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Toxicological information

Eye irritation

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Date of inspection 2011-07-19 to 2011-07-21; Date of signature 2011-08-31

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 9-decenoic acid, methyl ester (9DAME)
- Physical state: clear colourless liquid
- Analytical purity: 99%
- Lot/batch No.: 184-109
- Date received: 2011-04-01
- Storage condition of test material: room temperature in the dark under nitrogen

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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1, 2 and 3
Time point:
other: 1-72 hours
Score:
0
Remarks on result:
other: All scores were 0
Irritation parameter:
iris score
Basis:
animal: 1, 2 and 3
Time point:
other: 1-72 hours
Score:
0
Remarks on result:
other: All scores were 0
Irritation parameter:
other: conjuctivae redness score
Basis:
animal #1
Time point:
other: Mean of 24 h, 48 h and 72 h scores
Score:
0.33
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
other: conjuctivae redness score
Basis:
animal #2
Time point:
other: Mean of 24 h, 48 h and 72 h scores
Score:
0.67
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: conjuctivae redness score
Basis:
animal #3
Time point:
other: Mean of 24 h, 48 h and 72 h scores
Score:
0.67
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: conjuctivae chemosis score
Basis:
animal #1
Time point:
other: Mean of 24 h, 48 h and 72 h scores
Score:
0.33
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
other: conjuctivae chemosis score
Basis:
animal #2
Time point:
other: Mean of 24 h, 48 h and 72 h scores
Score:
0.33
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
other: conjuctivae chemosis score
Basis:
animal #3
Time point:
other: Mean of 24 h, 48 h and 72 h scores
Score:
0.33
Reversibility:
fully reversible within: 48 hours
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.