(3E)-dec-3-en-2-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-04-16 to 2009-07-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(3E)-dec-3-en-2-one

Cas Number:

18402-84-1

Molecular formula:

C10H18O

IUPAC Name:

(3E)-dec-3-en-2-one

Details on test material:

- CAS: 18402-84-1
- Purity: 98.57% to 99.11% w/w
- Batch No.: Lot KB 147-36-1
- Physical state: liquid
- Colour: Colorless to pale yellow
- Storage conditions: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Received from Robinson Services, Inc. Clemmons, NC on April 29 and May 20, 2009.
- Age at study initiation: Young adult.
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet: Pelleted Purina Rabbit Chow #5326
- Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 12 or 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 36-70
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye used as control

Amount / concentration applied:

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

Duration of treatment / exposure:

0.1 mL of the test substance was instilled into the conjunctival sac of the right eye of the first rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance.

Observation period (in vivo):

1, 24, 48 and 72 hours and day 4, 7 and 10 after instillation

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: not applicable

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: Ocular irritation was evaluated using a high-intensity white light (Mag Lite) in accordance with Draize et al.. The fluorescein dye evaluation was used in the treated eye at 24 hours to verify the absence of corneal damage.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

10 days

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.66

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

4 days

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

4 days

Irritant / corrosive response data:

One hour after test substance instillation, all three treated eyes exhibited corneal opacity and 'positive' conjunctivitis and two treated eyes exhibited iritis. The overall incide\}ce and severity of irritation decreased gradually with time. All animals were free of ocular irritation by Day 10. For detailed results please refer to table 1 in box "Any other information on results incl. tables".

Other effects:

All animals appeared active and healthy during the study. Apart from the eye irritation noted in Table 1 below there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior.

Any other information on results incl. tables

Table 1 : Eye irritation score

Animal No	Effect	Time after administration
		Hours				Days
		1	24	48	72	4	7	10
3401	Redness	2	2	1	1	1	1	0
	Chemosis	1	0	0	0	0	0	0
	Discharge	2	1	1	1	1	1	0
	Iritis	0	0	0	0	0	0	0
	Opacity	1	1*	0	0	0	0	0
	Area	2	1	4	4	4	4	4
3402	Redness	2	2	2	1	0	0	-
	Chemosis	2	0	0	0	0	0	-
	Discharge	3	2	2	1	0	0	-
	Iritis	1	0	0	0	0	0	-
	Opacity	1	0*	0	0	0	0	-
	Area	2	4	4	4	4	4	-
3403	Redness	2	2	1	1	0	0	-
	Chemosis	2	0	0	0	0	0	-
	Discharge	3	2	2	1	1	0	-
	Iritis	1	0	0	0	0	0	-
	Opacity	1	0*	0	0	0	0	-
	Area	1	4	4	4	4	4	-

* 2% ophthalmic fluorescein sodium used to verify the absence of corneal opacity.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

(3E)-dec-3-en-2-one caused irritation when applied to rabbit eyes, but does not warrant classification as an eye irritant in accordance to CLP regulation 1272/2008.

Executive summary:

In a primary eye irritation study conducted in accordance to OECD guideline 404, 0.1 mL of the test item was instilled into the conjunctival sac of the right eye of three young adult female New Zealand albino rabbits.  Animals then were observed for 10 days. Irritation was scored by the method of Draize. All animals appeared active and healthy during the study. There were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behaviour. One hour after test substance instillation, all three treated eyes exhibited corneal opacity and 'positive' conjunctivitis and two treated eyes exhibited iritis. The overall incidence and severity of irritation decreased gradually with time. All animals were free of ocular irritation by Day 10. Based on the results, no classification for eye irritation is warranted in accordance to CLP regulation 1272/2008.