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EC number: 221-950-4 | CAS number: 3290-92-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
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- Short-term toxicity to fish
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 11 to 21, 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no data on non-ocular local and systemic adverse effects
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Propylidynetrimethyl trimethacrylate
- EC Number:
- 221-950-4
- EC Name:
- Propylidynetrimethyl trimethacrylate
- Cas Number:
- 3290-92-4
- Molecular formula:
- C18H26O6
- IUPAC Name:
- 2,2-bis[(methacryloyloxy)methyl]butyl methacrylate (non-preferred name)
- Test material form:
- other: Clear colourless liquid
- Details on test material:
- - Name of test material (as cited in study report): TMPTMA
- Physical state: Clear colourless 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: David Percival Ltd, Moston, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: Individually housed in suspended cages
- Diet (e.g. ad libitum): Certified Rabbit Diet (Code 5322) (BCM IPS Limited, London, UK), ad libitum
- Water (e.g. ad libitum): Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hour): 15/hour
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume with unit): 0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: Not applicable
SCORING SYSTEM: Draize (1977) scoring system
TOOL USED TO ASSESS SCORE: Eye examinations were performed using light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- for each animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- for each animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- for each animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- - Minimal conjunctival irritation was noted in all treated eyes 1 and 24 hours after treatment and in one treated eye at the 48 hour observation; irritation completely resolved within 72 hours
- See table 1 and 2 for further details - Other effects:
- No data
Any other information on results incl. tables
Table 1: Individual eye irritation scores
Animal |
Time after dosing (hours) |
Cornea |
Iris |
Conjunctivae |
|||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
|||
126 Male |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
24 |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 |
0 |
0 |
0 |
1 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
30 Male |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
24 |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
31 Male |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
24 |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 2: Mean (24, 48 and 72 hours) value eye irritation scores
Animal |
Corneal opacity |
Iris |
Conjunctivae |
|
Redness |
Chemosis |
|||
126 Male |
0 |
0 |
0.7 |
0 |
30 Male |
0 |
0 |
0.3 |
0 |
31 Male |
0 |
0 |
0.3 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not eye irritating
- Conclusions:
- Under the test conditions, TMPTMA is not classified as irritating to the eye according to the CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted TMPTMA in their right eye (under local anaesthesia) while the other eye corresponded to the control. The eyes were examined unwashed and the changes were observed at 1, 24, 48 and 72 hours after dosing and graded according to the method of Draize (1977).
Minimal conjunctival irritation was noted in all treated eyes 1 and 24 hours after treatment and in one treated eye at the 48 hour observation. The irritation completely resolved within 72 hours. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0.7, 0.3, 0.3 for conjunctivae score and 0, 0, 0 for chemosis score.
Under the test conditions, TMPTMA is not classified as irritating to the eye according to the CLP Regulation (EC) N° 1272-2008.
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