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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)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

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.