Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not a GLP or O.E.C.D. Testing Guideline study with few details on experimental dosing and results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Male and female rabbits were dosed with 0.1 ml of test material intothe eye. The rabbits are observed for 48 hours.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
48 hours
Observation period (in vivo):
48 hours
Number of animals or in vitro replicates:
3 male and 3 female

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
mean score
Time point:
other: 4 hour
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks:
0
Irritation parameter:
iris score
Remarks:
mean score
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks:
0
Irritation parameter:
conjunctivae score
Time point:
other: 4 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
By 48 hours, all eyes had a normal appearance

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Minor transient conjunctival irritation occured in 6 of 6 rabbits, which subsided completely after 48 hours. No injury or irititis was observed.
Executive summary:

An Acute Eye Irritation/Corrosion study was conducted with undiluted Vinyl 2 -ethylhexanoate in six rabbits. 0.1 mL was placed in one eye of each rabbit. Based on results from this test, vinyl 2 -ethylhexanoate can be classified as not irritanting. The results from this study are appropriate and reliable for predicting the eye irritation potential of Vinyl 2 -ethylhexanoate