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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Data is from experimental study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The objective of the study was to assess the irritant and/or corrosive effects of test chemical on eye, when exposed by the ocular route in rabbits.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
EC Number:
500-038-2
EC Name:
Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
Cas Number:
25322-68-3
Molecular formula:
(C2-H4-O)mult-H2-O
IUPAC Name:
Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
Details on test material:
- Name of test material (as cited in study report): Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Molecular formula :(C2-H4-O)mult-H2-O
- Molecular weight :44.0526 g/mol
- Substance type: organic
- Appearance: Colourless clear liquid
- Physical state: Liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:Procured from LIVEON BIOLABS PVT. LTD.
- Age at study initiation:2 to 3.5 Months (Approximately)
- Weight (Prior to Treatment):Minimum: 2.048 kg and Maximum: 2.168 kg (Prior to Treatment)
- Health Status : Healthy young adults rabbits were used for the study. Females were nulliparous and non pregnant.
- Housing:The animals were housed individually in stainless steel cages.
- Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle:All the cages and water bottles were changed minimum twice a week.
- Diet (e.g. ad libitum):All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences, Pune) ad libitum.
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum.
- Acclimation period:Rabbits were acclimatised to the test conditions for a period of 7 days (Animal No.-1) and 10 days (Animal No.-2 and 3) prior to the application of the test item.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 20.10 °C Maximum: 22.20 °C
- Humidity (%):Minimum: 57.20 % Maximum: 69.20 %
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12:12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 ml
- Concentration (if solution):N/A

VEHICLE
- Amount(s) applied (volume or weight with unit):N/A
- Concentration (if solution):N/A
- Lot/batch no. (if required):N/A
- Purity:N/A
Duration of treatment / exposure:
24 hrs
Observation period (in vivo):
All the animals were observed at 1, 24, 48, 72 hours and at day7 after instillation of test item.
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):The treated eye of rabbit was washed with normal saline.
- Time after start of exposure:24 hours

SCORING SYSTEM:Draize Method

TOOL USED TO ASSESS SCORE: Ophthalmoscope and fluorescent strips.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1,#2 and #3
Time point:
other: 24,48,72 hrs and 7 days
Score:
0
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Untreated (Control Eye)
Irritation parameter:
iris score
Basis:
animal: #1,#2 and #3
Time point:
other: 24,48,72 hrs and 7 days
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: Untreated (Control Eye)
Irritation parameter:
conjunctivae score
Basis:
animal: #1,#2 and #3
Time point:
other: 24,48,72 hrs and 7 days
Score:
0
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Untreated (Control Eye)
Irritation parameter:
chemosis score
Basis:
animal: #1,#2 and #3
Time point:
other: 24,48,72 hrs and 7 days
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Untreated (Control Eye)
Irritation parameter:
cornea opacity score
Basis:
animal: #1,#2 and #3
Time point:
other: After 24, 48, 72 Hours
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Treated eye
Irritation parameter:
iris score
Basis:
animal: #1,#2 and #3
Time point:
other: after 24, 48, 72 Hours
Score:
0
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Treated eye
Irritation parameter:
conjunctivae score
Basis:
animal: #1,#2 and #3
Time point:
other: 24, 48, 72 Hours
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: Treated eye
Irritation parameter:
chemosis score
Basis:
animal: #1,#2 and #3
Time point:
other: After 24, 48, 72 Hours
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Treated eye
Irritant / corrosive response data:
The following were observed in treated rabbits.
Observation at 1 hour after instillation of test item revealed: Cornea- No ulceration or opacity in all the animals; Area of Opacity- Zero in all the animals; Iris: Normal in all the animals. Conjunctivae - Some blood vessels definitely hyperaemic (injected) in all the animals; Chemosis: No swelling (Normal) were observed in all the animals.
Observation at 24 hours after instillation of test item revealed: Cornea- No ulceration or opacity in all the animals; Area of Opacity- Zero in all the animals; Iris: Normal in all the animals. Conjunctivae - Blood vessels recovered to normal in all the animals; Chemosis: No swelling (normal) was observed in all the Animals.
At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 0 %, 0% and 0% damage in Animal Nos 1, 2 and 3, respectively.
Observation at 48 and 72 hours after instillation of test item revealed: Cornea- No ulceration or opacity in all the animals; Area of Opacity- Zero in all the animals; Iris: Normal in all the animals. Conjunctivae - Blood vessels were normal in all the animals; Chemosis: No swelling (normal) was observed in all the Animals.
Untreated eye of the treated rabbits was normal throughout the experimental period of 72 hours.
The individual mean score for Animal Nos. 1, 2 and 3 at 24, 48, 72 hours for Corneal opacity, iris, conjunctiva, chemosis were found 0.00, 0.00, 0.00, 0.00 ; 0.00, 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, 0.00, respectively

Other effects:
Clinical Observation
No systemic toxicity was observed at treated rabbits during the experimental period

Mortality
No mortality was observed during the observation period.

