2-pentylcyclopentan-1-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From November 13 to 20, 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Basic data given: comparable to standard OECD test guideline No. 405 with the following deviations: 6 animals tested instead of 3. This deviation does not affect the reliability of this study.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Section 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38. No. 187, P. 27019, 27 September 1973

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

(6 animal tested)

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

(pre-GLP)

Test material

Test material information

Constituent 1

Reference substance name:

2-pentylcyclopentan-1-one

EC Number:

225-392-2

EC Name:

2-pentylcyclopentan-1-one

Cas Number:

4819-67-4

Molecular formula:

C10H18O

IUPAC Name:

2-pentylcyclopentan-1-one

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): P1078/2

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Healthy young albino rabbits were used.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

- Eyes of the animals were not rinsed.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: According to the "Illustrated Guide for Grading Eye Irritation by Hazardous Substance"

TOOL USED TO ASSESS SCORE: No data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3, #4, #5 & #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3, #4, #5 & #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1 & #4

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #3, #5 & #6

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #2 & #5

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 7

Irritation parameter:

chemosis score

Basis:

animal: #3 & #4

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritant / corrosive response data:

- Animals showed conjunctival reactions (redness, chemosis and discharge) which were reversible within 7 days.

Other effects:

None

Any other information on results incl. tables

Table 7.3.2/1: Eye irritation response data for each animal at each observation time

Score at time point	Cornea		Iris (/2)	Conjunctivae
	Opacity (/4)	Area (/4)		Redness (/3)	Chemosis (/4)	Discharge (/3)
1 h	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	3 / 3 / 3 / 3 / 3 / 3	3 / 3 / 3 / 3 / 3 / 3	3 / 3 / 3 / 3 / 3 / 3
24 h	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	3 / 2 / 2 / 3 / 2 / 2	3 / 2 / 3 / 3 / 2 / 3	3 / 2 / 3 / 3 / 3 / 3
48 h	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	2 / 1 / 1 / 2 / 1 / 1	2 / 1 / 2 / 2 / 1 / 2	2 / 2 / 2 / 2 / 2 / 2
72 h	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	1 / 1 / 1 / 1 / 1 / 1	1 / 1 / 2 / 2 / 1 / 0	0 / 1 / 1 / 1 / 1 / 0
Day 5	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	1 / 0 / 1 / 0 / 0 / 0	2 / 0 / 1 / 0 / 0 / 1	0 / 0 / 1 / 0 / 0 / 0
Day 7	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0
Average 24, 48 and 72 h	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	2 / 1.33 / 1.33 / 2 / 1.33 / 1.33	2 / 1.33 / 2.33 / 2.33 / 1.33 / 1.67	1.67 / 1.67 / 2 / 2 / 2 / 1.67
Reversibility	-	-	-	Completely reversible	Completely reversible	Completely reversible
Average time (unit) for reversion	-	-	-	7 days	7 days	7 days

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test material induced mild to moderate irritation being reversible within 7 days. Therefore, the test material is not classified as irritant to the eyes.

Executive summary:

In an eye irritation study performed similarly to OECD guideline No. 405, 0.1 g of undiluted test material was instilled into the right eye of 6 albino rabbits while the left eye remained untreated and served as control. The eyes were not rinsed after the instillation of test material. Animals were observed at 1, 24, 48 and 72 h after instillation of test material into eyes and then on Days 5 and 7. The reactions in the conjunctivae (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the grading system outlined in the “Illustrated Guide for Grading Eye Irritation by Hazardous material”.

The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were 2 / 1.33 / 1.33 / 2 / 1.33 / 1.33 for redness, 2 / 1.33 / 2.33 / 2.33 / 1.33 / 1.67 for chemosis, 0/0/0/0/0/0 for iris lesions and for corneal opacity.

The observed conjunctival reactions were fully reversible within 7 days. Under the test conditions, the test material is not classified as irritating to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP).

This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.