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EC number: 500-002-6 | CAS number: 9002-92-0 1 - 2.5 moles ethoxylated
Eye irritation
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 the experimental reports
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- 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 the test chemical on eye, when exposed by the ocular route in rabbits.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dodecan-1-ol, ethoxylated
- EC Number:
- 500-002-6
- EC Name:
- Dodecan-1-ol, ethoxylated
- Cas Number:
- 9002-92-0
- Molecular formula:
- C58H118024
- IUPAC Name:
- Dodecan-1-ol, ethoxylated
- Test material form:
- liquid
- Details on test material:
- Identification: Dodecan-1-ol, ethoxylated
Appearance : Colourless clear liquid
AI Content: 99.28%
Storage conditions: Room temperature (20 - 30 °C)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species : Rabbit (Oryctolagus cuniculus)
Strain : New Zealand White
Age : 2.0 to 4.0 Months (Approximately)
Sex : Female
Number of Animals :Three
Supplier/Source :Procured from SAINATH AGENCIES
Health Status :Healthy young adult rabbits were used. Females were nulliparous and non pregnant.
Body weight of animals: Minimum: 1.648 kg and Maximum: 1.752 kg (Prior to Treatment)
Acclimatisation 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.
Identification:During acclimatization marking was done with non toxic marker pen in the inside of left ear of rabbits and after acclimatization, animals were marked with permanent number in the inner side of right ear of rabbits. Permanent marker and cage card was used for identification. The individual cage card was labelled with at least study no., study type, test system, sex, dose, experiment start date and experiment completion date.
Diet:All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No.: 200005 and 200006.
Water:Aqua guard filtered tap water was provided ad libitum.
Husbandry: 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.
Experimental Room Condition
Temperature : Minimum: 19.60 °C Maximum: 22.20 °C
Relative humidity : Minimum: 56.50 % Maximum: 69.20 %
Light-dark-rhythm : 12:12
Air Changes: More than 12 changes per hour
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml test item (as such) was placed in the conjunctival sac of three rabbits
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- All the animals were observed at 1, 24, 48, 72 hours,on day 7 and day 14 after instillation of test item.
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- three 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: hand-slit lamp / biomicroscope / fluorescein: Treated and control eyes of rabbits were examined with the help of ophthalmoscope at one hour after instillation of test item
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: animal: #1,#2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- other: animal: #1,#2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- other: animal: #1and #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- other: animal: #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- other: animal: #1 and #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- 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 was seen 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: Some swelling above normal (includes nictitating membranes) in all the animals.
Observation at 24 hours after instillation of test item revealed: Cornea- No ulceration or opacity was seen 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) was seen in animal no. 1 and 2 whereas diffuse, crimson color; individual vessels not easily discernible was seen in animal no. 3. Chemosis: Some swelling above normal (includes nictitating membranes) was seen in all the animals.
At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 30%, 20% and 30% damage in animal no. 1, 2 and 3 respectively.
Observation at 48 hours after instillation of test item revealed: Cornea- No ulceration or opacity was seen in all the animals; Area of Opacity- Zero in all the animals; Iris: Normal in all the animals; Conjunctivae - Diffuse, crimson color; individual vessels not easily discernible was observed in all the animals; Chemosis: Some swelling above normal (includes nictitating membranes) was observed in all the animals.
Observation at 72 hours after instillation of test item revealed: Cornea- No ulceration or opacity was seen in all the animals; Area of Opacity- Zero in all the animals; Iris: Normal in all the animals; Conjunctivae - Diffuse, crimson color; individual vessels not easily discernible was observed in all the animals; Chemosis: Some swelling above normal (includes nictitating membranes) was seen in animal no. 1 and 3 whereas obvious swelling with partial eversion of lids was seen in animal no.2.
Observation on day 7 after instillation of test item revealed: Cornea- No ulceration or opacity was seen in all the animals; Area of Opacity- Zero in all the animals; Iris: Normal in all the animals; Conjunctivae - Diffuse, crimson color; individual vessels not easily discernible was seen in animal no. 1 and 2 whereas some blood vessels definitely hyperaemic (injected) was seen animal no. 3; Chemosis: Some swelling above normal (includes nictitating membranes) was seen in all the animals.
Observation on day 14 after instillation of test item revealed: Cornea- No ulceration or opacity was seen in all the animals; Area of Opacity- Zero in all the animals; Iris: Normal in all the animals; Conjunctivae - Blood vessels normal in all the animals; Chemosis: No swelling (Normal) in all the animals.
The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 1.67, 1.00; 0.00, 0.00, 1.67, 1.33, and 0.00, 0.00, 2.00, 1.00, respectively. - Other effects:
- Clinical Observation
No systemic toxicity was observed in treated rabbits during the experimental period (Refer Table 2).
Mortality
No mortality was observed during the observation period.
