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Diss Factsheets

Administrative data

Description of key information

Skin Irritation:

Acute Dermal Irritation/corrosion Study of test chemical in Rabbits, was performed as per OECD guideline No. 404. A volume of 0.5 ml of test item (as such) was applied to the skin for 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours and on day 7 post patch removal, evaluated and graded as per draize method. The individual mean score at24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively.  Hence, it was concluded that the test chemical is Mild Skin Irritant to the skin of Male New Zealand White rabbits under the experimental conditions tested. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2”.

 

Eye Irritation:

Acute Eye Irritation/Corrosion Study of Test chemical in Rabbits, was performed as per OECD guideline No. 405. The. 0.1 ml of test item was instilled in the other (treated) eye of each rabbit. The eye was observed at 1, 24, 48 and 72 hours after test item instillation. Ophthalmoscope was used for scoring of eye lesions. 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, 0.00, 0.00; 0.00, 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, 0.00, respectively. Hence under the experimental test conditions, the test chemical can be considered as “Non Irritant” to New Zealand White female rabbit eyes. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

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 objective of the study was to assess the irritant and/or corrosive effects of test chemical after dermal application on the intact skin in rabbits
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Procured from LIVEON BIOLABS PVT. LTD., Karnataka, 572106, (CPCSEA Reg. No. 1610/RO/bc12/CPCSEA).
- Sex: Male
- Health Status: Healthy young adults rabbits were used for the study.
- Age at study initiation: 4.0 to 4.5 Months (Approximately)
- Weight at study initiation: Minimum: 1.888 kg and Maximum: 2.612
- 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, Pune) 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: 19.90 °C and Maximum: 22.50 °C
- Humidity (%): Minimum: 51.50 % and Maximum: 67.40 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
VEHICLE: Not applicable
Duration of treatment / exposure:
4-hour exposure period
Observation period:
7 days
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.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: #2 and #3
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: at 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: at 24, 48 and 72 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: at 24, 48 and 72 hours
Score:
1.67
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours and on day 7 post patch removal, evaluated and graded as per draize method.
The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively.
Other effects:
Clinical Observation
No systemic toxicity was observed at treated rabbits during the experimental period.
Mortality
No mortality was observed during the observation period.
Body weight
Body weights were increased as compared to day 0 in all the three animals

Table 1: Skin Reaction

In Treated area Dose:0.5 ml of test item                                                                          Sex:Male

Animal

No.

Test

Treated

 area*

Erythema score

Oedema score

1h

24h

48h

72h

Day 7

1h

24h

48h

72h

Day 7

1

Initial

Right

0

1

1

1

0

0

1

1

1

0

2

Confirmatory

Left

1

2

2

2

0

1

1

2

1

0

3

Left

1

2

2

2

0

1

1

2

2

0

In Control area  Dose: 0.5 ml of distilled water                Sex:Male

Animal

No.

Test

Treated

 area*

Erythema score

Oedema score

1h

24h

48h

72h

 

Day 7

1h

24h

48h

72h

 

Day 7

1

Initial

Left

0

0

0

0

0

0

0

0

0

0

2

Confirmatory

Right

0

0

0

0

0

0

0

0

0

0

3

Right

0

0

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)                           1 =Very slight oedema (barely perceptible)

2 =Well defined erythema                                                    2 = Slight oedema (edges of area well defined by definite raising)

Mean Individual Animal Score at 24, 48 and 72 hours

                     Animal Number                  

Observations                      

1

2

3

Erythema

1.00

2.00

2.00

Oedema

1.00

1.33

1.67

Table 2: Individual Animal Body Weight

Animal

No.

Body Weight (kg)

Prior to Dosing

At termination

1

1.888

2.048

2

2.184

2.210

3

2.612

2.648

Table 3: Individual AnimalClinical Signs

Animal

No.

Days (Post dosing Observation)

0

1

2

3

4

5

6

7

1

1

1

1

1

1

1

1

1

2

1

1

1

1

1

1

1

1

3

1

1

1

1

1

1

1

1

Key:1 = Normal

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively.
Hence, it was concluded that the test chemical was Mild Skin Irritant to the skin of Male New Zealand White rabbits under the experimental conditions tested.
Executive summary:

Acute Dermal Irritation/corrosion Study of test chemical in Rabbits was performed as per the OECD guideline No. 404.Three healthy young adult male rabbits were used for conducting acute dermal irritation study. The hair of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment. A volume 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 and0.5 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 cotton soaked in distilled 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.

At 1 hour observation animal no. 1 revealed no erythema and no oedema. At 24 hour observation very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed. After 24 hours no severe skin lesions were observed hence a confirmatory test was conducted on additional two rabbits (No. 2 and 3) to confirm the irritant nature of the test item. At 48 and 72 hour observation, very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed. Animal no.1 was recovered to normal on day 7.Animal no. 2 and 3 revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible)at 1 hour observation. At 24 hour observation animal no. 2 and 3 revealed well defined erythema and very slight oedema (barely perceptible).At 48 hour observation animal no. 2 and 3 revealed well defined erythema and slight oedema (edges of area well defined by definite raising). At 72 hour observation, animal no. 2 revealed well defined erythema and very slight oedema (barely perceptible) and animal no. 3revealedwell defined erythema and slight oedema (edges of area well defined by definite raising). Animal no.2 and 3recovered to normal on day 7. The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours and on day 7 post patch removal, evaluated and graded as per draize method.

