Potassium iodide

Endpoint summary

Description of key information

Skin Irritation:

Acute Dermal Irritation/corrosion Study of test chemical in Rabbits, was performed as per OECD guideline No. 404 on three healthy young adult female New Zealand White rabbits. The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.33, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively. No erythema and no edema (skin irritation) were observed at 72 hours observation period after patch removal. Hence, it was concluded that the test substance was Non-Irritating to the skin of female New Zealand White rabbits under the experimental conditions tested and being classified as “Not Classified” as per CLP Classification.

 

Eye Irritation:

Acute eye irritation/corrosion study of test chemical in Rabbits, was performed as per OECD guideline No. 405 on three healthy young adult female New Zealand White rabbits. The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours (at treated site) for corneal opacity, iris, conjunctiva and chemosis were observed to be 0.00, 0.00, 1.00, 0.33; 0.00, 0.00, 0.67, 0.00 and 0.00, 0.00, 1.00, 0.00 respectively. Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed within 72 hours.  Hence, it was concluded that the test substance was Non-Irritating to the eyes of female New Zealand White rabbits under the experimental conditions tested and being classified as “Not Classified” as per CLP Classification.

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)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from experimental study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The skin irritation study of test chemical was condcuted to determine the skin irritation potential of test chemical according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion).

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Species:Rabbit (Oryctolagus cuniculus)
-Strain:New Zealand White
- Sex: Female
- Health Status: Healthy young adults rabbits were used for the study.Females were nulliparous and non-pregnant
- Age at study initiation: 4.5 to 5.0 Months (Approximately)
- Weight at study initiation: Minimum: 1.860 kg & Maximum: 2.458 kg (Prior to Treatment)
- Housing: The animals were housed individually in stainless steel cages
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences) ad libitum. Batch No. 200004
- 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 6 days (Animal No.-1) and 8 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 at least study no., study type, test system, sex, dose, experiment start date and experiment completion date.
- 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

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 20.30°C and Maximum: 22.70 °C
- Humidity (%): Minimum: 48.30 % and Maximum: 68.30 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
VEHICLE: Not applicable

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hrs

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approximately 6 X 6 cm at contralateral sites
- Type of wrap if used: porous gauze dressing and non-irritating tape (Micropore 3”)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using cotton soaked in distilled water
- Time after start of exposure: 4hr

Control site: 0.5 ml distilled water was applied at control site.

SCORING SYSTEM: Draize Method

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No erythema and edema (skin irritation) were observed at the end of 72 hour observation period after patch removal.

Other effects:

no effects observed

Table 1

Skin Reaction

 

In Treated area Dose:0.5 g (Pulverized form)                                                     Sex:Female

 

Animal No.	Test	Treated  area	Erythema score				Oedema score
			1h	24h	48h	72h	1h	24h	48h	72h
1	Initial	Right	1	1	0	0	0	0	0	0
2	Confirmatory	Left	0	0	0	0	0	0	0	0
3		Left	1	0	0	0	0	0	0	0

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

 

Animal No.	Test	Treated area	Erythema score				Oedema score
			1h	24h	48h	72h	1h	24h	48h	72h
1	Initial	Left	0	0	0	0	0	0	0	0
2	Confirmatory	Right	0	0	0	0	0	0	0	0
3		Right	0	0	0	0	0	0	0	0

Key: h = Hour.

Erythema                                                                                                       Oedema

0 =No erythema                                                                                           0 =No oedema

1 = Very slight erythema(barely perceptible)

Table 1 Continued…

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

 

Animal Number                   Observations	1	2	3
Erythema	0.33	0.00	0.00
Oedema	0.00	0.00	0.00

 

Interpretation of results:

other: not irritating

Conclusions:

The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.33, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively. No erythema and no edema (skin irritation) were observed at 72 hours observation period after patch removal.
Hence, it was concluded that the test substance was Non-Irritating to the skin of female New Zealand White rabbits under the experimental conditions tested and being classified as “Not Classified” as per CLP Classification.

Executive summary:

Acute Dermal Irritation/corrosion Study of test chemical in Rabbits, was performed as per OECD guideline No. 404.  Three healthy young adult female New Zealand White rabbits were used for conducting acute dermal irritation/corrosion study. Body weights were recorded on day 0 (prior to application) and at termination. Rabbits with good intact skin were selected for the study. The hairs of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment. A dose of 0.5 ml of test item (as such) was applied to the skin, over an area of approximately 6 x 6 cm clipped of hair on one side of rabbits. The other untreated side was kept as control area and 0.5 ml of distilled water was applied at this site. At the end of 4 hours, the gauze patch was removed and test item application site was wiped with water without altering the integrity of the epidermis.

Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch. Very slight erythema (barely perceptible) and no edema was observed at 1 hour of observation. At 24 hour very slight erythema (barely perceptible) and no edema was observed. At 48 and 72 hours observation no erythema and no edema was observed in animal no 1.Hence the confirmatory test was conducted on additional two rabbits (no. 2 and 3) to confirm the non-irritant nature of the test item.

