Registration Dossier
Registration Dossier
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EC number: 288-509-6 | CAS number: 85736-97-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 Feb. 87
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich
- EC Number:
- 288-509-6
- EC Name:
- 2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich
- Cas Number:
- 85736-97-6
- Molecular formula:
- Unspecified
- IUPAC Name:
- 11-methyldodecyl 2-methylprop-2-enoate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, D- 4932 Extertal
- Age at study initiation: 10 weeks
- Housing: individually
- Diet (e.g. ad libitum): conventional laboratory diet (mümmel z, ssniff/Soest), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±2°C
- Humidity (%): 40 - 50%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 8 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the 24 h observation, the corneas were examined with fluorescein
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: ophthalmoscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Discharge
|
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max. score: 3 |
|
1 h |
0/0/0 |
0/0/0 |
0/0/1 |
0/0/0 |
1/0/1 |
24 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
8 d |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, Isotridecyl Methacrylate is not irritating to the eyes.
- Executive summary:
In a primary eye irritation study according to OECD Guideline 405 (1987) 0.1 mL of Isotridecyl Methacrylate (91.4%) was instilled into the conjunctival sac of the right eye of young adult New Zealand White rabbits. The eyes were rinsed after 24 h. Animals then were observed for 8 days. Irritation was scored by the method of Draize.
Grade 1 conjunctival redness was observed in 1/3 animals after 1 h, grade 1 discharge was observed in 2/3 animals after 1 h. No other reactions were noted.
In this study, Isotridecyl Methacrylate is not irritating to the eyes.
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