The individual mean score at24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively.  Hence, it was concluded that the test chemical is Mild Skin Irritant to the skin of Male New Zealand White rabbits under the experimental conditions tested.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
D
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:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Procured from Sainath Agencies, Hyderabad
- Age at study initiation: 2.5 to 3.5 Months (Approximately)
- Weight at study initiation: Minimum: 1.596 kg and Maximum: 1.748 kg
- Housing: 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 (Nutrivet Life Sciences, Pune) ad libitum. Batch No.: 200005.
- 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 card was labelled with at least study no., study type, test system, sex, dose, experiment start date and experiment completion date

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.60 °C and Maximum: 22.20 °C
- Humidity (%): Minimum: 56.50 % and Maximum: 69.20%
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12
Vehicle:
unchanged (no vehicle)
Controls:
yes
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):
72 hrs
Number of animals or in vitro replicates:
3 females
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 hrs

SCORING SYSTEM: Grading of irritation lesions was carried out as per Draize Method

TOOL USED TO ASSESS SCORE: ophthalmoscope
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 and #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2 and #3
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal: #1, #2 and #3
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
The following were observed in treated rabbits.
In the initial test, 0.1 ml of test item 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 ml of test item 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 was normal throughout the experimental period of 72 hour.
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 in all the animals; Iris: Normal in all the animals. Conjunctivae - Some blood vessels definitely hyperaemic (injected) was observed in all the animals; Chemosis: No swelling (normal) was seen in all the animals.
Observation at 24, 48 and 72 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 - Blood vessels normal in all the animals; Chemosis: No swelling (normal) 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 0% damage in animal no. 1, 2 and 3.
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
All the rabbits increased body weight at 72 hours (termination) as compared to day 0 (Refer Table 3).

Table 1 : Individual Animal Eye Irritation Scores

 

In Treated area Dose: 0.1 ml of test item (as such)                                               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

1

0

0

0

0

1

0

0

0

0

1

0

0

0

Chemosis

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Corneal Damage%

0%

0%

0%

Dose: Untreated (Control Eye)                                                                       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%

Key:*= Pre-exposure eye examination

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

0.00

0.00

0.00

Chemosis

0.00

0.00

0.00

Formula :

 

Mean Eye Irritation Score =

                          

Sum of the Individual Animal Score for eye reaction at 24, 48 and 72 hours

Number of the Observations (3)

Table 2: Individual Animal Clinical Signs

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

Animal No.

Animal Body Weight (kg)

Prior to application

At termination

1

1.620

1.712

2

1.748

1.820

3

1.596

1.658

Key: kg = Kilogram

Interpretation of results:
other: not irritating
Conclusions:
Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of New Zealand White female rabbits was observed at 72 hours.
Hence, the test chemical can be considered as not irritating to the eyes of New Zealand White female rabbits.
Executive summary:

Acute Eye Irritation/Corrosion Study of test chemical in Rabbits was performed as per OECD guideline no. 405. 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 and 72 hours after test item instillation. Ophthalmoscope was used for scoring of eye lesions.

In the initial test, 0.1 ml of test item 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 till 24 hour observation hence a confirmatory test was conducted on additional two rabbits (animal no. 2 and 3); 0.1 ml of test item was instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control. Ocular lesions were seen in animal no. 2 and 3 which were recovered till 72 hours observation. Untreated eye of all the three rabbits was normal throughout the experimental period of 72 hours. At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 0% damage in animal no. 1, 2 and 3.

 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, 0.00, 0.00; 0.00, 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, 0.00, respectively. Hence under the experimental test conditions, the test chemical can be considered as “Non Irritant” to New Zealand White female rabbit eyes.

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 the OECD guideline No. 404.Three healthy young adult male rabbits were used for conducting acute dermal irritation study. The hair of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment. A volume 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 and0.5 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 cotton soaked in distilled 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.

At 1 hour observation animal no. 1 revealed no erythema and no oedema. At 24 hour observation very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed. After 24 hours no severe skin lesions were observed hence a confirmatory test was conducted on additional two rabbits (No. 2 and 3) to confirm the irritant nature of the test item. At 48 and 72 hour observation, very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed. Animal no.1 was recovered to normal on day 7.Animal no. 2 and 3 revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible)at 1 hour observation. At 24 hour observation animal no. 2 and 3 revealed well defined erythema and very slight oedema (barely perceptible).At 48 hour observation animal no. 2 and 3 revealed well defined erythema and slight oedema (edges of area well defined by definite raising). At 72 hour observation, animal no. 2 revealed well defined erythema and very slight oedema (barely perceptible) and animal no. 3revealedwell defined erythema and slight oedema (edges of area well defined by definite raising). Animal no.2 and 3recovered to normal on day 7. The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours and on day 7 post patch removal, evaluated and graded as per draize method.

The individual mean score at24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively.  Hence, it was concluded that the test chemical is Mild Skin Irritant to the skin of Male New Zealand White rabbits under the experimental conditions tested.

 

 Eye irritation

Acute Eye Irritation/Corrosion Study of test chemical in Rabbits was performed as per OECD guideline no. 405. 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 and 72 hours after test item instillation. Ophthalmoscope was used for scoring of eye lesions.

In the initial test, 0.1 ml of test item 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 till 24 hour observation hence a confirmatory test was conducted on additional two rabbits (animal no. 2 and 3); 0.1 ml of test item was instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control. Ocular lesions were seen in animal no. 2 and 3 which were recovered till 72 hours observation. Untreated eye of all the three rabbits was normal throughout the experimental period of 72 hours. At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 0% damage in animal no. 1, 2 and 3.

 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, 0.00, 0.00; 0.00, 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, 0.00, respectively. Hence under the experimental test conditions, the test chemical can be considered as “Non Irritant” to New Zealand White female rabbit eyes.

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 chemical is able to cause mild skin irritation but unlikely to cause eye damage. Hence the test chemical can be classified under the category “Category 2” for skin and “Not Classified” for eye as per CLP.