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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an U.S.E.P.A. TSCA Testing Guideline with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1. - 1.4.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Healthy young adult rabbits were obtained from J. Leslie Furs, American Fork, Utah with a body weight of 2.0 — 4.0 kg before dosing. The rabbits were acclimated for 7 days before being placed on study. The animals were Individually housed in stainless steel, wire mesh bottom cages. Animal room air was 100% fresh with not less than 10 air changes per hour. The temperature was maintained within the protocol limits of 61 — 70°F and the relative humidity ranged from 40 — 60%. Lighting was 12/12 hour, light/dark cycle. Fresh certified Agway rabbit feed was provided ad libitum and Fresh potable water was provided ad libitum.

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Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
5 male, 1 female
Details on study design:
left eye was used as control.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 and 72 hours post-treatment.
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible within: 72 hr
Irritant / corrosive response data:
At the 1 hour scoring period, conjunctival redness (Mean = 1.5), chemosis (Mean = 1.8) and discharge (Mean = 1.5) were observed in all six animals.
At the 24 hour scoring period, conjunctival redness (Mean = 0.2) and discharge (Iiean = 0.2) were observed in one of the six animals. At the 48 and 72 hour scoring periods, all animals were free of ocular lesions.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based upon the average irritation score of 0.3 calculated for the six animals using the 24 and 72 hour readings, vinyl neononanoate is considered to be a Mild Irritant under the conditions of this test.
Executive summary:

Vinyl neononanoate was evaluated for eye irritation potential by an U.S.E.P.A. O.T.S. Acute eye Irritation Testing Guideline study in compliance with the GLP regulations. Based upon the average irritation score of 0.3 calculated for the six rabbbits using the 24 and 72 hour readings, vinyl neononanoate is considered to be a Mild Irritant under the conditions of this test.