Barium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate

Endpoint summary

Description of key information

Acute oral Toxicity: 

The acute oral toxicity dose (LD50) for barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no.: 17852-98-1) was considered based on data available for the structurally similar read across chemicals. The LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate cannot be classified for acute oral toxicity. 

Acute Inhalation Toxicity:

Barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no.: 17852-98-1) has very low vapour pressure (1.32E-18 mmHg), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver.

 Acute dermal Toxicity: 

The acute dermal toxicity dose (LD50) for barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no.: 17852-98-1) was considered based on data available for the structurally similar read across chemicals. The LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate cannot be classified for acute dermal toxicity. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

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

Remarks:

Experimental data of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar 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 two acute oral toxicity studies as- WoE 2 and WoE 3. Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Specific details on test material used for the study:

- Name of test material: barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate- Molecular formula: C18H14N2O6S.Ba- Molecular weight: 521.697 g/mol- Smiles notation: [Ba+2].c1c(c(c(c2ccccc12)\N=N\c1c(cc(cc1)C)S(=O)(=O)[O-])O)C(=O)[O-]- InChl: 1S/C18H14N2O6S.Ba/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;/h2-9,21H,1H3,(H,22,23)(H,24,25,26);/q;+2/p-2/b20-19+;- Substance type: Organic- Physical State: Solid

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

1. TEST ANIMALS- Source: National Institute of Biosciences, Pune.- Females were nulliparous and non-pregnant: yes- Age at study initiation: Female rats of the age of approximately 8 to 12 weeks old were used.- Weight at study initiation: Body weight range was 202.2 to 212.5 grams.Body weights at the start : Female Mean: 206.48 g (= 100 %); Minimum : 202.2 g (- 2.07 %); Maximum : 212.5 g (+ 2.92 %)- Fasting period before study: Approximately 16 hours or more.- Housing: The rats were housed in polycarbonate cages.- 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): 20.6 to 23.2 degree centigrade.- Humidity (%): 55.1% to 58.6%.- 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: 26-09-2016 to 15-10-20162. TEST ANIMALS- Source: National Institute of Biosciences, Pune.- Females (if applicable) nulliparous and non-pregnant: Yes- Age at study initiation: Female rats of the age of approximately 8 to 12 weeks old were used- Weight at study initiation: The weights were within ± 20% of the mean weight of any animal used for dosing. Body weight range was 189.4 to 201.1 grams- Body weights at the start : Female Mean: 195.31 g (= 100 %)Minimum: 189.4 g (- 3.03 %)Maximum: 201.1 g (+ 2.97 %)Total No. of animals : 12- Fasting period before study: Approximately 16 hours or more.- Housing: The rats were housed in polycarbonate cages.- 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): Room temperature was maintained at 20.1 to 22.7 degree centigrade.- Humidity (%): Room humidity was maintained at 55.1% to 61.2%.- Air changes (per hr): The animal room was independently provided with at least ten to fifteen air changes per hour of 100% fresh air that had been passed through the HEPA filters. - Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.IN-LIFE DATES: No data available

Route of administration:

oral: gavage

Vehicle:

other: 1. water 2. Distilled water

Details on oral exposure:

1. VEHICLE- Concentration in vehicle: 300 mg/kg, 300 mg/kg, 2000 mg/kg and 2000 mg/kgMAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight.2. VEHICLEMAXIMUM DOSE VOLUME APPLIED: 10 ml per kg of body weight was considered the maximum volume which could be administered to a rat.

Doses:

1. Dose Group I : 300 mg/kg; Dose Group I : 300 mg/kg; Dose Group II : 2000 mg/kg; Dose Group II : 2000 mg/kg2. Dose Group I : 300 mg/kgDose Group II : 2000 mg/kg

No. of animals per sex per dose:

1. Three females were used at each step.2. Three females were used at each step.

Control animals:

other: 1. not specified 2. yes

Details on study design:

1. - Duration of observation period following administration: 14 days - Frequency of observations and weighing: Twice daily- Necropsy of survivors performed: yes- Other examinations performed: Clinical Observations and General Appearance: Animals were observed for clinical signs, mortality and morbidity, until sacrifice.Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at immediately (0 to 5 minutes), 5, 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.Body weights: Individual animal body weights were recorded, before fasting, prior to administration of the test item (fasting body weights), weekly thereafter and at termination on day 14. Weight changes were calculated and recorded.Gross Pathology: Necropsy was performed on all animals at the end of the study period on day 15. 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. Histopathology:No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed.2. - Duration of observation period following administration: 14 days - Frequency of observations and weighing: Twice daily- Necropsy of survivors performed: Yes- Other examinations performed: Clinical Observations and General Appearance:Animals were observed for clinical signs, mortality and morbidity, until sacrifice.Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at immediately (0 to 5 minutes), 5, 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.Body weights:Individual animal body weights were recorded, before fasting, prior to administration of the test item (fasting body weights), weekly thereafter and at termination on day 14. Weight changes were calculated and recorded.Gross Pathology:Necropsy was performed on all animals at the end of the study period on day 15. 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.

