Registration Dossier
Registration Dossier
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EC number: 203-652-6 | CAS number: 109-16-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-09-12 to 1994-09-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2'-ethylenedioxydiethyl dimethacrylate
- EC Number:
- 203-652-6
- EC Name:
- 2,2'-ethylenedioxydiethyl dimethacrylate
- Cas Number:
- 109-16-0
- Molecular formula:
- C14H22O6
- IUPAC Name:
- ethane-1,2-diylbis(oxyethane-2,1-diyl) bis(2-methylacrylate)
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): BISOMER TEGDMA
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.45 to 2.70 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): rabbit diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 – 21°C
- Humidity (%): 49 – 69%
- Air changes (per hr): app. 15/h
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated contralateral 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:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize scale, OECD guideline 405
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - in 1/3 animals grade 1 redness (vessels definitily injected above normal) was observed 1 h after application; 2/3 animals showed no irritating effects at 1 h after treatment
- all eyes appeared normal at the 24, 48 and 72 h observations - Other effects:
- no other effects reported
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- TREGDMA is not irritating to the rabbit eye.
- Executive summary:
In a primary eye irritation study according to OECD guideline 405, adopted 24 February 1987, and EU method B.5, 0.1 mL of TREGDMA (purity ca. 95% according to supplier) was instilled into the conjunctival sac of 3 young adult New Zealand White rabbits (1 male, 2 females) without washing. Animals then were observed for 3 days. Irritation was scored by the method of Draize.
No effects were observed in cornea and iris. Only minimal (grade 1) redness was observed in 1/3 animals 1 h after treatment. All eyes appeared normal at the 24, 48 and 72 h observations.
In this study, TREGDMA is not irritating to the rabbit eye.
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