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EC number: 947-945-3 | CAS number: -
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene
- Cas Number:
- 37330-39-5
- Molecular formula:
- C(21)H(31-36)O
- IUPAC Name:
- Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: LIVEON BIOLABS PVT. LTD- Age at study initiation: 3 to 4.5 Months (Approximately)- Weight at study initiation: Minimum: 1.688 kg and Maximum: 1.788 kg (Prior to Treatment)- Housing: 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- Diet (e.g. ad libitum): All animals were provided conventional laboratory rabbit diet - 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 5 days (Animal No.-1) and 7 days (Animal No. 2 and 3) prior to the application of the test item.ENVIRONMENTAL CONDITIONS- Temperature (°C): Minimum: 19.00 °C Maximum: 20.80 °C- Humidity (%): Minimum: 46.10 % Maximum: 65.80 %- 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, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 ml
- Duration of treatment / exposure:
- 1 hr
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- Three male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing (if done): normal saline- Time after start of exposure: no dataSCORING SYSTEM: Ophthalmoscope was used for scoring of eye lesions.TOOL USED TO ASSESS SCORE: ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animal 1,2 and 3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- 14 days observation period
- Remarks on result:
- other: irritating
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Animal 1,2 and3
- Time point:
- other: 24, 48, 72
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- 14 days observation period
- Remarks on result:
- other: Irritating
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1,2 and 3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- 14 days observation period
- Remarks on result:
- other: Irritating
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal 1, 2 and 3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- 14 days observation period
- Remarks on result:
- other: Irritaing
- 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 observed 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 animal no. 1 and 3 whereas obvious swelling with partial eversion of lids was observed in animal no. 2.Observation at 24 hours after instillation of test item revealed: Cornea- No ulceration or opacity was observed 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: Obvious swelling with partial eversion of lids 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 30%, 30% and 40% damage in animal no. 1, 2 and 3 respectively. Corneal epithelium cell damage had reversed 0% in all the treated animals on at 72 hours observation period.Observation at 48 hours after instillation of test item revealed: Cornea- No ulceration or opacity was observed 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: Obvious swelling with partial eversion of lids was observed in all the animals.Observation at 72 hours after instillation of test item revealed: Cornea- No ulceration or opacity was observed 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 on day 7 after instillation of test item revealed: Cornea- No ulceration or opacity was observed 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 on day 14 after instillation of test item revealed: Cornea- No ulceration or opacity was observed in all the animals; Area of Opacity- Zero in all the animals; Iris: Normal in all the animals; Conjunctivae - Blood vessels normal was observed in all the animals; Chemosis: No swelling (Normal) was observed in all the animals.The individual mean score of treated animals for animal nos. 1, 2 and 3 at 24, 48, 72 hours (treated site) for corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 2.00, 1.67; 0.00, 0.00, 2.00, 1.67, and 0.00, 0.00, 2.00, 1.67, respectively.
- Other effects:
- Clinical ObservationNo systemic toxicity was observed in treated rabbits during the experimental period.MortalityNo mortality was observed during the observation period.Body weightBody weights were increased as compared to day 0 in all the three animals.
Any other information on results incl. tables
Table 1 : Individual Animal Eye Irritation Scores
Treated Dose:0.1 ml of as such test item Sex:Male
Animal Number | 1 | |||||||
Application Side | Right | |||||||
Eye Reactions | * | Hour(s) | Days | |||||
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 | 2 | 2 | 2 | 2 | 2 | 0 | |
Chemosis | 0 | 1 | 2 | 2 | 1 | 1 | 0 | |
Corneal Damage (%) | 0 | ./. | 30 | 20 | 0 | ./. | ./. | |
Animal Number | 2 | |||||||
Application Side | Right | |||||||
Eye Reactions | * | Hour(s) | Days | |||||
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 | 2 | 2 | 2 | 2 | 2 | 0 | |
Chemosis | 0 | 2 | 2 | 2 | 1 | 1 | 0 | |
Corneal Damage (%) | 0 | ./. | 30 | 20 | 0 | ./. | ./. | |
Animal Number | 3 | |||||||
Application Side | Right | |||||||
Eye Reactions | * | Hour(s) | Days | |||||
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 | 2 | 2 | 2 | 2 | 2 | 0 | |
Chemosis | 0 | 1 | 2 | 2 | 1 | 1 | 0 | |
Corneal Damage (%) | 0 | ./. | 40 | 30 | 0 | ./. | ./. | |
Key:*= Pre-treatment eye examination.
Untreated Dose: Control Sex:Male
Animal Number | 1 | |||||||
Application Side | Left | |||||||
Eye Reactions | * | Hour(s) | Days | |||||
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 | 0 | 0 | 0 | 0 | 0 | 0 | |
Chemosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Corneal Damage (%) | 0 | ./. | 0 | 0 | 0 | ./. | ./. | |
Animal Number | 2 | |||||||
Application Side | Left | |||||||
Eye Reactions | * | Hour(s) | Days | |||||
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 | 0 | 0 | 0 | 0 | 0 | 0 | |
Chemosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Corneal Damage (%) | 0 | ./. | 0 | 0 | 0 | ./. | ./. | |
Animal Number | 3 | |||||||
Application Side | Left | |||||||
Eye Reactions | * | Hour(s) | Days | |||||
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 | 0 | 0 | 0 | 0 | 0 | 0 | |
Chemosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Corneal Damage (%) | 0 | ./. | 0 | 0 | 0 | ./. | ./. | |
Key:*= Pre-treatment eye examination.
Table 2 : Individual AnimalClinicalSigns
Sex:Male
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
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions tested, all the three animals were fully irreversible within an observation period of 14 days. Hence under the experimental test conditions, Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene (CAS No. – 37330-39-5) is An Eye Irritant “Irritating to Eyes” of New Zealand White Male rabbit eyes and is being classified as Eye irritant 2.
- Executive summary:
Acute Eye Irritation/Corrosion Study ofCardanol (CAS No. – 37330-39-5)in Rabbits, sponsored by was conducted. This study was performed as per OECD guideline no. 405.
Observation on day 14 after instillation of test item revealed: Cornea-No ulceration or opacity was observed in all the animals;Area of Opacity-Zero inall the animals;Iris:Normal in all the animals;Conjunctivae -Blood vessels normal was observed in all the animals;Chemosis:No swelling (Normal) was observed in all the animals.
The individual mean score of treated animals for animal nos. 1, 2 and 3at 24, 48, 72 hours (treated site)for corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 2.00, 1.67; 0.00, 0.00, 2.00, 1.67, and 0.00, 0.00, 2.00, 1.67, respectively.
Under the experimental conditions tested, all the three animals were fully irreversiblewithin an observation period of 14 days.
Hence under the experimental test conditions, Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene (CAS No. – 37330-39-5)is An Eye Irritant “Irritating to Eyes” of New Zealand White Male rabbit eyes.
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