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EC number: 224-116-8 | CAS number: 4203-89-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Initiation date: 25-11-1986, Completion date: 28-11-1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-(1-oxa-4-azaspiro[4.5]dec-4-yl)ethyl methacrylate
- EC Number:
- 224-116-8
- EC Name:
- 2-(1-oxa-4-azaspiro[4.5]dec-4-yl)ethyl methacrylate
- Cas Number:
- 4203-89-8
- Molecular formula:
- C14H23NO3
- IUPAC Name:
- 2-{1-oxa-4-azaspiro[4.5]decan-4-yl}ethyl 2-methylprop-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Chemical name (IUPAC): Methacrylic acid, 2-(1 oxa-4- aza spiro [4, 5] dec-4-yl ethyl ester
Batch no.: 860930-DT4
Purity: )99%; major impurity p-methoxyphenol (100 ppm}
Solubility: Soluble in ethanol and toluene, decomposes in water
Appearance: Clear slightly yellow liquid
Storage: At ambient temperature in the dark in the presence of silica gel
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- not specified
- Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 43 minutes, 24 hr, 48 hr and 72 hr
- Number of animals or in vitro replicates:
- three female rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Instillation of the test substance into one of the eyes of three female rabbits slightly affected the conjunctivae. Approximately 43 minutes after exposure all three animals showed slight conjunctival redness only. In animals 3077 and 3083 the reddening had disappeared the next day and in animal 3081, 72 hours after instillation of the test substance.
Adverse effects on the cornea and the iris were not observed in any of the rabbits during the entire observation period. Treatment of the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any epithelial damage. During the first few hours after exposure lacrimation was observed in all rabbits and in animal 3083 discharge was slightly higher.
Signs of systemic intoxication were not observed. Based on the calculated Oraize score of 2 (1 hour) the test substance should be classified as minimally irritating according to the scheme of Kay and C alandra (1962). According to the EEC criteria for classification and labelling of dangerous substances, the test substance need not be labelled as an eye-irritant.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the EEC criteria for classification and labelling of dangerous substances, the test substance need not be labelled as an eye-irritant.
- Executive summary:
The purpose of the study was to evaluate the ability of the test substance to produce ocular irritation or corrosion in the rabbit following a single. application to the eye. The substance was found to be a non-irritant. According to the EEC criteria for classification and labelling of dangerous substances, the test substance need not be labelled as an eye-irritant.
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