Registration Dossier
Registration Dossier
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EC number: 223-358-1 | CAS number: 3852-09-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- An in vitro study was not conducted since an in vivo study was already available. The in vivo study was conducted in 1990.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl 3-methoxypropionate
- EC Number:
- 223-358-1
- EC Name:
- Methyl 3-methoxypropionate
- Cas Number:
- 3852-09-3
- Molecular formula:
- C5H10O3
- IUPAC Name:
- methyl 3-methoxypropanoate
- Details on test material:
- - 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: Froxfield Farms Ltd., Petersfield, Hampshire, UK
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 2960 g prior to treatment on day 1
- Housing: individually housed
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19
- Humidity (%): 30-70
- Air changes (per hr): approximately 19
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- TOOL USED TO ASSESS SCORE: handheld torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Reversibility:
- fully reversible within: 14
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- A corneal opacity had developed the day following instillation but had resolved 14 days following instillation.
Irridial inflammation was only present 3 and 4 days after instillation.
A diffuse crimson-red colouration of the conjunctivae accompanied by obvious swelling with partial eversion of the eyelids was observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Instillation of methyl-3-methoxypropionate into the eye of one rabbit elicited a positive response.
- Executive summary:
0.1 mL methyl-3 -methoxypropionate was applied to one eye of a rabbit. A corneal score >1 and a conjuntival redness score of 2 were calculated as the mean scores following grading after 1, 2 and 3 days. The effects were reversible within 14 days. These effects warrant a classification as eye irritant.
Due to the intensity of the response no further animals were exposed to the test substance.
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