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 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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-epoxypropyl o-tolyl ether
EC Number:
218-645-3
EC Name:
2,3-epoxypropyl o-tolyl ether
Cas Number:
2210-79-9
Molecular formula:
C10H12O2
IUPAC Name:
2-[(2-methylphenoxy)methyl]oxirane
Constituent 2
Reference substance name:
Oxirane, 2-[(2-methylphenoxy)methyl]-
IUPAC Name:
Oxirane, 2-[(2-methylphenoxy)methyl]-
Details on test material:
As per IUCLID Sections 1.1. 1.2. and 4.1.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The rabbits were acquired from Kleintierfarm Madoerin AG CH 4414 ruellinsdorf / Switzerland and were 14-15 weeks of age with a body weight range of 2.6-2.8 Kg. They were housed individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik). The Standard Laboratory Conditions were: Air-conditioned with 10—15 air changes pe hour and hourly monitored environment with temperature 20+/—3 degrees centigrade, relative humidity of 40—70 % and 12 hours artificial fluorescent light/12 hours
dark, light period. The animals were offered pelleted standard Kliba 341, rabbit maintenance diet (“Kliba”, Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) and water ad libitum.



Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL neet
Duration of treatment / exposure:
72 hr
Observation period (in vivo):
72 hr
Number of animals or in vitro replicates:
3
Details on study design:
The test substance (0.1 ml per animal) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for approximately one second to prevent loss of the test substance. The right eye remained untreated and served as the reference control.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1hr-72 hr.
Score:
ca. 0.58
Reversibility:
fully reversible
Irritant / corrosive response data:
Two test animals had a Conjunctival Redness score of 0.33 over the 24-72 hr observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test substance is not irritating to the rabbit eye under the conditions of the study.
Executive summary:

The test substance, 2,3 -epoxypropyl o-tolyl ether was accesed for eye irritation potential in an O.E.C.D. test guideline no. 405 study.The test substance was not irritating to the rabbit eye under the conditions of the study.