Oxazolidine, 3-butyl-2-(1-ethylpentyl)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-04-15 to 1997-04-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

February 24th 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

July 31st 1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-660-0

EC Name:

-

Cas Number:

165101-57-5

Molecular formula:

C14H29NO

IUPAC Name:

3-butyl-2-(heptan-3-yl)-1,3-oxazolidine

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Ltd, Margate
- Age at study initiation: 11-14 weeks
- Weight at study initiation: 2.44-2.60 kg
- Housing: individually in floor-pens (floor area 0.6 m2)
- Diet: SQC TRB Rabbit Diet 9603 (pelleted), ad libitum
- Water: mains water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 40-80
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

4 days (condition of the treated eye was confirmed normal on day 4)

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

SCORING SYSTEM:

Cornea - degree of opacity (area most dense assessed)

No ulceration or opacity 0
Scattered or diffuse areas of opacity other than
slight dulling of normal lustre, details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible but size of pupil barely discernible 3
Opaque cornea, iris not discernible through opacity 4

Cornea - area of corneal opacity

Total area of opacity amounts to <25% of corneal area 1
Area of opacity amounts to 25-<50% of corneal area 2
Area of opacity amounts to 50- < 75 % of corneal area 3
Area of opacity amounts to 75 % or more of corneal area 4

Iris Grade

No reaction 0
Markedly deepened rugae, congestion, swelling, moderate
circumcorneal hyperaemia or injection, any of these or any
combination thereof; iris still reacting to light 1
No iridial reflex to light, haemorrhage or gross destruction
(any or all of these) 2

Conjunctivae - redness

Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red appearance 3

Conjunctivae - Chemosis

No swelling 0
Any swelling above normal 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half-closed 3
Swelling with lids more than half-closed 4

Conjunctivae - discharge

No discharge 0
Any discharge greater than normal, not including the small
amount normally present in the inner canthus 1
Discharge with moistening of eyelids and hairs just
adjacent to the eye 2
Discharge with moistening of eyelids and hair for a
considerable area around the eye 3

TOOL USED TO ASSESS SCORE: The treated eyes were examined visually and, where appropriate, with the aid of a device to illuminate or magnify the eye.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Instillation of Incozol 2 elicited a slight initial sting response from the sentinel rabbit but practically no reaction from the other two animals. Injection of the conjunctival vasculature was apparent in all three rabbits during the initial four hour observation period following instillation with a slight ocular discharge also produced in this period. The eyes of all rabbits were overtly normal by the 24 hour examination.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the findings in this eye irritation study on New Zealand white rabbits, Incozol 2 is not irritating to the eye.

Executive summary:

This study was conducted to determine the irritation caused to the rabbit eye following a single instillation of Incozol 2 into the conjunctival sac. The method followed was in compliance with that described in EU Method B5 and OECD TG 405. The undiluted test article (0.1 mL) was instilled into one conjunctival sac of each of three New Zealand White rabbits. Ocular reactions were assessed for three days after treatment. Instillation of Incozol 2 elicited a slight initial sting response from the sentinel rabbit but practically no reaction from the other two animals. Injection of the conjunctival vasculature was apparent in all three rabbits during the initial four hour observation period following instillation with a slight ocular discharge also produced in this period. The cornea and iris were overtly unaffected by treatment. The eyes of all rabbits were overtly normal by the 24 hour examination. Therefore the tested substance was regarded as non irritating to the eye (Covance, 1997).