2-hexylcyclopentan-1-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-03-29 - 1982-06-14

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study similar to guideline. Limited substance information (e.g. purity).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Undiluted test substance (10 uL) was applied to one eye of each of two rabbits. Eyes were examined before administration, after 15 minutes treatment, and subsequently at daily intervals. Eyes were graded for corneal, conjunctival and iridial damage.

GLP compliance:

not specified

Remarks:

The study pre-dates the introduction of GLP in the United Kingdom.

Test material

Test material information

Constituent 1

Reference substance name:

2-n-hexylcyclopentanone

IUPAC Name:

2-n-hexylcyclopentanone

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): 2-n-hexylcyclopentanone.
- Substance type: colourless clear liquid.
- Physical state: liquid.
- Analytical purity: no data.
- Impurities (identity and concentrations): no data.
- Composition of test material, percentage of components: no data.
- Isomers composition: no data.
- Purity test date: no data.
- Lot/batch No.: 5.12974T1
- Expiration date of the lot/batch: no data.
- Stability under test conditions: no data.
- Storage condition of test material: refrigerator.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: no data.
- Age at study initiation: 8 weeks.
- Weight at study initiation: 1.6 kg (animal 1) and 1.9 kg (animal 2).
- Housing: individually caged, with no "hay, straw, or similar potentially irritant material".
- Diet (e.g. ad libitum): commercially available, pelleted diet available ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: no data.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data.
- Humidity (%): no data.
- Air changes (per hr): no data.
- Photoperiod (hrs dark / hrs light): no data.

IN-LIFE DATES: no data.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated eye of each animal used as control.

Amount / concentration applied:

10 uL of undiluted test substance applied to one eye of each animal.

Duration of treatment / exposure:

Duration of exposure not specified. Study report does not suggest that there was a rinsing step at any point.

Observation period (in vivo):

Up to 21 days. Assessments were stopped if the treated eye was judged to have returned to normal.

Number of animals or in vitro replicates:

Two.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified.
- Time after start of exposure: not specified.

SCORING SYSTEM: Please see Attachment 1.

TOOL USED TO ASSESS SCORE: Eyes were examined with the aid of a handtorch for corneal, conjunctival and iridial reactions.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

animal #1

Remarks:

Animal number 638, male, 8 weeks, 1.6 kg, treated in right eye

Time point:

other: Mean of gradings at 24, 48 and 72 hours.

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 4 days

Remarks on result:

other: Evaluation stopped after 4 days (96 hour timepoint) as eye had returned to normal.

Results 2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Remarks:

Animal number 638, male, 8 weeks, 1.6 kg, treated in right eye

Time point:

other: Mean of gradings at 24, 48 and 72 hours

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 4 days

Remarks on result:

other: Evaluation stopped after 4 days (96 hour timepoint) as eye had returned to normal.

Results 3

Irritation parameter:

chemosis score

Remarks:

conjunctivae

Basis:

animal #1

Remarks:

Animal number 638, male, 8 weeks, 1.6 kg, treated in right eye

Time point:

other: Mean of gradings at 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Some swelling was seen (graded 1/4) 15 minutes after administration. Symptoms had evidently subsided before the 24 hour timepoint.

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

Animal number 638, male, 8 weeks, 1.6 kg, treated in right eye

Time point:

other: Mean of gradings at 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: not applicable, no effects seen.

Results 5

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

animal #2

Remarks:

Animal number 640, male, 8 weeks, 1.9 kg, treated in left eye

Time point:

other: Mean of gradings at 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Evaluation stopped after 2 days (48 hour timepoint) as eye had returned to normal.

Results 6

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Remarks:

Animal number 640, male, 8 weeks, 1.9 kg, treated in left eye

Time point:

other: Mean of gradings at 24, 48 and 72 hours

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Some redness was seen (graded 1/3) 15 minutes after administration. Symptoms had evidently subsided before the 24 hour timepoint.

Results 7

Irritation parameter:

chemosis score

Remarks:

conjunctivae

Basis:

animal #2

Remarks:

Animal number 640, male, 8 weeks, 1.9 kg, treated in left eye

Time point:

other: Mean of gradings at 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Some swelling was seen (graded 1/4) 15 minutes after administration. Symptoms had evidently subsided before the 24 hour timepoint.

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

Animal number 640, male, 8 weeks, 1.9 kg, treated in left eye

Time point:

other: Mean of gradings at 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: not applicable, no effects seen.

Irritant / corrosive response data:

Corneal damage and conjunctivitis in both eyes was only very slight, with complete repair at 3 and 5 days. Thus, undiluted Jasmatone was considered to be only slightly irritant.

Other effects:

No other effects reported.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

An application (10 uL) of undiluted Jasmatone (2-n-hexyl cyclopentanone) was found to be slightly irritating to the eyes of two rabbits, with very slight corneal damage and conjunctivitis observed to be fully reversible within 3 and 5 days.

Executive summary:

In an in vivo study, conducted prior to the introduction of GLP or the applicable OECD test guideline, undiluted Jasmatone (2 -n-hexyl cyclopentanone, 10 uL) was applied to one eye each of two New Zealand White rabbits. No details on length of application were reported and there is no information in the study report on any rinsing step.

The mean scores (taken across the 24, 48 and 72 hour assessments) for corneal opacity, conjunctival redness, chemosis and iridial damage, were <1 for both animals. Very slight corneal damage and conjunctivis was reported, but was fully reversible within 3 and 5 days. Test substance considered slightly irritating.