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Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Species:Rabbit (Oryctolagus cuniculus)Strain:New Zealand White Age :4 to 5 Months (Approximately)Sex:MaleNumber of Animals:ThreeSupplier/Source:Procured from GENTOX BIOSERVICES PVT. LTDHealth Status:Healthy young adult rabbits were used for the studyBody weight of animals: Minimum: 1.782 kg & Maximum: 2.168 kg (Prior to Treatment)Acclimatisation:Rabbits were acclimatised to the test conditions for a period of 6 days (Animal No. 1) and 9 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 cards were labelled with study no., study type, test system, sex, dose, animal number, experimental start and completion date. Husbandry ConditionsDiet:All animals were provided conventional laboratory rabbit dietWater :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 ConditionTemperature: Minimum: 19.30 °C Maximum: 21.60 °CRelative humidity: Minimum: 49.90% Maximum: 66.20`%Light-dark-rhythm: 12 hour light and 12 hour darkAir Changes: More than 12 changes per hour
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
Preparation of Application SiteApproximately 24 h prior to treatment, the fur coat of each rabbit was removed from dorsal lumbar region approximately 6 X 6 cm at contralateral sites on each rabbit using clipper, one as control and other site as treatment. Rabbits with healthy intact skin were selected for the study.Test Item Application ProcedureA dose of 0.5 ml test item as such was applied uniformly over clipped area (approximately 6 X 6 cm) of the trunk of each rabbit skin (treated site) and 0.5 ml distilled water was applied at control site. Test item was held in contact with the skin with a porous gauze dressing and non-irritating tape (Micropore 3”) throughout a 4-hour exposure period, to prevent access by the rabbits to the patch and resultant ingestion of the test item. At the end of the exposure period, residual test item was removed by using cotton soaked in distilled water.
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
A dose of 0.5 ml test item as such was applied uniformly over clipped area (approximately 6 X 6 cm) of the trunk of each rabbit skin (treated site) and 0.5 ml distilled water was applied at control site.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: animal 1
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: animal 2
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: animal 3
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: animal 1
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: animal 2
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: animal 3
Irritant / corrosive response data:
The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 3.00, 3.00, 3.00 and 2.00, 2.00, 2.00 for erythema and oedema formation, respectively.

Table 1

Skin Reaction

 

In Treated area Dose:0.5 ml                                                                                            Sex:Male

 

Animal

No.

Test

Treated

 area

Erythema score

Oedema score

1h

24h

48h

72h

Day 7

Day 14

1h

24h

48h

72h

Day 7

Day 14

1

Initial

Left

2

3

3

3

2

0

1

2

2

2

2

0

2

Confirmatory

Right

2

3

3

3

2

0

1

2

2

2

2

0

3

Right

2

3

3

3

2

0

1

2

2

2

2

0

 

 

 

 

In Control areaDose:0.5 ml of distilled water                                                   Sex:Male

 

Animal

No.

Test

Treated

 area

Erythema score

Oedema score

1h

24h

48h

72h

Day 7

Day 14

1h

24h

48h

72h

Day 7

Day 14

1

Initial

Right

0

0

0

0

0

0

0

0

0

0

0

0

2

Confirmatory

Left

0

0

0

0

0

0

0

0

0

0

0

0

3

Left

0

0

0

0

0

0

0

0

0

0

0

0

 

Key: h = Hour.

Erythema                                                                               Oedema

0 =No erythema                                                                   0 =No oedema

2 = Well defined erythema                                                                            1 =Very slight oedema (barely perceptible)

3 =Moderate to severe erythema                                                    2 =Slight oedema (edges of area well defined by definite raising)
Table 1 Continued…

Mean Individual Animal Score at 24, 48 and 72 hours (Treated Site)

 

                     Animal Number                  

Observations                      

1

2

3

Erythema

3.00

3.00

3.00

Oedema

2.00

2.00

2.00

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Erythema and oedema (skin irritation) were found at the end of 72 hour observation period after patch removal.Hence, it was concluded that Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene  (CAS No. – 37330-39-5) was “Skin-Irritating” to the Male New Zealand White rabbits under the experimental conditions tested and Classified as “Category 2” as per CLP regulation.
Executive summary:

Acute Dermal Irritation/corrosion of Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene  was studied (CAS No. – 37330-39-5)in Rabbits. Three healthy young adult Male rabbits were used for conducting acute dermal irritation/corrosion study.

The individual mean score at24, 48 and 72 hoursfor animal nos. 1, 2 and 3 were 3.00, 3.00, 3.00 and 2.00, 2.00, 2.00 for erythema and oedema formation, respectively.  

Hence, it was concluded that Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene  (CAS No. – 37330-39-5) was “Skin-Irritating” to the Male New Zealand White rabbits under the experimental conditions tested and Classified as “Category 2” as per CLP regulation.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation-

Acute Dermal Irritation/corrosion ofReaction mass of Cardanol diene and Cardanol monoene and Cardanol triene was studied (CAS No. – 37330-39-5)in Rabbits.Three healthy young adult Male rabbits were used for conducting acute dermal irritation/corrosion study.

The individual mean score at24, 48 and 72 hoursfor animal nos. 1, 2 and 3 were 3.00, 3.00, 3.00 and 2.00, 2.00, 2.00 for erythema and oedema formation, respectively.  

Hence, it was concluded that Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene  (CAS No. – 37330-39-5) was “Skin-Irritating” to the Male New Zealand White rabbits under the experimental conditions tested and Classified as “Category 2” as per CLP regulation.

Eye Irritation

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)isAn Eye IrritantIrritating to Eyes”ofNew Zealand White Male rabbit eyes.


Justification for selection of skin irritation / corrosion endpoint:
Erythema and oedema (skin irritation) were found at the end of 72 hour observation period after patch removal.
Hence, it was concluded that Cardanol (CAS No. – 37330-39-5) was “Skin-Irritating” to the Male New Zealand White rabbits under the experimental conditions tested and Classified as “Category 2” as per CLP regulation.

Justification for selection of eye irritation endpoint:
Data is experimental data from a GLP laboratory and hence consiered to be "reliable without restriction"

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Experimental results indicate that Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene  (CAS No 37330 -39 -5) causes skin and eye irritation and hence is classified as a skin and eye irritant category 2