5-((4-chloro-6-((8-hydroxy-3,6-disulfo-7-((2-sulfo-4-((2(sulfooxy)ethyl)sulfonyl)phenyl)diazenyl)naphthalen-1-yl)amino)-1,3,5-triazin-2-yl)amino)-4-hydroxy-3-((Z)-(3-sulfophenyl)diazenyl)naphthalene-2,7-disulfonic acid

Endpoint summary

Description of key information

Skin Irritation:

The test chemical was assessed for primary irritation to the skin of rabbits according to the Ecological and Toxicological Association of Dyestuffs Manufacturers (ETAD) test based upon the method described in the 'Code of Federal Regulations', Title 15, Section 1500.41.

Under the test conditions employed, the test chemical produced a Primary Irritation Index within the range 0.0 - 0.5 and was thus classified 'non-irritant' to skin.

Eye irritation:

Single ocular instillation of test chemical, without rinse, into the conjunctival sac resulted in immediate pain reactions varying from practically no initial pain i.e. a few blinks only in one animal, to moderate initial pain in two animals with rubbing of eyes with paws. Three rabbits presented an intermediate response with reflex closure of the eyes without rubbing. Subsequent eye irritation consisted of occasional minor redness and chemosis of the conjunctiva up to 24 hours after treatment in five rabbits. The sixth animal showed greater irritation, with initial discharge at one hour, grade 2 chemosis up to 48 hours, persistent grade 1 conjunctival redness to Day 7 and corneal opacity for four days, never exceeding one-half the total area and clearing by Day 7. These responses resulted in an Irritation Score of 2.6. Hence, based on the observations and scores, it was considered to be not irritating to rabbit eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Weight of evidence approach based on the available data of the read-across chemicals.

Justification for type of information:

Weight of evidence approach based on the available data of the read-across chemicals.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

WoE report is based on skin irritation study for read across chemicals.

GLP compliance:

not specified

Species:

other: 2. Rabbit 3. Rat

Strain:

other: 2. New Zealand White 3.Sprague-Dawley

Details on test animals or test system and environmental conditions:

2. TEST ANIMALS
- Sex: male
- Weight at study initiation: 2.5 - 3.5 kg bodyweight
- Housing:were housed individually in suspended galvanized and stainless steel cages (from Cope
and Cope Ltd.), measuring 0.6 x 0.6 x 0.4 m high and fitted with mesh floors and automatic watering
- Diet (e.g. ad libitum): complete pelleted rabbit diet; Diet RAG modified, from Labsure Animal Foods,
Poole, Dorset; ad libitum
- Water (e.g. ad libitum): water; ad libitum
- Acclimation period:All rabbits were held for a minimum period of seven days before entering the
study.
- Identification: Each animal was weighed and allocated by random selection to the appropriate test
group, in which it was identified by numbered ear-tag.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature was controlled within the range 15 0 ± 2 0 C
- Photoperiod (hrs dark / hrs light):lighting was restricted to 14 hours in each period of 24 hours

3. - Source: National Institute of Biosciences, Pune.
- Females (if applicable) nulliparous and non-pregnant: No data available
- Age at study initiation: Young adult male and female rats aged between 6 – 9 weeks were used.
- Weight at study initiation: The weight ranges of approximately 239.1 to 272.5 grams at initiation of
dosing were used.
Body weights at the start :
Male
Mean : 269.94 g (= 100 %)
Minimum : 266.4 g (- 1.31 %)
Maximum : 272.5 g (+ 0.95 %)
Total No. of animals : 5
Female
Mean : 244.56 g (= 100 %)
Minimum : 239.1 g (- 2.23 %)
Maximum : 250.4 g (+ 2.39 %)
Total No. of animals : 5
- Fasting period before study: No data
- Housing: The rats were individually housed in polycarbonate cages with paddy husk as bedding.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad
libitum from individual feeders.
- Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages.
All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 to 22.3 degree centigrade.
- Humidity (%): 55.7% to 59.6%.
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to
the room.
IN-LIFE DATES: 30-09-2016 to 15-10-2016

Type of coverage:

other: 2. occlusive 3. semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

2. 0.5 g moistened with water
3. TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): No
VEHICLE
- Amount(s) applied (volume or weight with unit):No data
- Concentration (if solution): No data
- Lot/batch no. (if required): No data
- Purity: No data
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): No data
- Concentration (if solution): No data
POSITIVE CONTROL
- Amount(s) applied (volume or weight): No data
- Concentration (if solution): No data

Duration of treatment / exposure:

2. 24 hours
3. 24 hours

Observation period:

2. 24,48 and 72 hours
3. 14 days

Number of animals:

2. 6
3. 10 (5/sex)

Details on study design:

