Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates

Endpoint summary

Description of key information

Acute oral toxicity: 

The acute oral toxicity dose (LD50) for Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates was considered based on data available for the structurally and functionally similar read across chemicals. The LD50 value is >2000 mg/kg bw.Thus, comparing this value with the criteria of CLP regulation, Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates cannot be classified for acute oral toxicity. 

Acute Inhalation toxicity: 

The study need not to be conducted because the melting point of the test chemical Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates is above 300°C and has very low vapour pressure, 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 Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates was considered based on data available for the structurally and functionally similar read across chemicals. The LD50 value is >2000 mg/kg bw.Thus, comparing this value with the criteria of CLP regulation, Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates 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 and functionally 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 2 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

Species:

rat

Strain:

other: 1. not specified 2. Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

1. not specified2. not specified

Route of administration:

other: 1. oral: unspecified 2. oral: gavage

Vehicle:

other: 1. not specified 2. unchanged (no vehicle)

Details on oral exposure:

1. not specified2. not specified

Doses:

1. 2031 mg/kg2. 1210, 1820, 2420, 3030, 3750 or 6040 mg/kg

No. of animals per sex per dose:

1. not specified2. Total: 60 (10 male /dose)

Control animals:

not specified

Details on study design:

1. - Other examinations performed: Animals were observed for mortality and clinical signs.2. - Duration of observation period following administration: 14 days - Other examinations performed: clinical examination was performed.

Statistics:

1. not specified2. not specified

Preliminary study:

1. not specified2. not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

2 031 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality was observed

Sex:

male

Dose descriptor:

LD50

Effect level:

2 528 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality was observed

Mortality:

1. 50% mortality was observed at 2031 mg/kg bw2. Mortality was observed at 1820(2), 2420(5), 3030(6), 3750(9) and 6040(10) mg/kg. 50% mortality was observed at dose 2528 mg/kg

Clinical signs:

1. Clinical signs were observed as follows, regional or general arteriolar or venous dilation; behavioral changes; muscle weakness; changes in skin and appendages (skin), hairs and other.2. Signs of intoxication, sedation, extention spasm, reduced general condition of animals were observed.

Body weight:

1. not specified2. not specified

Gross pathology:

1. not specified2. not specified

Other findings:

1. not specified2. not specified

Interpretation of results:

other: Not classified

Conclusions:

According to CLP regulation the test chemical Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates cannot be classified for acute oral toxicity, as the LD50 value is >2000 mg/kg bw.

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates. The studies are as mentioned below:

1. The acute oral toxicity of test chemical was tested in rats at the dose concentration of 2031 mg/kg bw. Animals were observed for mortality and clinical signs. 50% mortality was observed at 2031 mg/kg bw. Clinical signs were observed as follows, regional or general arteriolar or venous dilation; behavioural changes; muscle weakness; changes in skin and appendages (skin), hairs and other. Hence, LD50 value was considered to be 2031 mg/kg bw, when rats were treated with test chemical via oral route.

2. Acute oral toxicity study was conducted in 60 (10/dose) male Wistar rats using undiluted test chemical. Doses were given in concentration 1210, 1820, 2420, 3030, 3750 or 6040 mg/kg via oral gavage route and observed for 14 days. Mortality was observed at 1820(2), 2420(5), 3030(6), 3750(9) and 6040(10) mg/kg. 50% mortality was observed at dose 2528 mg/kg bw with the signs of intoxication reported as, sedation, extension spasm, reduced general condition in animals were observed. Hence, LD50 was considered to be 2528 mg/kg bw, when male Wistar rats were treated with test chemical via oral route.

Thus, based on the above summarised studies, Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates and it’s structurally and functionally 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, Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates cannot be classified for acute oral toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 528 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from database.

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 and functionally 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 2 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 : Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates- Molecular formula :C8H22NO12P.Mo.W- Molecular weight : 635.02 g/mol- Smiles notation : CN(C)c1ccccc1_O=[Mo](=O)(O{-})O{-}_O=[W](=O)(O{-})O{-}_OP(O)(O)=O- Substance type: Organic- Physical state : Solid

Species:

other: 1. rabbit 2. rat

Strain:

other: 1. not specified 2. Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

1. not specified2. TEST ANIMALS- Age at study initiation: 8 to 10 weeks-Weight at study initiation: 200±20g- Identification : By cage tag and corresponding colour body marking- Randomization : After acclimation and Veterinary examination all the animals randomly divided into two groups and each group having five male and five female rats.- Fasting period before study: overnight- Housing: Groups of three animals of same sex in polypropylene cages with stainless steel grill top, facilities for food and water bottle, and bedding of clean paddy husk.- Diet (e.g. ad libitum): Pelleted feed supplied- Water (e.g. ad libitum): Fresh and clean water filtered through ‘Aqua Guard on line water filter’, was kept in glass bottles; Ad libitum.- Acclimation period: period of one week ENVIRONMENTAL CONDITIONS - Temperature (°C): 22-25 degC - Humidity (%): 40-60% - Air changes (per hr): Air conditioned rooms with 10-15 air changes per hour - Photoperiod (hrs dark / hrs light): illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.