Statistics:

1. No data2. No data available

Preliminary study:

1. No data2. No data available

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

1. Group I Step I :Animals treated at the dose level of 300 mg/kg body weight: All animals survived through the study period of 14 days.Group I Step II :Animals treated at the dose level of 300 mg/kg body weight: All animals survived through the study period of 14 days.Group II Step I :Animals treated at the dose level of 2000 mg/kg body weight: All animals survived through the study period of 14 days.Group II Step II :Animals treated at the dose level of 2000 mg/kg body weight: All animals survived through the study period of 14 days. 2. Group I Step I:Animals treated at the dose level of 300 mg/kg body weight: All animals survived through the study period of 14 days.Group I Step II:Animals treated at the dose level of 300 mg/kg body weight: All animals survived through the study period of 14 days.Group II Step I:Animals treated at the dose level of 2000 mg/kg body weight: All animals survived through the study period of 14 days.Group II Step II:Animals treated at the dose level of 2000 mg/kg body weight : All animals survived through the study period of 14 days.

Clinical signs:

other: 1. Group I Step I :Animals treated at the dose level of 300 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days.Group I Step II :Animals treated at the dose level of 300 mg/kg body weight did not result in any si

Gross pathology:

1. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups.2. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups.

Other findings:

1. No data2. No data available

Interpretation of results:

other: Not classified

Conclusions:

According to CLP regulation, the test chemical barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS No. 17852-98-1) cannot be classified for acute oral toxicity, as the LD50 value is >2000 mg/kg bw.

Executive summary:

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no.: 17852-98-1). The studies are as mentioned below:

1.The study was designed and conducted to determine the acute oral toxicity profile of test chemical in Sprague Dawley rats. Initially, 3 female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, 3 female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional 3 female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg resulted in diarrhoea (reddish colour stools) in all animals with onset at 2 hours and no mortality after the dosing. As no mortality were observed at 24 hours after the dosing, hence additional 3 female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg resulted in diarrhoea (reddish colour stools) in all animals with onset at 2 hours and no mortality after the dosing. All animals from 300 mg/kg and 2000 mg/kg dose groups survived through the study period of 14 days. Staining of the stool is attributed to the reddish colour of the test item. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups. The acute oral LD50 of test chemical was >2000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category Not classified” criteria of CLP.

2. The acute oral toxicity study was designed and conducted by using test chemical in Sprague Dawley rats. Initially, 3 female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, 3 female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional 3 female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. As no mortality were observed at 24 hours after the dosing, hence additional 3 female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups. It was concluded that the acute oral median lethal dose (LD50) of test chemical, when administered to Sprague Dawley rats was considered to be >2000 mg/kg body weight and falls into the “Category Not classified” criteria of CLP.

Thus, based on the above summarised studies, barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no.: 17852-98-1) and it’s structurally similar read across substance, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate cannot be classified for acute oral toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from study report

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Quality of whole database:

Waiver

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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

Remarks:

Experimental data of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar 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 two acute dermal toxicity studies as- WoE 2.and WoE 3. Acute dermal toxicity test was carried out to study the effects of the test chemicals on rodents

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Specific details on test material used for the study:

- Name of test material: barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate- Molecular formula: C18H14N2O6S.Ba- Molecular weight: 521.697 g/mol- Smiles notation: [Ba+2].c1c(c(c(c2ccccc12)\N=N\c1c(cc(cc1)C)S(=O)(=O)[O-])O)C(=O)[O-]- InChl: 1S/C18H14N2O6S.Ba/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;/h2-9,21H,1H3,(H,22,23)(H,24,25,26);/q;+2/p-2/b20-19+;- Substance type: Organic- Physical State: Solid

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

1. TEST ANIMALS- Source: National Institute of Biosciences, Pune.- Females (if applicable) nulliparous and non-pregnant: [no]- 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 211.4 to 246.3 grams at initiation of dosing were used. Body weights at the start : Male Mean : 240.62 g (= 100 %); Minimum: 236.8 g (- 1.59 %); Maximum: 246.3 g (+ 2.36 %)Female Mean : 216.02 g (= 100 %); Minimum: 211.4 g (- 2.14 %); Maximum: 220.6 g (+ 2.12 %)- 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): Room temperature was maintained at 20.1 to 21.9 degree centigrade.- Humidity (%): Room humidity was maintained at 55.5% to 59.2%.- Air changes (per hr): The animal room was independently provided with at least ten to fifteen air changes per hour of 100% fresh air that had been passed through the HEPA filters.- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.2. TEST ANIMALS- Source: National Institute of Biosciences, Pune.- Females (if applicable) nulliparous and non-pregnant: [no]- 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 201.4 to 232.7 grams at initiation of dosing were used. Body weights at the start : Male Mean: 222.62 g (= 100 %); Minimum : 216.7 g (- 2.66 %); Maximum : 232.7 g (+ 4.53 %)Female Mean: 207.88 g (= 100 %); Minimum : 201.4 g (- 3.12 %); Maximum : 218.1 g (+ 4.92 %)- 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): Room temperature was maintained at 20.1 to 21.9 degree centigrade.- Humidity (%): Room humidity was maintained at 55.5% to 59.2%.- Air changes (per hr): The animal room was independently provided with at least ten to fifteen air changes per hour of 100% fresh air that had been passed through the HEPA filters.- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

1. TEST SITE - Area of exposure: 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. TEST MATERIAL - Amount(s) applied (volume or weight with unit): 2000 mg/kg bw2. TEST SITE - Area of exposure: 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. TEST MATERIAL - Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

Duration of exposure:

1. 24 hours2. 24 hours

Doses:

1. A single dose of 2000 mg of the test item per kilogram of body weight was administered to ten rats (five males and five females).2. A single dose of 2000 mg of the test item per kilogram of body weight was administered to ten rats (five males and five females).

