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Registration Dossier
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EC number: 213-107-4 | CAS number: 924-50-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: EG Guideline B.5. Akute Toxizität Augenreizung der Richtlinie 84/449/EWG
- Qualifier:
- according to guideline
- Guideline:
- other: Richtlinie 83/467/EWG
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-Methylcrotonsäuremethylester
- IUPAC Name:
- 3-Methylcrotonsäuremethylester
- Reference substance name:
- Methyl 3-methyl-2-butenoate
- EC Number:
- 213-107-4
- EC Name:
- Methyl 3-methyl-2-butenoate
- Cas Number:
- 924-50-5
- Molecular formula:
- C6H10O2
- IUPAC Name:
- methyl 3-methylbut-2-enoate
- Test material form:
- other: liquid
- Details on test material:
- Purity: 97.3 %, colourless liquid, storage at: 22 °C (dark under the hood)
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- BW: 2.8-3.7 kg, Age of the animals: 3-5 months, Room temperature: 20+/- 3 °C, humidity: 50%+/- 20% , Light/dark: 12h/12h, feeding: Altromin 2123 Haltungsdiet- Kaninchen, Altromin GmbH, Lage/Lippe, ad libitum plus hay (15 g per day) Source: Hoechst AG, Kastengrund
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye was the negative control
- Amount / concentration applied:
- 0.1 mL Dimethylacrylic acid methyl ester per eye
- Duration of treatment / exposure:
- one administration of the substance
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 animals (single housing)
- Details on study design:
- 24 h before the experiment started the rabbits were examined conerning damaged cornea. One drop of sodium fluorescein ( 0.01 %) was administrated and examined under UV- light conditions. The left eye was treated with 0.1 mL Dimethylacrylic acid methyl ester. 24h after the treatment the eyes were rinsed with sodium chlorid (physiological; 37 °C ). 24h and 72 h after the administration the eyes again were examined regarding cornea damages. The observation of the eyes was 1h/24h/48h and 72 h after the exposure. Details about the result of iris, cornea and conjuctiva is available in the attachment (Attached Background material).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h,48h,72h
- Score:
- 0.9
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Other effects:
- 1 h after exposure: discharge of clear, colourless liquid
24 h after exposure: swollen lids.
48 h after exposure: hyperaemia ( conjuctiva)
72 h after exposure: All symptomes were totally reversible
Any other information on results incl. tables
See attachment (attached background material)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not irritating to the eye.
- Executive summary:
1 h after exposure: discharge of clear, colourless liquid
24 h after exposure: swollen lids.
48 h after exposure: hyperaemia (conjuctiva)
72 h after exposure: All symptomes were totally reversible
The result of this experiment: Dimethylacrylic acid methyl ester is not irritating.
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