Cyclopentanol, 2-pentyl-, (1R,2S)-rel-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From June 10 to June 25, 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP study conducted according to OECD test Guideline No. 405 with minor deviations that does not affect the reliability of the study: 6 animals tested instead of 3. The study was reliable and of good quality (Klimisch score = 2). The supporting substance is considered adequate for read-across purpose (see IUCLID section 13 for additional justification). Some environmental conditions were not reported but they were assumed to be adequate because iti s a GLP 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:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

some details missing on test animals and environmental conditions but they were assumed to be adequate because it is a GLP study.

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-pentylcyclopentan-1-ol

EC Number:

283-187-3

EC Name:

2-pentylcyclopentan-1-ol

Cas Number:

84560-00-9

IUPAC Name:

2-pentylcyclopentanol

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): ST 22 C 95
- Physical state: clear liquid
- Storage conditions: ambient temperature and humidity in the container in which it was received

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gingrich Animal Suply, Frdricksbury, PA. USDA # 23-B-007.
- Age at study initiation: no data.
- Weight at study initiation: no data.
- Housing: individually housed.
- Diet: Agway Prolab High Fiber Rabbit feed and Alfalfa cubes, ad libitum.
- Water: city water ad libitum.
- Acclimation period: at least 7 days.

ENVIRONMENTAL CONDITIONS
No data

IN-LIFE DATES: no data

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 mL

Duration of treatment / exposure:

Eyes were not rinsed after instillation

Observation period (in vivo):

Observations at 1, 24, 48, 72 and on days 4, 7 and 14 after exposure.

Number of animals or in vitro replicates:

6 (Male and Female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: according to OECD 405

TOOL USED TO ASSESS SCORE: evaluated by using the "Illustrated Guide for Grading Eye Irritation by Hazardous Substances".

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

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

Time point:

other: mean 24, 48, 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

animal #4

Time point:

other: mean 24, 48, 72 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 3

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

animal #6

Time point:

other: mean 24, 48, 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results 4

Irritation parameter:

iris score

Basis:

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

Time point:

other: mean 24, 48, 72 hours

Score:

0

Max. score:

2

Results 5

Irritation parameter:

iris score

Basis:

animal #4

Time point:

other: mean 24, 48, 72 hours

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 4 days

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal: #1 & #5

Time point:

other: mean 24, 48, 72 hours

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean 24, 48, 72 hours

Score:

2.67

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean 24, 48, 72 hours

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

other: mean 24, 48, 72 hours

Score:

2.33

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

other: mean 24, 48, 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal: #1& #5

Time point:

other: mean 24, 48, 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean 24, 48, 72 hours

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 13

Irritation parameter:

chemosis score

Basis:

animal: #3 & #4

Time point:

other: mean 24, 48, 72 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 14

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

other: mean 24, 48, 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 2 days

Irritant / corrosive response data:

The test material produced minimal conjunctival irritation (6/6) and chemosis (4/6) one hour post-instillation.
24 hours post instillation, corneal opacity in 6/6 animals and positive conjunctival irritation in 5/6 and positive chemosis in 3/6 animals. Iritis was observed in 1/6 animals on day 3 of the study.
On study day 7, there were no corneal opacities observed. Four animals had minimal conjunctival irritation. Three animals had minimal chemosis. No iritis was observed. All irritation cleared by day 14, therefore the study was terminated at that point.

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)
24 h (Day 1)	1 / 1 / 1 / 1 / 1 / 1	3 / 3 / 3 / 3 / 3 / 1	0 / 0 / 0 / 0 / 0 / 0	2 / 2 / 2 / 2 / 2 / 1	1 / 2 / 2 / 2 / 1 / 1	2 / 2 / 2 / 2 / 1 / 1
48 h (Day 2)	1 / 1 / 1 / 1 / 1 / 0	1 / 3 / 2 / 2 / 1 / 0	0 / 0 / 0 / 0 / 0 / 0	1 / 3 / 2 / 3 / 1 / 1	1 / 3 / 2 / 2 / 1 / 0	1 / 3 / 2 / 2 / 1 / 1
72 h (Day 3)	1 /1 / 1 / 0 / 1 / 0	1 / 3 / 1 / 0 / 1 / 0	0 / 0 / 0 / 1 / 0 / 0	1/ 3 / 2 / 2 / 1 / 1	1 / 3 / 2 / 2 / 1 / 0	1 / 3 / 2 / 2 / 1 / 0
Average 24h, 48h, and 72h	1 / 1 / 1 / 0.67 / 1 / 0.33	1.67 / 3 / 2 / 1.67 / 1.67 / 0.33	0 / 0 / 0 / 0.33 / 0 / 0	1.33 / 2.67 / 2 / 2.33 / 1.33 / 1	1 / 2.67 / 2 / 2 / 1 / 0.33	1.33 / 2.67 / 2 / 2 / 1 / 0.67
Reversibility	Completely reversible	Completely reversible	Completely reversible	Completely reversible	Completely reversible	Completely reversible
Average time (unit) for reversion	7 days	7 days	4 days	14 days	14 days	14 days

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test material is classified as irritating to eyes (category 2) according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP) based on 4/6 animals having a cornea score of 1 which fully reverses within 7 days.

Executive summary:

In an eye irritation study performed according to the OECD guideline No. 405, 0.1 mL of undiluted test material was instilled into the eye of 6 New Zealand White Rabbit. The eyes were not rinsed after the instillation of the test item.The contralateral eye of each rabbit served as control. Animals were observed at 1, 24, 48 and 72 hours, and 4, 7 and 14 days after dosing. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale. 

 

The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were 1.33 / 2.67 / 2 / 2.33 / 1.33 / 1 for redness, 1 / 2.67 / 2 / 2 / 1 / 0.33 for chemosis, 0 / 0 / 0 / 0.33 / 0 / 0 for iris lesions and 1 / 1 / 1 / 0.67 / 1 / 0.33 for corneal opacity. 4/ 6 rabbits show a mean score per animal ≥ 1 for corneal opacity. All the reactions were fully reversible within 14 days. 

Under the test conditions, the test material is classified as irritating to eyes (category 2) according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP) based on 4/6 animals having a cornea score of 1 which fully reverses within 7 days.

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