2. TEST SITE
- Area of exposure: back
- % coverage: a square patch of surgical gauze measuring 2.5 cm x 2.5 cm
- Type of wrap if used: The entire trunk of the animal is then wrapped with an impervious material
such as rubber or PVC (after ensuring that the test substance does not react chemically with the
rubber or PVC)
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 24, 48 and 72 hours
SCORING SYSTEM:
- Method of calculation: Draize method
3. TEST SITE
- Area of exposure: Trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: Approximately 10% of the total body surface area.
- Type of wrap if used: Porous gauze dressing and non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water was used to remove residual test item.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : Dermal reaction was observed daily for study period of 14 days.
SCORING SYSTEM: Draize Method.
OTHER OBSERVATIONS
Type and Frequency of Tests, Analyses and Measurements
Viability: Twice daily.
Clinical Observations and General Appearance:
Animals were observed for clinical signs, mortality, until sacrifice.
Onset, duration and severity of any sign were recorded. The clinical signs and mortality observati
ons were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily ther
eafter for 14 day. Daily observation was done as far as possible at the same time.
The observations were included general clinical signs, observations of eyes, mucous membranes, re
spiratory, circulatory system and behavior pattern.
Body weights:
Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7
and at termination on day 14.
Gross Pathology:
Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all
the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the
study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).
Histopathology:
No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was
performed.

Irritation parameter:

overall irritation score

Remarks:

2

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Max. score:

8

Reversibility:

not specified

Irritation parameter:

overall irritation score

Remarks:

2

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

8

Reversibility:

not specified

Irritation parameter:

erythema score

Remarks:

3.

Basis:

mean

Time point:

14 d

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Remarks:

3.

Basis:

mean

Time point:

14 d

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

2. No responses were detected and a Primary Irritation Index of zero was obtained
3. Overall result:
Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during
the study period of 14 days.
Sex : Female
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during
the study period of 14 days.

Other effects:

3. Clinical Signs of Mortality
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 9.69% a
nd 16.50% respectively.
Sex : Female
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 5.02% a
nd 9.12% respectively.
Gross Pathological Findings
Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose
group.

Interpretation of results:

other: Not irritating

Conclusions:

The test chemical was assessed for primary irritation to the skin of rabbits according to the Ecological and Toxicological Association of Dyestuffs Manufacturers (ETAD) test based upon the method described in the 'Code of Federal Regulations', Title 15, Section 1500.41. Under the test conditions employed, the test chemical produced a Primary Irritation Index within the range 0.0 - 0.5 and was thus classified 'non-irritant' to skin.

Executive summary:

A study was conducted according to the method described in the 'Code of Federal Regulations', Title 15, Section 1500.41 to predict the potential for inflammatory or corrosive activity in single, occluded, primary contact of the test chemical with the skin of the rabbit. 6 albino male New Zealand White rabbits were used for the study. The rabbits were fed standard pelleted rabbit diet and water, ad libitum and housed in metal cages throughout the study. Before intended application, both sides of the back were clipped as close to the skin as possible using electric clippers (chemical depilatories were not used). Two to three hours later, abrasions were made to the upper third of one side of the back (flank area behind the ribs). The abrasions were made by using the back of the point of a scalpel blade to scratch a 5 x 5 lattice in an area measuring 2.5cm2 , such that only the stratum corneum was penetrated and bleeding did not occur. 0.5 g of powder were prepared as a paste by addition of a minimal volume of water.One application is made to the skin area previously abraded and one application is made to the intact skin in the corresponding position on the other side of the back. The entire trunk of the animal is then wrapped with an impervious material such as rubber or PVC (after ensuring that the test substance does not react chemically with the rubber or PVC) for the 24-hour period of exposure. The animal was not immobilised but the patches are held in place using bandages or elasticated stockingette. After the 24-hour exposure, the patches are removed and the reactions evaluated without washing the application site The dermal reactions were observed and scored at 24,48 and 72 hours according to the method of Draize. No responses were detected and a Primary Irritation Index of zero was obtained.It was thus classified under the category "Not Classified".

Another study was designed and conducted to determine the dermal reaction profile of test chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. Ten rats (5 male and 5 female) were used for conducting dermal irritation /corrosion study. The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected. Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was moistened with distilled water. The test item was applied onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.  The overall irritation score of the substance was determined to be 0 and no erythema and edema (skin irritation) were found at the end of 14 days observation period after patch removal. Hence, it was concluded that the test chemical was Non-Irritating to the skin of Sprague Dawley rats under the experimental conditions tested and classified as “Category- 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:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Weight of evidence approach based on the available data of the read-across chemicals.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

WoE report is based on eye irritation study for read across chemicals.