Body weight
All rabbits were weighed on test day 0 (prior to application) and at termination. The body weights increased in all the animals as compared with pre-treatment body weight

Any other information on results incl. tables

Table 1 : Individual Animal Eye Irritation Scores

 

In Treated area Dose:100 mg of test item                                                            Sex:Female

Animal Numbers

1

2

3

Application Side

Right

Right

Right

Eye Reactions

At hour

At hour

At hour

*

1

24

48

72

*

1

24

48

72

*

1

24

48

72

Corneal Opacity

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Area of Opacity

0

0

0

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

0

0

0

Conjunctiva

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Chemosis

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Corneal Damage%

0

0

0

Dose:Untreated (Control Eye)  Sex:Female

Animal Numbers

1

2

3

Application Side

Left

Left

Left

Eye Reactions

At hour

At hour

At hour

*

1

24

48

72

*

1

 24

48

72

*

1

24

48

72

Corneal Opacity

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Area of Opacity

0

0

0

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

0

0

0

Conjunctiva

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Chemosis

0

0

0

0

0

0

0

0

0

0

0

1

0

0

0

Corneal Damage%

0

0

0

 

Key:*= Pre-exposure eye examination.

 

Table 1 Continued…

 

Eye Irritation Scores - Mean Values after 24, 48, 72 Hours (Treated eye)

            Animal No.

 Eye Reaction

1

2

3

Corneal Opacity

0.00

0.00

0.00

Iris

0.00

0.00

0.00

Conjunctiva

0.00

0.00

0.00

Chemosis

0.00

0.00

0.00

 

Formula :

 

Mean Eye Irritation Score =

                          

Sum of the Individual Animal Score for eye reactionat24, 48 and 72 hours

Number of the Observations (3)

 

  

Table 2 : Individual AnimalClinicalSigns

 

Sex:Female

Animal No.

Days (Post application observation)

0

1

2

3

1

1

1

1

1

2

1

1

1

1

3

1

1

1

1

Key:1 = Normal

 

Table 3: Individual Animal Body Weight

Sex :Female

Sex :Female

Animal No.

Animal Body Weight (kg)

Prior to application

At termination

1

2.186

2.246

2

2.048

2.148

3

2.132

2.196

Key:kg = Kilogram

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbit no. 1, 2 and 3 was observed till 72 hours which were recovered on day 7.Hence, test chemical is “Non Irritant” to New Zealand White Female rabbit eyes and is thus not classified as a eye irritant.
Executive summary:

Acute Eye Irritation/Corrosion Study of test chemical in Rabbits. This study was performed as per OECD guideline No. 405. Rabbits free from injury of eye were selected for the study. The eyes of all the rabbits were examined 24 hours prior to treatment. One eye of each rabbit served as control and other as treated. Control eye was left untreated whereas;0.1 ml of test item (as such)was instilled in the other (treated) eye of rabbits.The eye was observed at 1, 24, 48 and 72 hours after test item instillation.Ophthalmoscope was used for scoring of eye lesions. In the initial test,0.1 ml of test itemwas applied into the conjunctival sac of the right eye of Animal No.1. The left eye of the rabbit served as the control. As no severe ocular lesions were observed till 24 hour observation period, hence a confirmatory test was conducted on additional two rabbits (animal no. 2 and 3);0.1 ml of test itemwas instilled into the conjunctival sac of right eye and left eye served as the control. Ocular lesions were observed at 1 hour in animal number 2 and 3. Untreated eye of the treated rabbits was normal throughout the experimental period of 72 hours. The following grading scores were observed in treated eye of tested rabbits. Observation at 1 hour after instillation of test item revealed: Cornea-No ulceration or opacity in all the animals; Area of Opacity-Zero in all the animals;Iris:Normal in all the animals.Conjunctivae -Some blood vessels definitely hyperaemic (injected) in all the animals;Chemosis:No swelling (Normal) were observed in all the animals. Observation at 24 hours after instillation of test item revealed: Cornea-No ulceration or opacity in all the animals; Area of Opacity-Zero in all the animals;Iris:Normal in all the animals.Conjunctivae -Blood vessels recovered to normal in all the animals;Chemosis:No swelling (normal) was observed in all the Animals. At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 0 %, 0% and 0% damage in animal nos. 1, 2 and 3, respectively. Observation at 48 and 72 hours after instillation of test item revealed: Cornea-No ulceration or opacity in all the animals; Area of Opacity-Zero in all the animals;Iris:Normal in all the animals.Conjunctivae -Blood vessels were normal in all the animals;Chemosis:No swelling (normal) was observed in all the animals.The individual mean score for Animal Nos. 1, 2 and 3at 24, 48, 72 hoursfor Corneal opacity, iris, conjunctiva, chemosis were found 0.00, 0.00, 0.00, 0.00 ; 0.00, 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, 0.00, respectively. Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbit no. 1, 2 and 3 was observed till 72 hours which were recovered on day 7.Hence, test chemical is “Non Irritant” to New Zealand White Female rabbit eyes and is thus not classified as a eye irritant.