No. of animals per sex per dose:

1. 10 (5/sex). 2. 10 (5/sex).

Control animals:

other: 1. yes 2. yes

Details on study design:

1. - Duration of observation period following administration: 14 days - Frequency of observations and weighing: Twice daily - Necropsy of survivors performed: Yes - Other examinations performed: 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 observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter 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, respiratory, circulatory system and behavior pattern. Evaluation of Dermal Reaction: Dermal reaction was observed daily for study period of 14 days. 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). 2. - Duration of observation period following administration: 14 days - Frequency of observations and weighing: Twice daily - Necropsy of survivors performed: Yes - Other examinations performed: 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 observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter 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, respiratory, circulatory system and behavior pattern. Evaluation of Dermal Reaction: Dermal reaction was observed daily for study period of 14 days. 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).

Statistics:

1. No data2. No data

Preliminary study:

1. No data2. No data

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

1. Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg: All animals survived through the study period of 14 days.Sex : Female Group I – Animal treated at the dose level of 2000 mg/kg: All animals survived through the study period of 14 days.2. Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg: All animals survived through the study period of 14 days.Sex : Female Group I – Animal treated at the dose level of 2000 mg/kg: All animals survived through the study period of 14 days.

Clinical signs:

other: 1. Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity 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 resul

Gross pathology:

1. Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group.2. Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group.

Other findings:

1. - Other observations: Evaluation of Dermal ReactionSex : 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. 2. - Other observations: Evaluation of Dermal ReactionSex : 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.

Interpretation of results:

other: Not classified

Conclusions:

According to CLP regulation the test chemical barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no.: 17852-98-1) cannot be classified for acute dermal toxicity, as the LD50 value is >2000 mg/kg bw

Executive summary:

Data available for the structurally similar read across chemicals has been reviewed to determine the Acute dermal toxicity of the test chemical barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no.: 17852-98-1).The studies are as mentioned below:

1. The study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. 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. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not exhibits acute toxicity by the dermal route.

2. The study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. 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. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not exhibits acute toxicity by the dermal route.

Thus, based on the above summarised studies, barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no.: 17852-98-1) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate cannot be classified for acute dermal toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from study report.

Additional information

Acute oral Toxicity: 

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no.: 17852-98-1). The studies are as mentioned below:

1. The study was designed and conducted to determine the acute oral toxicity profile of test chemical in Sprague Dawley rats. Initially, 3 female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, 3 female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional 3 female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg resulted in diarrhoea (reddish colour stools) in all animals with onset at 2 hours and no mortality after the dosing. As no mortality were observed at 24 hours after the dosing, hence additional 3 female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg resulted in diarrhoea (reddish colour stools) in all animals with onset at 2 hours and no mortality after the dosing. All animals from 300 mg/kg and 2000 mg/kg dose groups survived through the study period of 14 days. Staining of the stool is attributed to the reddish colour of the test item. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups. The acute oral LD50 of test chemical was >2000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category Not classified” criteria of CLP.

2. The acute oral toxicity study was designed and conducted by using test chemical in Sprague Dawley rats. Initially, 3 female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, 3 female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional 3 female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. As no mortality were observed at 24 hours after the dosing, hence additional 3 female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups. It was concluded that the acute oral median lethal dose (LD50) of test chemical, when administered to Sprague Dawley rats was considered to be >2000 mg/kg body weight and falls into the “Category Not classified” criteria of CLP.

Thus, based on the above summarised studies, barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no.: 17852-98-1) and it’s structurally similar read across substance, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate cannot be classified for acute oral toxicity.

Acute Inhalation Toxicity:

Barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no.: 17852-98-1) has very low vapour pressure (1.32E-18 mmHg), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver.

Acute dermal Toxicity: 

Data available for the structurally similar read across chemicals has been reviewed to determine the Acute dermal toxicity of the test chemical barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no.: 17852-98-1).The studies are as mentioned below:

1. The study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. 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. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not exhibits acute toxicity by the dermal route.

2. The study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. 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. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not exhibits acute toxicity by the dermal route.

Thus, based on the above summarised studies, barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no.: 17852-98-1) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate cannot be classified for acute dermal toxicity.

Justification for classification or non-classification

Based on the above experimental studies on barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no.: 17852-98-1) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw for acute oral and dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate cannot be classified for acute oral and dermal toxicity. For acute inhalation toxicity wavier were added so, not possible to classify.