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EC number: 256-905-8 | CAS number: 51000-52-3
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:
- 2 007
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
- 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.
Constituent 1
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.
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