9-Decenoic acid, methyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 January 2012 to 02 February 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection 2011-07-19 to 2011-07-21; Date of signature 2011-08-31

Test material

Test material information

Constituent 1

Reference substance name:

methyl dec-9-enoate

EC Number:

662-772-0

Cas Number:

25601-41-6

Molecular formula:

C11H20O2

IUPAC Name:

methyl dec-9-enoate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.23 or 2.26 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: 2930C Teklad Global Rabbit diet available ad libitum.
- Water: Mains drinking water available ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes: at least 15 changes per hour
- Photoperiod: 12 hrs dark / 12 hrs light (06:00 to 18:00)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL of the test item was placed into the conjunctival sac of the right eye. The upper and lower lids were held close together for about 1 second immediately after treatment to prevent loss of the test item, and then released.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

One animal was treated initially. After consideration of the ocular responses produced in the first animal, two additional animals were treated.

Details on study design:

CONTROLS
The left eye remained untreated and was used for control purposes.

REMOVAL OF TEST SUBSTANCE
- Washing: none

SCORING SYSTEM: Immediately after administration of the test item, an assessment of the initial pain reaction was made according to the 6 point scale shown in Appendix 1 (see section "Attached background material"). Assessment of ocular damage/ irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment according to Draize (see Appendix 2 in section "Attached background material")

TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope

BODYWEIGHT
Individual bodyweights were recorded on Day 0 (the day of dosing) and at the end of the observation period.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(71614)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no corneal effects

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(71646)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no corneal effects

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(71647)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no corneal effects

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(71614)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no iridial effects

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(71646)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no iridial effects

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(71647)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no iridial effects

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Remarks:

(71614)

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hrs

Results 8

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Remarks:

(71646)

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 hrs

Results 9

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Remarks:

(71647)

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 hrs

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(71647)

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(71647)

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(71647)

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study.

Moderate conjunctival irritation was noted in all treated eyes one hour after treatment. Minimal conjunctival irritation was noted in all treated eyes at the 24 hour observation and in two treated eyes at the 48 hour observation.

One treated eye appeared normal at the 48 hour observation and two treated eyes appeared normal at the 72 hour observation.

The individual results are detailed in Table 2.

Other effects:

Bodyweight loss was noted in one animal and two animals showed expected gain in bodyweight during the study.

Any other information on results incl. tables

Table 2: Individual scores for ocular irritation

Rabbit number and sex	71614 Male				71646 Male				71647 Male
	IPR = 2				IPR = 2				IPR = 2
Time after treatment	1 hour	24 hours	48 hours	72 hours	1 hour	24 hours	48 hours	72 hours	1 hour	24 hours	48 hours	72 hours
Cornea Degree of opacity	0	0	0	0	0	0	0	0	0	0	0	0
Area	0	0	0	0	0	0	0	0	0	0	0	0
Iris	0	0	0	0	0	0	0	0	0	0	0	0
Conjunctivae Redness	2	1	0	0	2	1	1	0	2	1	1	0
Chemosis	2	1	0	0	2	1	0	0	2	1	0	0
Discharge	2	1	0	0	2	1	0	0	2	1	0	0

IPR = initial pain reaction

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is considered to be not irritating to the rabbit eye and is not classified in accordance with CLP Regulation No (EC) 1272/2008.