2-heptylcyclopentanone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 July, 1980 - 01 September, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

Deviations:

yes

Remarks:

no details on purity, no details on animal housing and environmental conditions.

Principles of method if other than guideline:

Modified Federal Hazardous Substances Labelling Act Method.

GLP compliance:

no

Test material

Test material information

1

Reference substance name:

2-heptylcyclopentanone

EC Number:

205-273-1

EC Name:

2-heptylcyclopentanone

Cas Number:

137-03-1

Molecular formula:

C12H22O

IUPAC Name:

2-heptylcyclopentan-1-one

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Unilever Environmental Safety Division, Colworth Laboratory
- Age at study initiation: 7 weeks
- Weight at study initiation: 1.9 - 2.0 kg

ENVIRONMENTAL CONDITIONS
No data.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: One eye of each animal remained untreated and served as the reference control.

Amount / concentration applied:

Amount applied: 0.1 mL

Duration of treatment / exposure:

Single instillation on Day 1

Observation period (in vivo):

5 days

Number of animals or in vitro replicates:

2 females and 1 male.

Details on study design:

STUDY DESIGN
The test material was applied undiluted in 3 animals.

TREATMENT
The substance was applied to one eye of the rabbits by gently pulling the lower lid away from the eye ball and placing 0.1 mL in the sac so formed.

REMOVAL OF TEST SUBSTANCE
-Washing: No

OBSERVATIONS
- Irritation:
The eyes were examined 24 hours after treatment and thereafter at daily intervals and graded for corneal, conjunctival and iridial damage. Eyes were examined before application of materials and at daily intervals afterwards with a slit lamp and corneal swelling is measured.
The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to OECD 405 (1981).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1 and #3

Time point:

24/48/72 h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 3

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

animal #1 and #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The substance caused slight to moderate corneal opacities in all three animals, with conjunctival swelling in two animals. All three animals had slight conjunctivitis. The observed effects were fully reversible within 4 days.

Any other information on results incl. tables

Ocular Irritant response data (for the undiluted test substance)

Animal #1	Time after administration
	15 minutes	48 hours	72 hours	4 days
Cornea score (opacity)	-	0.5	N
Iris score	-	0	0
Conjunctivae score (redness)	1	1	0
Chemosis score	1	1	0

Animal #2	Time after administration
	15 minutes	48 hours	72 hours	4 days
Cornea score (opacity)	-	1	0.5	N
Iris score	-	0	0	0
Conjunctivae score (redness)	1	1	1	0
Chemosis score	0	0	0	0

Animal #3	Time after administration
	15 minutes	48 hours	72 hours	4 days
Cornea score (opacity)	-	0.5	N
Iris score	-	0	0
Conjunctivae score (redness)	1	1	0
Chemosis score	0	0	0

N = Normal

Applicant's summary and conclusion

Interpretation of results:

other: Not an eye irritant.

Remarks:

According to Regulation (EC) No 1272/2008 and its updates.

Conclusions:

In an eye irritation study with two female and one male rabbit, performed equivalent to OECD 405 guideline, limited irritation was observed which was fully reversible within 4 days. Based on the results of this study, the substance is not considered an eye irritant.

Executive summary:

The substance was tested in an eye irritation test in two female and one male rabbit according a method/protocol equivalent to OECD 405 guideline. The substance caused slight to moderate corneal opacities in all three animals, with conjunctival swelling in two animals. All three animals had slight conjunctivitis. The observed effects were fully reversible within 4 days. The results showed that the substance is not considered an eye irritant.