Registration Dossier
Registration Dossier
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EC number: 229-114-0 | CAS number: 6413-10-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not reported
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The substance used in the study is not representative of the substance to be registered; rather it is a diluted mixture containing the registered substance at 50 % in olive oil. The duration of treatment, and the period of observation, was not reported. There are a number of reporting deficiencies, however, overall it can be seen that the study was performed to sound scientific principles.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- study pre-dates GLP
Test material
- Reference substance name:
- Ethyl 2-methyl-1,3-dioxolane-2-acetate
- EC Number:
- 229-114-0
- EC Name:
- Ethyl 2-methyl-1,3-dioxolane-2-acetate
- Cas Number:
- 6413-10-1
- Molecular formula:
- C8H14O4
- IUPAC Name:
- ethyl 2-(2-methyl-1,3-dioxolan-2-yl)acetate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS (white rabbits)
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: Individually housed
- Diet: standard diet, ad libitum
- Water: ad libitum from automatic drinkers
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 20 °C
- Humidity (%): aproximately 50 %
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Test system
- Vehicle:
- other: olive oil
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
The test material was tested at 50% in olive oil. - Duration of treatment / exposure:
- - Dose administration: 0.1 mL of the test material formulation was applied into the conjunctival sac of one eye of each rabbit. The lids were then gently held together for one minute after which the animal was released. The other eye was treated with water (control eye).
- Observation period (in vivo):
- Not reported.
- Number of animals or in vitro replicates:
- 4 males and 4 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 1 minute the treated eyes of half of the animals were washed with 10 - 20 mL lukewarm saline.
SCORING SYSTEM
The reactions, following treatment, were observed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- The test material formulation was concluded not to be irritating to the mucous membranes of eyes.
Any other information on results incl. tables
The test material formulation was concluded not to be irritating to the mucous membranes of eyes under the conditions of the test..
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material formulation was concluded not to be irritating to the mucous membranes of eyes.
- Executive summary:
The eye irritation potential of the test material formulation was assessed in a study which was conducted according to a methodology which was similar to that which is outlined in the standardised guideline OECD 405. 0.1 mL of test material formulation was instilled into one eye of each of eight rabbits, the other eye was treated with water and acted as the control eye. One minute after instillation, the treated eyes of half of the animals was rinsed with 10 - 20 mL lukewarm saline. Any adverse effects were noted. Under the conditions of the study the test material formulation was concluded not to be irritating to the mucous membranes of eyes.
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