Vinyl neodecanoate

Eye irritation

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

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

Test material information

Constituent 1

Reference substance name:

Vinyl neodecanoate

EC Number:

256-905-8

EC Name:

Vinyl neodecanoate

Cas Number:

51000-52-3

Molecular formula:

C12H22O2

IUPAC Name:

vinyl neodecanoate

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.