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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:
27-03-2014 to 17-04-2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP. All relevant validity criteria were met.
Justification for type of information:
Information as to the availability of the in vivo study is provided in 'attached justification'.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Reaction mass of (4E,8Z)-cyclododeca-4,8-dien-1-one and (4Z,8E)-cyclododeca-4,8-dien-1-one and (4E,8E)-cyclododeca-4,8-dien-1-one
EC Number:
941-893-5
Cas Number:
15229-79-5
Molecular formula:
C12H18O
IUPAC Name:
Reaction mass of (4E,8Z)-cyclododeca-4,8-dien-1-one and (4Z,8E)-cyclododeca-4,8-dien-1-one and (4E,8E)-cyclododeca-4,8-dien-1-one
Test material form:
liquid
Details on test material:
- Physical state: Liquid
- Storage condition of test material: Keep in the dark at 0 - 10 °C, under nitrogen
- Other: Colourless

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Recognised Supplier
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.31 - 2.53 kg
- Housing: individually housed in suspended metal cages; with environment enrichment
- Diet: certified rabbit food ad libitum
- Water: mains water ad libitum
- Acclimation period: at least 5 days

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye remained untreated
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
A volume of 0.1 mL of the test material, was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes.
Observation period (in vivo):
Ocular assessment was conducted at approximately 1, 24, 48 and 72 hours after instillation of the test item, according to numerical evaluation.
Number of animals or in vitro replicates:
3 (female). Testing was conducted sequentially following testing with a sentinel.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM:
The irritation was assessed according to Draize (1977) numerical scoring system. At each observation period, the highest scores given were recorded. Any other ocular effects were also noted.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Diffuse corneal opacity (score = 1) was noted in one treated eye after 24 h.
Iridial inflammation (score = 1) was noted in two treated eyes 1 h after treatment, at the 24 and 48 h observations and persisted in one treated eye at the 72 h observations.
Moderate conjunctival irritation (score = 2) was noted in all treated eyes 1 h after treatment, two treated eyes at the 24 h observation and one treated eye at the 72 h observation. In two treated eyes this had fully reversed by 72 hours (score = 0).
All treated eyes appeared normal at day 14 (score = 0).
Other effects:
One animal showed a slight body weight loss, although this was considered to be within the normal variation for this species/strain, and two animals showed expected gain in body weight during the study.

Any other information on results incl. tables

Table 1. Individual scores and mean scores for 24, 48 and 72 hours

Number and Sex

1 Female

2 Female

3 Female

 

1 hour

24 hours

48 hours

72 hours

7 days

14 days

1 hour

24 hours

48 hours

72 hours

7 days

14 days

1 hour

24 hours

48 hours

72 hours

7 days

14 days

Cornea

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Opacity

0

0

0

0

0

0

0

0

0

0

-

-

0

1

0

0

-

-

Mean (24 – 72 h)

 

 

 

0

 

 

 

 

 

0

 

 

 

 

 

0.3

 

 

Iris

1

1

1

1

0

0

0

0

0

0

-

-

1

1

1

0

-

-

Mean (24 – 72 h)

 

 

 

1.0

 

 

 

 

 

0

 

 

 

 

 

0.7

 

 

Conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Redness

2

2

2

2

1

0

2

2

1

0

-

-

2

2

1

0

-

-

Mean (24 – 72 h)

 

 

 

2.0

 

 

 

 

 

1.0

 

 

 

 

 

1.0

 

 

Chemosis

2

2

2

1

1

0

2

1

0

0

-

-

2

2

1

0

-

-

Mean (24 – 72 h)

 

 

 

1.7

 

 

 

 

 

0.3

 

 

 

 

 

1.0

 

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the test item is not irritating to the eye.
Executive summary:

The study was performed to OECD TG 405 and EU Method B.5 to assess the irritancy potential of the test material to the eye following a single application in the New Zealand White rabbit. A volume of 0.1 ml of the test material was placed into the conjunctival sac of one eye of two animals. The other eye remained untreated and was used for control purposes. The test was conducted in a stepwise manner conducted singularly in accordance with the guideline. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. A single application of the test material to the non-irrigated eye of two rabbits produced diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation. Two treated eyes appeared normal at the 72-Hour observation and one treated eye appeared normal at the 14-Day observation. Under the conditions of this study, the test item is not considered to be irritating to the eye.