4-pentylcyclohexanone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 12 until February 26, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted February 24, 1987

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-pentylcyclohexanone

EC Number:

406-670-4

EC Name:

4-pentylcyclohexanone

Cas Number:

61203-83-6

Molecular formula:

C11H20O

IUPAC Name:

4-pentylcyclohexan-1-one

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: SAVO-lvanovas, Kisslegg
- Age at study initiation: 15 - 16 weeks
- Weight at study initiation: mean 2.73 (2.66 - 2.80) kg
- Housing: kept separately in cages type KK 017
- Diet: ad libitum, acidified, fully demineralized water from an automatic drinking device
- Water: ad libitum, Altromin Standard Diet TPF 2113
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 38-56
- Photoperiod (hrs dark / hrs light):12/12

To ensure that only rabbits without ocular abnormalities were included in the study, 24 hours before treatment ophthalmological examinations were performed after instillation of 0.15 % fluorescein solution using an ophthalmoscope after Eisenhut.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 (1m and 2f)

Details on study design:

The rabbits were investigated for eye irritation and for changes in behavior and general condition 1 hour after treatment and then daily for a period of further 7 days. All rabbits were weighed before the start of the study and on days 5 and 8.

- Washing: no

SCORING SYSTEM: Local changes of the eye were evaluated according to the recommendations of the OECD

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 3 days

Results 4

Irritation parameter:

other: discharge

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 2 days

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 3 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 8

Irritation parameter:

other: discharge

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 2 days

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 2 days

Results 12

Irritation parameter:

other: discharge

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 1 day

Results 13

Irritation parameter:

chemosis score

Basis:

animal: #1-3

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Other effects:

- Ophthalmoscopic findings:
No irritation of the cornea was observed. At one reading (animal No. 90013, day 3) congestion of the iris was observed. Examination of the conjunctivae revealed redness and discharge beginning at the first reading up to day 4, maximally.

- Other observations:
No signs of systemic toxicity were seen. The body weight development was normal. All animals survived the 8 day observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the results of this study the test material is not to be classified as an irritant for eyes.

Executive summary:

A study was performed according to OECD 405 under GLP conditions. To test for primary eye irritation the test item was instilled into the conjunctival sac of rabbits (left eye). The right eye served as untreated control. The first examination of the eyes was performed 1 hour after instillation. Then examinations were performed daily for 7 days. In the primary eye irritation test no irritation of the cornea was observed. Congestion of the iris (value 1) was seen in one rabbit on day 3. The conjunctivae showed redness and discharge at the first reading up to day 4, maximally.The test item is not requiring classification for skin irritation according to (EC) No 1272/2008.