GLP compliance:

not specified

Species:

rabbit

Strain:

other: 2. New Zealand White 3. Not specified

Details on test animals or tissues and environmental conditions:

2. TEST ANIMALS
- Sex: male
- Weight at study initiation: 2.5 - 3.5 kg bodyweight
- Housing:were housed individually in suspended galvanized and stainless steel cages (from Cope
and Cope Ltd.), measuring 0.6 x 0.6 x 0.4 m high and fitted with mesh floors and automatic watering
- Diet (e.g. ad libitum): complete pelleted rabbit diet; Diet RAG modified, from Labsure Animal Foods,
Poole, Dorset; ad libitum
- Water (e.g. ad libitum): water; ad libitum
- Acclimation period:All rabbits were held for a minimum period of seven days before entering the
study.
- Identification: Each animal was weighed and allocated by random selection to the appropriate test
group, in which it was identified by numbered ear-tag.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature was controlled within the range 15 0 ± 2 0 C
- Photoperiod (hrs dark / hrs light):lighting was restricted to 14 hours in each period of 24 hours
3. No data available

Vehicle:

other: 2. unchanged (no vehicle) 3.Not specified

Controls:

yes, concurrent no treatment

not specified

Amount / concentration applied:

2. 100mg
3. 0.1 ml of 1.0% aqueous solution

Duration of treatment / exposure:

2. single exposure
3. No data available

Observation period (in vivo):

2. The eyes were examined and the grades of ocular reaction were graded at 1 hour, 24 hours, 48 hours
and 72 hours after instillation
3. No data available

Duration of post- treatment incubation (in vitro):

2. no data available
3. No data available

Number of animals or in vitro replicates:

2. 6 male rabbits
3. No data available

Details on study design:

2. REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
- Time after start of exposure: The treated eyes were not washed after instillation of the test chemical
SCORING SYSTEM: Draize method for scoring of ocular lesions
3. No data available

Irritation parameter:

overall irritation score

Remarks:

2.

Basis:

mean

Time point:

72 h

Score:

2.6

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Not specified

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

2. Single ocular instillation of test chemical, without rinse, into the conjunctival sac resulted in immediate pain reactions varying from practically no initial pain i.e. a few blinks only in one animal, to moderate initial pain in two animals with rubbing of eyes with paws. Three rabbits presented an intermediate response with reflex closure of the eyes without rubbing. Subsequent eye irritation consisted of occasional minor redness and chemosis of the conjunctiva up to 24 hours after treatment in five rabbits. The sixth animal showed greater irritation, with initial discharge at one hour, grade 2 chemosis up to 48 hours, persistent grade 1 conjunctival redness to Day 7 and corneal opacity for four days, never exceeding one-half the total area and clearing by Day 7. These responses resulted in an Irritation
Score of 2.6.

Interpretation of results:

other: Not Irritating

Conclusions:

Single ocular instillation of test chemical, without rinse, into the conjunctival sac resulted in immediate pain reactions varying from practically no initial pain i.e. a few blinks only in one animal, to moderate initial pain in two animals with rubbing of eyes with paws. Three rabbits presented an intermediate response with reflex closure of the eyes without rubbing. Subsequent eye irritation consisted of occasional minor redness and chemosis of the conjunctiva up to 24 hours after treatment in five rabbits.The sixth animal showed greater irritation, with initial discharge at one hour, grade 2 chemosis up to 48 hours, persistent grade 1 conjunctival redness to Day 7 and corneal opacity for four days, never exceeding one-half the total area and clearing by Day 7. These responses resulted in an Irritation
Score of 2.6. Hence, based on the observations and scores, it was considered to be not irritating to rabbit eyes.

Executive summary:

A study was performed according to method described in the 'Code of Federal Regulations', Title 16, Section 1500.42 to predict the potential for damage to the conjunctiva, cornea and iris in a single exposure of the given test chemical for indeterminate duration in the rabbit. 100 mg of the undiluted test chemical was instilled into the left eye of 6 male New Zealand White rabbits. The untreated eyes served as controls.The treated eyes remained unwashed throughout the study. The eyes were examined and the grades of ocular reaction were graded at 1 hour, 24 hours, 48 hours and 72 hours after instillation.The eyes were also evaluated for Pain upon instillation of the test chemical. The ocular reactions were graded according to the method of Draize. For each animal, the scores for the cornea, iris and conjunctiva were added for each of the 24, 48 and 72 hour time periods to give a total score/animal/time period. Then the total scores so obtained were added together and divided by 18.The resultant value was the Irritation Score. Single ocular instillation of test chemical, without rinse, into the conjunctival sac resulted in immediate pain reactions varying from practically no initial pain i.e. a few blinks only in one animal, to moderate initial pain in two animals with rubbing of eyes with paws. Three rabbits presented an intermediate response with reflex closure of the eyes without rubbing. Subsequent eye irritation consisted of occasional minor redness and chemosis of the conjunctiva up to 24 hours after treatment in five rabbits. The sixth animal showed greater irritation, with initial discharge at one hour, grade 2 chemosis up to 48 hours, persistent grade 1 conjunctival redness to Day 7 and corneal opacity for four days, never exceeding one-half the total area and clearing by Day 7. These responses resulted in an Irritation Score of 2.6. Hence, based on the observations and scores, it  was considered to be not irritating to rabbit eyes.

