Registration Dossier

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 the O.E.C.D. test guideline 405 with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Colorless liquid at room temperature.
Details on test material:
As per IUCLID5 Sections 1.1. 1.2. 1.4. and 4.1. for 2,3-epoxypropyl neodecanoate, REACH Registration: 01-2119431597-33-0000.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
New Zealand White rabbits of the Crl:NZW/Kbl.BR strain were obtained from Charles River UK Ltd, Margate. The animals were eight to ten weeks old on study Day 1 and weighted approximately 1.8 - 2.6 kg. Rabbits were housed in floor-pens, each accommodating one animal throughout the acclimatisation and experimental phases of the study. Wood chips were provided as floor litter.

The animal holding room was designed to permit at least 10 air changes per hour and to maintain environmental conditions of 16 to 22°C and approximately 40-80% Relative Humidity. The room was illuminated by fluorescent strip-lights for twelve hours daily (typically 06:00 to 18:00 hours).

SQC TRB Rabbit Diet 9603 (pelleted) from Harlan Tekiad, Bicester was freely available to the animals at all times. Each batch of diet had been analysed for specific constituents. Mains water was provided, ad libitum, via water bottles attached to the pen walls. The water had been periodically analysed for specific contaminants.



Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
3 days
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
3
Details on study design:
One dose consisting of 0.1 mL of undiluted test substance, dispensed from a syringe, was instilled into the left conjunctival sac of the New Zealand White rabbits The lower eyelid was gently prised away from the eyeball to create a receptacle for the dose. After instillation the eyelids were held closed for a few seconds to prevent loss of the dose. The right eye remained untreated and served as a control to the treated eye. The day of dosing was designated as Day 1. The condition of the treated eyes were assessed for a period of at least three days to ensure the test substance did not cause ocular damage. Ocular changes were assessed and recorded immediately, half an hour, one and four hours after treatment on Day 1 and 24, 48 and 72 hours after dosing.

At examinations carried out 24 hours after treatment, 2% aqueous fluorescein solution was applied to the cornea and then washed out with water for irrigation. The comeal surface was then illuminated by an ultraviolet source and inspected for areas of absorption of the fluorescing dye that indicate epithelial disruption.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
of 3 animals.
Time point:
other: one hr
Score:
ca. 0.7
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
of three animals.
Time point:
other: 4 hr
Score:
ca. 0.7
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of three animals.
Time point:
other: 4 hr
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Irritant / corrosive response data:
Reactions in one rabbit eye were resricted to slight conjunctival reddening and production of an ocular discharge immediately after dosing but these reactions had resolved half an hour later. For the other two rabbits conjunctival redness persisted to the four hour post dosing assessment but had resolved by Day 2. The presence of a slight discharge from the eye was noted for both animals on Day I and the conjunctivae for one rabbit were slightly swollen. No iridial or corneal changes were apparent in any of the three treated eyes.


Other effects:
No observations indicative of systemic toxicity or ill health were noted for any rabbits during the course of the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Instillation of the test substance into the conjunctival sac of three rabbits caused transient conjunctival changes that resolved within 24 hours. The iris and cornea were overtly unaffected by instillation of the test article. Therefore, the test substance is not an eye irritant.
Executive summary:

The test substance, 2,3-epoxypropyl neodecanoate was accessed for eye irritational potential in an O.E.C.D. test guideline 405 study. Instillation of the test substance into the conjunctival sac of three rabbits caused transient conjunctival changes that resolved within 24 hours. The iris and cornea were overtly unaffected by instillation of the test article. Therefore, the test substance is not an eye irritant. It is anticipated that Neononanoic acid glycidyl ester will also be a non-eye irritant.