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Diss Factsheets

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Stduy similar to guideline. Limited substance information (e.g. purity).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Modified Federal Hazardous Substances Labelling Act method.
Test substances are applied to one eye of each of three rabbits gently pulling the lower lid away from the eye ball and placing 0.1 mL in the sac so formed.
Modifications: Area of the cornea and iris affected was assessed as well as intensity.
Eyes are examined 24 hours after teatment and thereafter at daily intervals and graded for corneal, conjunctival and iridial damage. Eyes are examined before application of materials and at daily intervals afterwards with a slit lamp and corneal swelling is measured.
GLP compliance:
no
Remarks:
The study pre-dates the indroduction of GLP in the UK

Test material

Constituent 1
Reference substance name:
2-Pentyl cyclopent-2-enone
IUPAC Name:
2-Pentyl cyclopent-2-enone
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
6 New Zealand White rabbits waighing between 1 and 2 kg and aged between 7-9 weeks, in good general health, are used for testing each material. Only one eye of each rabbit is used. All animals are inspected with a hand torch before any treatment and those with spontaneous eye lesions are rejected. Fluorescein is appled to the eye to assist in the detection of corneal lesions. Corneal thickness is also measured before the application of test materials (Burton, 1972. Fd. Cosmet Toxicol. 10 209).

Test system

Vehicle:
other: Tween 80
Controls:
other: untreated eye of each animal was used as a control
Amount / concentration applied:
0.1 mL of undiluted test material was applied
Observation period (in vivo):
Animals are carefully watched during an immediately after application of the test material for signs of discomfort or pain.
Fifteen minutes after application of test materail the eyes are inspected for conjunctival reactions. One day after application of the test material and then at daily intervals for 5 days per week for 3 weeks or undil the eye is considered to be of normal appearance, the eyes are inspected for corneal , conjunctival and iridial reactions.
Number of animals or in vitro replicates:
Three rabbits were used in this test. Two animals were pre-treated with corneal anaesthetic.
Details on study design:
Tools used to assess score: Eyes were examined with the aid of a hand torch for corneal, conjunctival and iridial reactions.

Results and discussion

In vivo

Other effects:
No other effects reported.

Any other information on results incl. tables

2-Pentyl cyclopent-2-enone caused moderate corneal opacities, affecting up to all the cornea, in all three rabbits. These opacities were associated with slight or moderate corneal swelling. All the animals has slight conjunctivitis, one animal had slight discharge, and iritis affecting up to all the iris. All three animals developed peripheral pannus, which was still present at the end of the test. (One animal was found dead on day 15, when it still had slight corneal opactiy). All three animals showed discomfort immediately after treatment.

Applicant's summary and conclusion

Interpretation of results:
other: moderate to severe irritant
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
Under the conditions of this test 2-pentyl cyclopentenone produced a generally moderate response, though peripheral pannus was produced in all three rabbits. It is very likey to cause pain if it enters the human eye.
Executive summary:

In an in vivo study, conducted prior to the introduction of GLP or the applicable OECD test guideline, undiluted 2 -Pentyl cyclopentan-2 -enone was applied to one eye of three New Zealand White rabbits.

Under the conditions of this test 2-pentyl cyclopentenone produced a generally moderate response, though peripheral pannus was produced in all three rabbits. It is very likey to cause pain if it enters the human eye.