Type of coverage:

other: 1. Dermal 2. open

Vehicle:

other: 1. not specified 2. water

Details on dermal exposure:

1. not specified2. TEST SITE - Area of exposure: Back skin of total body surface area - % coverage: 10 percent - Type of wrap if used: Adhesive tape REMOVAL OF TEST SUBSTANCE - Washing (if done): The site of application was cleaned with lukewarm water wiping the test compound. - Time after start of exposure: 24 hrs TEST MATERIAL - Amount(s) applied (volume or weight with unit): 2000 mg/kg b.wt

Duration of exposure:

1. 24 hrs2. 24 hours

Doses:

1. 1250, 2500 or 5000 mg/Kg2. Group I: 2000 mg/Kg bw; Group II: 2000 mg/Kg bw

No. of animals per sex per dose:

1. Total: 14; 1250 mg/Kg: 6; 2500 mg/Kg: 4; 5000 mg/Kg: 42. Total: 20Group I: 2000 mg/Kg bw: 10 (5 male & 5 female)Group II: 2000 mg/Kg bw: 10 (5 male & 5 female)

Control animals:

not specified

Details on study design:

1. - Duration of observation period following administration: 24 hrs- Other examinations performed: Clinical signs, mortality2. - Duration of observation period following administration: 14 days - Frequency of observations and weighing: Daily - Necropsy of survivors performed: yes - Other examinations performed: clinical signs, body weight and mortality.

Statistics:

1. not specified2. not specified

Preliminary study:

1. not specified2. not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

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. All 4 animals dosed at 5000 mg/kg died within 24 h. There was no mortality at the two lower doses.2. No incidence of mortality was observed in Wistar albino rats after application of test compound.

Clinical signs:

1. There were no clinical signs observed at any dose other than erythema and edema at the application site.2. The Wistar albino rats treated with the test compound showed moderate to severe clinical signs of intoxication, decrease in cage side activity, lacrimation and abdominal respiration. The local signs of dermal toxicity - erythema and edema were observed. This condition was observed upto 6 days from the day of application of test compound.

Body weight:

1. not specified2. The body weight of all the animals was recorded on day 0 (pre treatment) and then 7th and 14th (post treatment) showed slightly decrease on day 7th while normal increase on day 14th when compared to day 0.

Gross pathology:

1. not specified2. Necropsy finding did not reveal any significant gross pathological changes in any of the Wistar albino rat.

Other findings:

1. not specified2. not specified

Interpretation of results:

other: Not classified

Conclusions:

According to CLP regulation the test chemical Reaction mass of Benzenamine, N,N-dimethyl-, molybdate, tungstate & phosphates cannot be classified for acute dermal toxicity, as the LD50 value is >2000 mg/kg bw.

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute dermal toxicity of the test chemical Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates. The studies are as mentioned below:

1. Acute dermal toxicity study was conducted on rabbits to evaluate the dermal toxic nature of the test compound. The rabbits were given the doses of 1250 (n = 6), 2500 (n = 4) and 5000 (n = 4) mg/kg. There was no mortality at the two lower doses. There were no clinical signs observed at any dose other than erythema and edema at the application site. It was concluded that the acute dermal median lethal dose (LD50) of test chemical when administered to rabbits was considered to be >2500 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not exhibit acute toxicity by the dermal route.

