after treatment (grade 1 conjunctival redness, grade 1 chemosis), minimal conjunctival irritation (grade 1 redness) at the 24 h observation. No irritating effects were observed after 48 h.
In this study, PHMA is not irritating to the rabbit eye.
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