4'-aminoazobenzene-4-sulphonic acid

Endpoint summary

Description of key information

Acute oral toxicity: 

 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is between the range 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical is classified in category 4 for acute oral toxicity.

 

Acute Inhalation Toxicity:

 

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 1.88E-9 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. 

 

Acute Dermal toxicity:

 

The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical 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:

calculation (if not (Q)SAR)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Justification for type of information:

Data is from Danish QSAR.

Qualifier:

according to guideline

Guideline:

other: Predicted data

Principles of method if other than guideline:

Prediction is done by using Danish QSAR

GLP compliance:

not specified

Test type:

other: Not specified

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

Not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

Not specified

Doses:

490 mg/kg bw

No. of animals per sex per dose:

Not specified

Control animals:

not specified

Details on study design:

Not specified

Statistics:

Not specified

Preliminary study:

Not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

490 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% Mortality observed

Mortality:

50% mortality observed

Clinical signs:

other: Not specified

Gross pathology:

Not specified

Other findings:

Not specified

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

LD50 was estimated to be 490 mg/kg bw, when rats were treated with test material via oral route

Executive summary:

Based on the QSAR prediction done using the Danish (Q)SAR Database, the acute oral toxicity was estimated for with test material. The LD50 was estimated to be 490 mg/kg bw with Reliability Index 0.57 (0.5-0.75 = moderate prediction quality), when rats were treated with test material via oral route.

Endpoint conclusion

Endpoint conclusion:

no study available

Dose descriptor:

LD50

Value:

490 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from prediction 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 from various test chemicals

Justification for type of information:

Data is summarized based on the available information from various test 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:

yes

Species:

other: 1) Rat 2) Rabbit

Strain:

other: 1) Not specified 2)Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

1) Not specified
2)- Source: National Institute of Biosciences, Pune a registered source as approved by the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA).
- Age at study initiation: 8 – 12 weeks
- Weight at study initiation: 221.7 to 255.3 grams
- Fasting period before study: No data
- Housing: polycarbonate cages with paddy husk as bedding
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune
- Water (e.g. ad libitum): All water was from a local source and passed through the reverse osmosis membrane before use. individual bottles were attached to the cages
- Acclimation period: 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

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 to 22.5 degree centigrade
- Humidity (%):53.2% to 58.8%.
- Air changes (per hr): ten to fifteen air changes per hour of 100% fresh air that had been passed through the HEPA filters
- Photoperiod (hrs dark / hrs light): light and dark cycle of 12 hours

Type of coverage:

other: 1) Not specified 2) Semi occlusive

Vehicle:

other: 1) Not specified 2) Diistilled water

Details on dermal exposure:

1) Not specified
2)VEHICLE
- Concentration in vehicle: 2000 mg/kg
- Amount of vehicle : No data
- Justification for choice of vehicle: No data
- Lot/batch no.: No data
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

DOSAGE PREPARATION : No data

Duration of exposure:

1) Not specified
2) 24 hrs

Doses:

1) 4000 mg/kg bw
2) 2000 mg/kg bw

No. of animals per sex per dose:

1) Not specified
2) 10(5/sex)

Control animals:

not specified

Details on study design:

1) Not specified
2)- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: No clinical signs observed

Statistics:

1) Not specified
2) Not specified

Preliminary study:

1) Not specified
2) Not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

4 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 mL/kg bw

Based on:

test mat.

Mortality:

1) Not specified
2) No mortality observed

Clinical signs:

other: 1) Not specified 2) No clinical signs observed

Gross pathology:

1) Not specified
2) No abnormalities observed

Other findings:

1) Not specified
2) Not specified

Interpretation of results:

other: Not classified

Conclusions:

According to CLP regulation, the test chemical cannot be classified for acute dermal toxicity, as the LD50 value is >2000 mg/kg bw.

Executive summary:

 In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats and rabbits for test chemical. The studies are summarized as below –

 

1)Acute dermal toxicity study of test chemical was conducted on rabbits at the dose concentration of 4000 mg/kg bw. The test chemical was administered dermally. All animals were maintained under close observation for recording toxic signs and time of death . Therefore, LD50 value was considered to be >4000 mg/kg bw, when rabbits were treated with test chemical via dermal application.

2)The study now reported 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 found to be greater than 2000 mg/kg body weight.Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant.

 

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Endpoint conclusion

Endpoint conclusion:

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:

 

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical. The studies are summarized as below –

 

1. Based on the QSAR prediction done using the Danish (Q)SAR Database, the acute oral toxicity was estimated for with test chemical. The LD50 was estimated to be 490 mg/kg bw with Reliability Index 0.57 (0.5-0.75 = moderate prediction quality), when rats were treated with test material via oral route.

 

2. Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 1000 mg/kg bw. The test chemical was administered via oral route. All animals were maintained under close observation for recording toxic signs and time of death . Therefore, LD50 value was considered to be 1000 mg/kg bw, when rats were treated with test chemical via oral route.

 

3. Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 900 mg/kg bw. The test chemical was administered via oral route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Clinical signs of Liver damage, functional disturbances to the kidneys, effects to the CNS and cardiovascular disturbances were observed during the 14 days study. Therefore, LD50 value was considered to be 900 mg/kg bw, when rats were treated with test chemical via oral route.

 

Thus, based on the above summarized studies on test chemical, it can be concluded that LD50 value is in the range 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified as category 4 for acute oral toxicity.

 

Acute Inhalation Toxicity:

 

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 1.88E-9 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. 

 

Acute Dermal Toxicity:

 

 

 In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats and rabbits for test chemical. The studies are summarized as below –

 

1)Acute dermal toxicity study of test chemical was conducted on rabbits at the dose concentration of 4000 mg/kg bw. The test chemical was administered dermally. All animals were maintained under close observation for recording toxic signs and time of death . Therefore, LD50 value was considered to be >4000 mg/kg bw, when rabbits were treated with test chemical via dermal application.

 

2)The study now reported 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 found to be greater than 2000 mg/kg body weight.Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant.

 

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that LD50 value is between the range 300-2000 mg/kg bw for acute oral toxicity and >2000 mg/kg bw for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical is classified as Category 4 for acute oral toxicity and not classified for acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.