The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, and 48 and 72 hours after patch removal, evaluated and graded as per Draize method. In animal no 3, at 1 hour observation post patch removal, reveled very slight erythema (barely perceptible) and no edema whereas Animal No.2 showed no erythema and edema. At 24, 48 and 72 hours, animal nos. 2 and 3 showed no erythema and no oedema.

The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.33, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.No erythema and no edema (skin irritation) were observed at 72 hours observation period after patch removal.

Hence, it was concluded that the test substance was Non-Irritating to the skin of female New Zealand White rabbits under the experimental conditions tested and being classified as “Not Classified” as per CLP Classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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 reports

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
-Species:Rabbit (Oryctolagus cuniculus)
- Source: Procured from NATIONAL INSTITUTE OF BIOSCIENCES, PUNE, India.
-Strain:New Zealand White
- Sex: female
- Health Status: Healthy young adults rabbits were used for the study.Females were nulliparous and non-pregnant
- Age at study initiation: 9 to 11 weeks (Approximately)
- Weight at study initiation: Minimum: 1.560 kg & Maximum: 1.868 kg (Prior to Treatment)
- Housing: The animals were housed individually in stainless steel cages
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences) ad libitum. Batch No. 200004
- 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 6 days (Animal No.-1) and 8 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 at least study no., study type, test system, sex, dose, experiment start date and experiment completion date.
- 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

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.00°C and Maximum: 20.80 °C
- Humidity (%): Minimum: 45.10 % and Maximum: 65.80 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

Vehicle:

unchanged (no vehicle)

Controls:

other: One eye (left) of each of the experimental animals served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): N/A

VEHICLE: N/A

Duration of treatment / exposure:

24 hr

Observation period (in vivo):

All the animals were observed at 1, 24, 48, 72 hours and on day 7 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: after 1 hour
-SCORING SYSTEM:Draize Method
-TOOL USED TO ASSESS SCORE: Ophthalmoscope and fluorescent strips.

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:

3

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:

3

Reversibility:

not specified

Remarks on result:

other: Untreated (Control Eye)

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Remarks:

Treated group

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

not specified

Remarks on result:

no indication of irritation

Remarks:

Treated group

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Treated group

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Remarks:

Treated group

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Treated group

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Treated group

Irritation parameter:

chemosis score

Basis:

animal: #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

not specified

Remarks on result:

no indication of irritation

Remarks:

Treated group

Irritant / corrosive response data:

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 - 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 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 - 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 whereas no swelling (normal) was observed in animal no. 2 and 3.At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 50%, 30% and 30% damage in animal no. 1,2 and 3 respectively. Corneal damage had reversed at 72 hours observation period in animal no. 1 and 3 whereas at 48 hours in animal no. 2. Observation at 48 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 - Some blood vessels definitely hyperaemic (injected) was observed in animal no. 1 and 3 whereas blood vessels normal in animal no. 2; Chemosis: No swelling (normal) was observed in all the animals.Observation at 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 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 3 at 24, 48, 72 hours (at treated site) for corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 1.00, 0.33; 0.00, 0.00, 0.67, 0.00 and 0.00, 0.00, 1.00, 0.00 respectively.

Other effects:

Clinical Observation
No systemic toxicity was observed in treated rabbits during the experimental period.

Mortality
No mortality was observed during the observation period.

Body weight
All the rabbits were observed with body weight gain on day 7 as compared to day 0.

Table 1 : Individual Animal Eye Irritation Scores

 In Treated area Dose:0.1 g of test item (in pulverized form)                            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 2 2 1 0 0 2 2 0 0 0 2 2 1 0 Chemosis 0 1 1 0 0 0 1 0 0 0 0 1 0 0 0 Corneal Damage% 0 ./. 50 30 0 0 ./. 30 0   0 ./. 30 10 0 In Treated area Dose:Untreated                                                                             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 0 0 0 0 Corneal Damage% 0 ./. 0 0 0 0 ./. 0 0 ./. 0 ./. 0 0 0 Key:*= Pre-exposure eye examination.       ./.= Not Applicable 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 1.00 0.67 1.00 Chemosis 0.33 0.00 0.00     Eye Irritation Scores - Mean Values after 24, 48, 72 Hours (Untreated 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 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 Animal No. Animal Body Weight (kg) Prior to application At termination 1 1.868 1.936 2 1.560 1.628 3 1.748 1.820 Key:kg = Kilogram

 

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours (at treated site) for corneal opacity, iris, conjunctiva and chemosis were observed to be 0.00, 0.00, 1.00, 0.33; 0.00, 0.00, 0.67, 0.00 and 0.00, 0.00, 1.00, 0.00 respectively.
Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed within 72 hours.
Hence, it was concluded that the test substance was Non-Irritating to the eyes of female New Zealand White rabbits under the experimental conditions tested and being classified as “Not Classified” as per CLP 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.