Test chemical was used as test material to evaluate eye irritation potential on rabbit.The test chemical was subjected to rabbit eye in the concentration 0.1 ml1.0% aqueous solution .No ocular reaction was observed .Hence , the test chemical was considered to be not eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin Irritation:

A study was conducted according to the method described in the 'Code of Federal Regulations', Title 15, Section 1500.41 to predict the potential for inflammatory or corrosive activity in single, occluded, primary contact of the test chemical with the skin of the rabbit. 6 albino male New Zealand White rabbits were used for the study. The rabbits were fed standard pelleted rabbit diet and water, ad libitum and housed in metal cages throughout the study. Before intended application, both sides of the back were clipped as close to the skin as possible using electric clippers (chemical depilatories were not used). Two to three hours later, abrasions were made to the upper third of one side of the back (flank area behind the ribs). The abrasions were made by using the back of the point of a scalpel blade to scratch a 5 x 5 lattice in an area measuring 2.5cm2 , such that only the stratum corneum was penetrated and bleeding did not occur. 0.5 g of powder were prepared as a paste by addition of a minimal volume of water.One application is made to the skin area previously abraded and one application is made to the intact skin in the corresponding position on the other side of the back. The entire trunk of the animal is then wrapped with an impervious material such as rubber or PVC (after ensuring that the test substance does not react chemically with the rubber or PVC) for the 24-hour period of exposure. The animal was not immobilised but the patches are held in place using bandages or elasticated stockingette. After the 24-hour exposure, the patches are removed and the reactions evaluated without washing the application site The dermal reactions were observed and scored at 24,48 and 72 hours according to the method of Draize. No responses were detected and a Primary Irritation Index of zero was obtained.It was thus classified under the category "Not Classified".

Another study was designed and conducted to determine the dermal reaction profile of test chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. Ten rats (5 male and 5 female) were used for conducting dermal irritation /corrosion study. The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected. Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was moistened with distilled water. The test item was applied onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.  The overall irritation score of the substance was determined to be 0 and no erythema and edema (skin irritation) were found at the end of 14 days observation period after patch removal. Hence, it was concluded that the test chemical was Non-Irritating to the skin of Sprague Dawley rats under the experimental conditions tested and classified as “Category- Not Classified” as per CLP Classification.

Eye Irritation:

A study was performed according to method described in the 'Code of Federal Regulations', Title 16, Section 1500.42 to predict the potential for damage to the conjunctiva, cornea and iris in a single exposure of the given test chemical for indeterminate duration in the rabbit. 100 mg of the undiluted test chemical was instilled into the left eye of 6 male New Zealand White rabbits. The untreated eyes served as controls.The treated eyes remained unwashed throughout the study. The eyes were examined and the grades of ocular reaction were graded at 1 hour, 24 hours, 48 hours and 72 hours after instillation.The eyes were also evaluated for Pain upon instillation of the test chemical. The ocular reactions were graded according to the method of Draize. For each animal, the scores for the cornea, iris and conjunctiva were added for each of the 24, 48 and 72 hour time periods to give a total score/animal/time period. Then the total scores so obtained were added together and divided by 18.The resultant value was the Irritation Score. Single ocular instillation of test chemical, without rinse, into the conjunctival sac resulted in immediate pain reactions varying from practically no initial pain i.e. a few blinks only in one animal, to moderate initial pain in two animals with rubbing of eyes with paws. Three rabbits presented an intermediate response with reflex closure of the eyes without rubbing. Subsequent eye irritation consisted of occasional minor redness and chemosis of the conjunctiva up to 24 hours after treatment in five rabbits. The sixth animal showed greater irritation, with initial discharge at one hour, grade 2 chemosis up to 48 hours, persistent grade 1 conjunctival redness to Day 7 and corneal opacity for four days, never exceeding one-half the total area and clearing by Day 7. These responses resulted in an Irritation Score of 2.6. Hence, based on the observations and scores, it  was considered to be not irritating to rabbit eyes.

in another study, Test chemical was used as test material to evaluate eye irritation potential on rabbit.The test chemical was subjected to rabbit eye in the concentration 0.1 ml1.0% aqueous solution .No ocular reaction was observed .Hence , the test chemical was considered to be not eye irritant.

Justification for classification or non-classification

Based on the available in-vivo data for the test chemical, it can be concluded that the test chemical was considered to be not irritating to skin and eyes. Thus it can be considered as “Not classified” for skin and eye irritation.