3-Cyclopentene-1-acetaldehyde, 2,2,3-trimethyl-, reaction products with Me Et ketone, hydrogenated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 March - 01 May 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in compliance with OECD Guideline 405 without deviation.

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

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pentan-2-ol; 6-(2,2,3-trimethylcyclopent-3-en-1-yl)hexan-3-ol

EC Number:

939-525-3

Cas Number:

1471313-03-7

Molecular formula:

C14H26O

IUPAC Name:

3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pentan-2-ol; 6-(2,2,3-trimethylcyclopent-3-en-1-yl)hexan-3-ol

Details on test material:

- Name of test material (as cited in study report): 3-METHYL-5-(2,2,3-TRIMETHYLCYCLOPENT-3-EN-1-YL)PENTAN-2-OL
- Physical state: Colourless liquid
- Analytical purity: sum of C14H26O isomers 95.4 %
- Lot/batch No.: C02030212
- Production date: 03 February 2012
- Date received: 15 February 2012
- Expiration date of the lot/batch: 02 February 2014
- Storage condition of test material: Room temperature, darkness

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome, Linxe, France
- Age at study initiation: 13 or 15 weeks
- Weight at study initiation: 2.70-3.86 kg
- Housing: Animals were housed in individual boxes.
- Diet: Food (SDS- C15), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: Approximately 15/h
- Photoperiod: 12 h dark / 12 h light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted test item

Duration of treatment / exposure:

No washing was done.

Observation period (in vivo):

21 days
Eye examinations were performed 1, 24, 48 and 72 hr post-instillation; then on days 7, 14 and 21

Number of animals or in vitro replicates:

3 females

Details on study design:

TREATMENT
- Initially, a single animal was treated. After consideration of the responses produced on Day 14 in the first treated animal, two additional animals were treated.

REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: According to OECD Guideline 405

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 21 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

Ocular reactions observed during the study have been slight to moderate and totally reversible.
- Conjunctiva: Slight redness (grade 1) noted 1 h after the test item instillation, turning into moderate redness (grade 2) at 24 h and totally reversible between Days 2 and 21, associated with a slight chemosis (grade 1) noted 1 h after the test item instillation and totally reversible between Days 3 and 14.
- Iris: Congestion (grade 1) noted 1 or 24 h after the test item instillation in two animals and totally reversible between Days 2 and 7.
- Cornea: Moderate corneal opacity (grade 2), noted 24 h after the test item instillation and totally reversible between Days 7 and 14. A corneal neovascularization was noted on Day 2 in one animal and was totally reversible on Day 14.

Other effects:

No data

Any other information on results incl. tables

Table 7.3.2/1: Results of eye irritation

 

Animal no.	A1885				A1951				A1952
	Conjunctivae		Iris	Cornea	Conjunctivae		Iris	Cornea	Conjunctivae		Iris	Cornea
	Chemosis	Redness	Lesion	Opacity	Chemosis	Redness	Lesion	Opacity	Chemosis	Redness	Lesion	Opacity
D0 (1 h)	1	1	0	0	1	1	1	0	1	1	0	0
24 h (D1)	1	2	0	2	1	2	1	2	1	2	1	2
48 h (D2)	1	1	0	2	1	0	1	2	1	0	0	2
72 h (D3)	1	0	0	2	2	2	1	2	0	0	0	2
Mean	1.0	1.0	0.0	2.0	1.3	1.3	1.0	2.0	0.7	0.7	0.3	2.0
D7	1	0	0	0	2	2	0	2	0	0	0	0
D14	0	0	0	0	0	1	0	0	-	-	-	-
D21	-	-	-	-	0	0	0	0	-	-	-	-

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 substance is classified as “R36 Irritating to eyes” according to Directive 67/548/EEC and "H319 Causes serious eye irritation" according to CLP Regulation (EC) N° 1272/2008.

Executive summary:

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy female New Zealand White rabbits were instilled 0.1 mL of undiluted test item in one eye while the other eye remained untreated and served as control. The eyelids were then gently held together for about one second to avoid any loss of test item. Eyes were examined and scored according to the method described in OECD Test Guideline 405 at 1, 24, 48 and 72 h post instillation, then on days 7, 14 and 21.

Ocular reactions were slight to moderate and totally reversible. In the conjunctivae, a slight redness was noted 1 h post instillation, turning into moderate redness at 24 h and that totally reversed between Days 2 and 21; it was associated with a slight chemosis noted 1 h post instillation that totally reversed between Days 3 and 14. In the iris, a congestion was noted 1 or 24 h post instillation in two animals that totally reversed between Days 2 and 7. In the cornea, moderate corneal opacity was noted 24 h post instillation that totally reversed between Days 7 and 14. A corneal neovascularisation was noted on Day 2 in one animal and was totally reversible on Day 14. Mean individual scores at 24, 48 and 72 h post instillation for the 3 animals were 2.0, 2.0, 2.0 for cornea score; 0.0, 1.0, 0.3 for iris score; 1.0, 1.3, 0.7 for conjunctivae score and 1.0, 1.3, 0.7 for chemosis score. The test item was thus irritant for rabbit eye in this study.

Under the test conditions, the substance is classified as “R36 Irritating to eyes” according to Directive 67/548/EEC and "H319 Causes serious eye irritation" according to CLP Regulation (EC) N° 1272/2008.