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 was instilled in the other (treated) eye of each rabbit. The eye was observed at 1, 24, 48, 72 hour, day 7, day 14 and day 21 for animal no. 1 and 3 whereas at 1, 24, 48 and 72 hour after test item instillation. Ophthalmoscope was used for scoring of eye lesions

In the initial test, 0.1 g of test item (as such) 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); 0.1g of test item (in pulverized form) was 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 of 72 hours.

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 - 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 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 - 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 whereas no swelling (normal) was observed in animal no. 2 and 3.At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 50%, 30% and 30% damage in animal no. 1,2 and 3 respectively. Corneal damage had reversed at 72 hours observation period in animal no. 1 and 3 whereas at 48 hours in animal no. 2.

Observation at 48 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 - Some blood vessels definitely hyperaemic (injected) was observed in animal no. 1 and 3 whereas blood vessels normal in animal no. 2; Chemosis: No swelling (normal) was observed in all the animals.

Observation at 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 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 3 at 24, 48, 72 hours (at treated site) for corneal opacity, iris, conjunctiva and chemosis were observed to be 0.00, 0.00, 1.00, 0.33; 0.00, 0.00, 0.67, 0.00 and 0.00, 0.00, 1.00, 0.00 respectively.

Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed within 72 hours. 

Hence, it was concluded that the test substance was Non-Irritating to the eyes of female New Zealand White rabbits under the experimental conditions tested and being classified as “Not Classified” as per CLP Classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

Acute Dermal Irritation/corrosion Study of test chemical in Rabbits, was performed as per OECD guideline No. 404.  Three healthy young adult female New Zealand White rabbits were used for conducting acute dermal irritation/corrosion study. Body weights were recorded on day 0 (prior to application) and at termination. Rabbits with good intact skin were selected for the study. The hairs of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment. A dose of 0.5 ml of test item (as such) was applied to the skin, over an area of approximately 6 x 6 cm clipped of hair on one side of rabbits. The other untreated side was kept as control area and 0.5 ml of distilled water was applied at this site. At the end of 4 hours, the gauze patch was removed and test item application site was wiped with water without altering the integrity of the epidermis.

Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch. Very slight erythema (barely perceptible) and no edema was observed at 1 hour of observation. At 24 hour very slight erythema (barely perceptible) and no edema was observed. At 48 and 72 hours observation no erythema and no edema was observed in animal no 1.Hence the confirmatory test was conducted on additional two rabbits (no. 2 and 3) to confirm the non-irritant nature of the test item.

 The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, and 48 and 72 hours after patch removal, evaluated and graded as per Draize method. In animal no 3, at 1 hour observation post patch removal, reveled very slight erythema (barely perceptible) and no edema whereas Animal No.2 showed no erythema and edema. At 24, 48 and 72 hours, animal nos. 2 and 3 showed no erythema and no oedema.

The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.33, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively. No erythema and no edema (skin irritation) were observed at 72 hours observation period after patch removal.

Hence, it was concluded that the test substance was Non-Irritating to the skin of female New Zealand White rabbits under the experimental conditions tested and being classified as “Not Classified” as per CLP Classification.

 

 

Eye irritation

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.

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 was instilled in the other (treated) eye of each rabbit. The eye was observed at 1, 24, 48, 72 hour, day 7, day 14 and day 21 for animal no. 1 and 3 whereas at 1, 24, 48 and 72 hour after test item instillation. Ophthalmoscope was used for scoring of eye lesions.

In the initial test, 0.1 g of test item (as such) 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); 0.1g of test item (in pulverized form) was 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 of 72 hours.

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 - 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 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 - 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 whereas no swelling (normal) was observed in animal no. 2 and 3.At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 50%, 30% and 30% damage in animal no. 1,2 and 3 respectively. Corneal damage had reversed at 72 hours observation period in animal no. 1 and 3 whereas at 48 hours in animal no. 2.

Observation at 48 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 - Some blood vessels definitely hyperaemic (injected) was observed in animal no. 1 and 3 whereas blood vessels normal in animal no. 2; Chemosis: No swelling (normal) was observed in all the animals.

Observation at 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 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 3 at 24, 48, 72 hours (at treated site) for corneal opacity, iris, conjunctiva and chemosis were observed to be 0.00, 0.00, 1.00, 0.33; 0.00, 0.00, 0.67, 0.00 and 0.00, 0.00, 1.00, 0.00 respectively.

Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed within 72 hours. 

Hence, it was concluded that the test substance was Non-Irritating to the eyes of female New Zealand White rabbits under the experimental conditions tested and being classified as “Not Classified” as per CLP Classification.

 

Justification for classification or non-classification

The skin and eye irritation potential of test chemical was observed in experimental studies. The results obtained from these studies indicate that the test chemical is not likely to cause skin and eye irritation. Hence the test chemical can be classified under the category “Not Classified”.