2. The acute dermal toxicity study of test chemical was performed on 20 male and female wistar rats according to OECD guideline-402. Approximate 10% back skin of total body surface area was prepared 24 hr prior to application of test material. Test material in dose concentration 2000 mg/kg bw applied for 24 hr in group I and group II animals. All the animals were acclimation for period of one week and provided with Fresh and clean water filtered through ‘Aqua Guard on line water filter’, was kept in glass bottles; Ad libitum. All animals were observed for clinical signs, body weight and mortality. The necropsy was performed on all animals at termination of the study. No incidence of mortality was observed in Wistar albino rats after application of test compound. The Wistar albino rats treated with the test compound showed moderate to severe clinical signs of intoxication, decrease in cage side activity, lacrimation and abdominal respiration. The local signs of dermal toxicity - erythema and edema were observed. This condition was observed upto 6 days from the day of application of test compound. The body weight of all the animals was recorded on day 0 (pre treatment) and then 7th and 14th (post treatment) showed slightly decrease on day 7th while normal increase on day 14th when compared to day 0. Necropsy finding did not reveal any significant gross pathological changes in any of the Wistar albino rat. Hence the acute dermal LD50 was considered to be >2000 mg/kg b.wt., When Wistar albino rats were treated with test chemical applied by dermal route.

Thus, based on the above summarised studies, Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates 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, Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates cannot be classified for acute dermal toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from peer reviewed journal.

Additional information

Acute oral toxicity:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates. The studies are as mentioned below:

1. The acute oral toxicity of test chemical was tested in rats at the dose concentration of 2031 mg/kg bw. Animals were observed for mortality and clinical signs. 50% mortality was observed at 2031 mg/kg bw. Clinical signs were observed as follows, regional or general arteriolar or venous dilation; behavioural changes; muscle weakness; changes in skin and appendages (skin), hairs and other. Hence, LD50 value was considered to be 2031 mg/kg bw, when rats were treated with test chemical via oral route.

2. Acute oral toxicity study was conducted in 60 (10/dose) male Wistar rats using undiluted test chemical. Doses were given in concentration 1210, 1820, 2420, 3030, 3750 or 6040 mg/kg via oral gavage route and observed for 14 days. Mortality was observed at 1820(2), 2420(5), 3030(6), 3750(9) and 6040(10) mg/kg. 50% mortality was observed at dose 2528 mg/kg bw with the signs of intoxication reported as, sedation, extension spasm, reduced general condition in animals were observed. Hence, LD50 was considered to be 2528 mg/kg bw, when male Wistar rats were treated with test chemical via oral route.

Thus, based on the above summarised studies, Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates and it’s structurally and functionally 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, Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates cannot be classified for acute oral toxicity.

Acute Inhalation toxicity: 

The study need not to be conducted because the melting point of the test chemical Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates is above 300°C and has very low vapour pressure, 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 and functionally similar read across chemicals has been reviewed to determine the acute dermal toxicity of the test chemical Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates. The studies are as mentioned below:

1. Acute dermal toxicity study was conducted on rabbits to evaluate the dermal toxic nature of the test compound. The rabbits were given the doses of 1250 (n = 6), 2500 (n = 4) and 5000 (n = 4) mg/kg. There was no mortality at the two lower doses. There were no clinical signs observed at any dose other than erythema and edema at the application site. It was concluded that the acute dermal median lethal dose (LD50) of test chemical when administered to rabbits was considered to be >2500 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not exhibit acute toxicity by the dermal route.

2. The acute dermal toxicity study of test chemical was performed on 20 male and female wistar rats according to OECD guideline-402. Approximate 10% back skin of total body surface area was prepared 24 hr prior to application of test material. Test material in dose concentration 2000 mg/kg bw applied for 24 hr in group I and group II animals. All the animals were acclimation for period of one week and provided with Fresh and clean water filtered through ‘Aqua Guard on line water filter’, was kept in glass bottles; Ad libitum. All animals were observed for clinical signs, body weight and mortality. The necropsy was performed on all animals at termination of the study. No incidence of mortality was observed in Wistar albino rats after application of test compound. The Wistar albino rats treated with the test compound showed moderate to severe clinical signs of intoxication, decrease in cage side activity, lacrimation and abdominal respiration. The local signs of dermal toxicity - erythema and edema were observed. This condition was observed upto 6 days from the day of application of test compound. The body weight of all the animals was recorded on day 0 (pre treatment) and then 7th and 14th (post treatment) showed slightly decrease on day 7th while normal increase on day 14th when compared to day 0. Necropsy finding did not reveal any significant gross pathological changes in any of the Wistar albino rat. Hence the acute dermal LD50 was considered to be >2000 mg/kg b.wt., When Wistar albino rats were treated with test chemical applied by dermal route.

Thus, based on the above summarised studies, Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates 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, Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates cannot be classified for acute dermal toxicity.

Justification for classification or non-classification

Based on the above studies, Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates and it’s structurally and functionally 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, Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates cannot be classified for acute oral and dermal toxicity. For acute inhalation toxicity wavier were added so, not possible to classify.