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Toxicological information

Eye irritation

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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:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
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]dec-4-yl)ethyl methacrylate
Test material form:
liquid
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
Remarks:
redness
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:
conjunctivae score
Remarks:
swelling (chemosis)
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.