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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not a GLP or O.E.C.D. Testing Gudeline study. A volume of 0.2 ml of the test substance was instilled into the test eyes, current testing guidelines recommend a volume of 0.1 ml.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Register (28, 110, 6.6.1963, para. 191.12, "Test for Eye Irritants")
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As per Vinyl Neodeconate IUCLID Data Set 2007.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.2 ml undiluted
Duration of treatment / exposure:
No data
Observation period (in vivo):
Seven days
Number of animals or in vitro replicates:
Four
Details on study design:
Four New Zealand white rabbits were dosed with 0.2 ml of undiluted vinyl neodecanoate to determine the potential for eye irritation using the Draize method. The test substance was instilled into the conjunctival sac of one eye of each of four rabbits while the untreated eyes were used as controls.
The method of Draize as described in the Federal Register (28, 110, 6.6.1963, para. 191.12, "Test for Eye Irritants") was used. Irritation to the cornea, iris, conjunctiva, chemosis and discharge were assessed visually at 1, 2, 3, and 7 days, then every 4 days until complete recovery. The authors used raw numbers in the reporting. The amount of material used for the dosing (0.2 ml) was twice the amount that is recommended for this type of testingincluding currrent testing guidelines. Also, a non-whole number was used to score the only lesion observed in the conjunctiva (0.5). Immediately after instilling vinyl neodecanoate into the rabbit eye's there was a slight pain reaction. According to the Draize method any sign of redness in the conjunctiva should be scored with a minimum of 1 (transformed score of 1 = 2), even if the observed effect was slight.

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Remarks:
One animal had redness of 0.5 at 1-2 hr.
Time point:
other: 1-2 hours after instillation.
Score:
>= 0.5
Max. score:
1
Reversibility:
fully reversible within: one day
Irritant / corrosive response data:
Immediately after instilling vinyl neodecanoate into the rabbit eye's there was a slight pain reaction. During the 7 days of observation the only effect reported was redness in the conjunctiva, within 1-2 hr after exposure. The raw score was 0.5 (1). According to the Draize method any sign of rednessin the conjunctiva should be scored with a minimum of 1 , even if the observed effect was slight. No other effects were noted for the iris or the cornea. This effect was transient, as the tissue recovered after the first day.
Other effects:
None

Any other information on results incl. tables

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Mean Response
                          1-2 h      1 d          2 d          3 d          7 d
Conjuctiva
- Redness
             0.5          0             0             0             0
- Chemosis
           0             0             0             0             0
- Discharge
           0             0             0             0             0

Cornea
- Opacity
               0             0             0             0             0
- Area
                   0             0             0             0             0

Iris
                       0             0             0             0             0

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Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Vinyl Neodeconate is not an eye irritant and does not require Classification and Labeling for this end-point based on EU Directives 67/548/EEC and 1272/2008 16 December 2008 CLP.
Executive summary:

Five adult albino rabbits were used to evaluate eye irritating properties of vinyl neodecanoate when instilled in eye. The test substance (0.1 ml undiluted) was instilled in the conjunctiva sac of the right eye. Irritation and injury to the cornea, iris, and conjunctiva were scored at 1, 24, 48, 72 hr and 7 days after the initial exposure. Based on the findings from this study,Vinyl Neodecanoate is not an eye irritant.