Body weight
Increase in body weights of all the animals weighed on test day 0 (prior to application) and at termination
Any other information on results incl. tables
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 |
1.67 |
1.67 |
2.00 |
Chemosis |
1.00 |
1.33 |
1.00 |
Table 2 : Individual AnimalClinicalSigns
Sex:Female
Animal No. |
Days (Post application observation) |
||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Key:1 = Normal
Table 1 : Individual Animal Eye Irritation Scores
Treated Dose:0.1 ml of test item (as such, undiluted) Sex:Female
Animal Number |
1 |
||||||
Application Side |
Right |
||||||
Eye Reactions |
* |
Hour(s) |
Day |
||||
1 |
24 |
48 |
72 |
7 |
14 |
||
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctiva |
0 |
1 |
1 |
2 |
2 |
2 |
0 |
Chemosis |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
Corneal Damage (%) |
30 |
||||||
Animal Number |
2 |
||||||
Application Side |
Right |
||||||
Eye Reactions |
* |
Hour(s) |
Day |
||||
1 |
24 |
48 |
72 |
7 |
14 |
||
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctiva |
0 |
1 |
1 |
2 |
2 |
2 |
0 |
Chemosis |
0 |
1 |
1 |
1 |
2 |
1 |
0 |
Corneal Damage (%) |
20 |
||||||
Animal Number |
3 |
||||||
Application Side |
Right |
||||||
Eye Reactions |
* |
Hour(s) |
Day |
||||
1 |
24 |
48 |
72 |
7 |
14 |
||
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctiva |
0 |
1 |
2 |
2 |
2 |
1 |
0 |
Chemosis |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
Corneal Damage (%) |
30 |
||||||
Key:*= Pre-treatment eye examination.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 1.67, 1.00; 0.00, 0.00, 1.67, 1.33, and 0.00, 0.00, 2.00, 1.00, respectively.Under the experimental conditions tested, all the three animals were fully reversible within an observation period of 14 days.
Hence under the experimental test conditions,the test chemical was “An Eye Irritant (Irritating to Eyes)" to New Zealand White Female rabbit eyes. it was classified under the category "Category 2" as per Globally Harmonized System of Classification and Labelling of Chemicals (GHS) classification. - Executive summary:
Acute eye irritation/corrosion study was conducted in rabbits to evaluate the eye irrritant nature of the test chemical. The study was performed as per OECD 405 Guidelines using 3 female New Zealand White rabbits.
Rabbitsfree 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 mlof test itemwas instilled in the other (treated) eye of each rabbit.The eye was observed at 1, 24, 48, 72 hour, day 7 and day 14 for all the animals after test item instillation.Ophthalmoscope was used for scoring of eye lesions.
In the initial test,0.1 ml of test item (as such, undiluted)was applied into the conjunctival sac of the right eye of animal no.1 whereas the left eye of the rabbit served as the control. As animal no. 1 showed no severe ocular lesions a confirmatory test was conducted on additional two rabbits (animal no. 2 and 3); 0.1 mlof test itemwas instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control.
Untreated eye of all the three rabbits were normal throughout the experimental period.
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 was seen in all the animals;Area of Opacity-Zero inall the animals;Iris:Normal in all the animals;Conjunctivae -Some blood vessels definitely hyperaemic (injected) in all the animals;Chemosis:Some swelling above normal (includes nictitating membranes) in all the animals.
Observation at 24 hours after instillation of test item revealed: Cornea-No ulceration or opacity was seen in all the animals;Area of Opacity-Zero inall the animals;Iris:Normal in all the animals;Conjunctivae -Some blood vessels definitely hyperaemic (injected) was seen in animal no. 1 and 2 whereas diffuse, crimson color; individual vessels not easily discernible was seen in animal no. 3.Chemosis:Some swelling above normal (includes nictitating membranes) was seen in all the animals.
At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 30%, 20% and 30% damage in animal no. 1, 2 and 3 respectively.
Observation at 48 hours after instillation of test item revealed: Cornea-No ulceration or opacity was seen in all the animals;Area of Opacity-Zero inall the animals;Iris:Normal in all the animals;Conjunctivae - Diffuse, crimson color; individual vessels not easily discernible was observed in all the animals;Chemosis:Some swelling above normal (includes nictitating membranes) was observed in all the animals.
Observation at 72 hours after instillation of test item revealed: Cornea-No ulceration or opacity was seen in all the animals;Area of Opacity-Zero inall the animals;Iris:Normal in all the animals;Conjunctivae - Diffuse, crimson color; individual vessels not easily discernible was observed in all the animals;Chemosis:Some swelling above normal (includes nictitating membranes) was seen in animal no. 1 and 3 whereas obvious swelling with partial eversion of lids was seen in animal no.2.
Observation on day 7 after instillation of test item revealed: Cornea-No ulceration or opacity was seen in all the animals;Area of Opacity-Zero inall the animals;Iris:Normal in all the animals;Conjunctivae - Diffuse, crimson color; individual vessels not easily discernible was seen in animal no. 1 and 2 whereas some blood vessels definitely hyperaemic (injected) was seenanimal no. 3;Chemosis:Some swelling above normal (includes nictitating membranes) was seen in all the animals.
Observation on day 14 after instillation of test item revealed: Cornea-No ulceration or opacity was seen in all the animals;Area of Opacity-Zero inall the animals;Iris:Normal in all the animals;Conjunctivae -Blood vessels normal in all the animals;Chemosis:No swelling (Normal) in all the animals.
The individual mean score for animal nos. 1, 2 and 3at 24, 48, 72 hoursfor corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 1.67, 1.00; 0.00, 0.00, 1.67, 1.33, and 0.00, 0.00, 2.00, 1.00, respectively.
Under the experimental conditions tested, all the three animals were fully reversiblewithin an observation period of 14 days. Hence under the experimental test conditions,the test chemical was “An Eye Irritant (Irritating to Eyes)" to New Zealand White Female rabbit eyes. it was classified under the category "Category 2" as per Globally Harmonized System of Classification and Labelling of Chemicals (GHS) classification.
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