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 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
Test material form:
other: Liquid at room temperature.
Details on test material:
As per 2,3-Epoxypropyl neodecanoate IUCLID 4 Data Set, Section 1-1.4, 2003.

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 examined and weighed on the day of arrival. The animals weighed between 1.8 to 2.6 kg when placed on study and were 8 to 14 weeks old. Rabbits were housed in floor-pens, each accommodating one animal throughout the acclimatisation and experimental phases of the study. Each pen had a minimum floor area of 0.6 sq m. Wood chips were provided as floor litter. Each batch of wood chips was analysed for specific contaminants.

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. No contaminants were present in diet, bedding or water at levels which might interfere with achieving the objective of the study.

The holding room was designed to permit at least 10 air changes per hour and to maintain environmental conditions of 16 to 22°C. Humidity was not actively controlled but was expected to remain within the range 40-80% Relative Humidity. Recordings of maximum and minimum temperature and humidity were made twice daily and any minor deviations from the expected ranges were noted in the study data. The room was illuminated by fluorescent strip-lights for twelve hours daily (typically 06:00 to 18:00 hours).

The condition of the animals was assessed daily throughout an acclimatisation period of at least one week. A clinical inspection was performed prior to study commencement to ensure the animals were suitable for the test procedures. Healthy animals, weighing not more than 4.0 kg, were arbitrarily allocated to the study on the day before dosing. Both eyes of each rabbit were examined for indications of corneal, india! or conjunctival damage or irritation.



Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml undiluted
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Right eye was used as control.

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 and 4 hours
Score:
0.7
Max. score:
0.7
Reversibility:
fully reversible
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. The Group Mean one and four hour Conjuntival Redness score was 0.7. The Group Mean four hour Chemosis score was 0.3. No other signs of eye irritation were observed during the study.


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:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Instillation of 2,3-epoxypropyl neodecanoate 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 substance. Therefore, under the conditions of this study, the test substance was considered to be a non-irritant to the rabbit eye.




Executive summary:

2,3 -Epoxypropyl neodecanoate was evaluated for eye irritation potential in an O.E.C.D. 405 Testing guideline study following the GLP regulations. Instillation of 0.1 mL 2,3-epoxypropyl neodecanoate 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, under the conditions of this study, the test substance was considered to be a non-irritant to the rabbit eye.