Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate

Endpoint summary

Description of key information

Based on the QSAR prediction done using the Danish (Q)SAR Database, the LD50 was estimated to be 3700 mg/kg/d on rat for substance disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate. Thus based on this value it can be concluded that the substance can be classified as non toxic as per the criteria of CLP regulation.

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)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from modelling database developed by the National Food Institute, Technical University of Denmark.

Principles of method if other than guideline:

Data is predicted using the Danish (Q)SAR Database

GLP compliance:

no

Test type:

standard acute method

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Control animals:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

3 700 mg/kg bw

Based on:

test mat.

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

Based on the QSAR prediction done using the Danish (Q)SAR Database, the LD50 was estimated to be 3700 mg/kg/d on rat for substance disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate. Thus based on this value it can be concluded that the substance can be classified as non toxic as per the criteria of CLP regulation.

Executive summary:

Based on the QSAR prediction done using the Danish (Q)SAR Database, the LD50 was estimated to be3700 mg/kg/don rat for substance disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate. Thus based on this value it can be concluded that the substance can be classified as non toxic as per the criteria of CLP regulation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 700 mg/kg bw

Quality of whole database:

Data is predicted using the Danish (Q)SAR Database

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

Applying weight of evidence approach to the available predicted and experimental data for the target as well as read-across chemical, the information is summarised as below

In the Acute oral test ,predicted byDanish (Q) SAR Database3700 mg/kg of D & C Red no. 33 was used to find the LD50 in rats.TheLD50 was estimated to be3700 mg/kg/don rat for substance disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate by Danish (Q) SAR Database .

In the Acute oral test was observed in rat. The acute oral LD50 value of D & C Red no. 33 is considered to be >3160 mg/kg bw in rat.

In another study (DuPont Chem Company,1992) with similar substance (CAS:6406-56-0),the test was conducted in ChR-CD male rat. Test substance was administered 7500, 8000, 8500 and 9500 mg/kg by  oral gavage to four groups of ten rat. After 14 days observation, Mortality observed 2/10 at dose 7500 mg/kg; 9/10 at 8000 and 8500 mg/kg. Therefore the acute oral L50 value of C.I. Acid Red 151 is considered to be 7736 mg/kg in male rat.

In another study (WHO Technical Report Series No. 617, 1997) with similar substance (CAS: 3734-67-6), Acute Oral study was carried out on rats. Rats were administered RED 2G orally through gavage and toxic signs were observed. Histological studies in rats showed extensive renal necrosis. The acute oral LD50 for RED 2G was found to be greater than 5000mg/kg.

In another study (WHO Technical Report Series No. 617, 1997) with similar substance (CAS: 3734-67-6) Acute Oral studies were carried out on mice. Mice were administered RED 2G orally through gavage and toxic signs were observed. There was gross leptomeningeal vascular engorgement and focal sub-arachnoid haemorrhage observed in the treated mice. The acute oral LD50 for RED 2G was found to be 7350mg/kg in mice.

In another study (WHO Technical Report Series No. 617, 1997) with similar substance (CAS: 3734-67-6) Acute Oral studies were carried out in guinea-pigs. Guinea Pigs were administered RED 2G orally through gavage and toxic signs were observed. Histological studies in guinea pigs showed extensive renal necrosis. The acute oral LD50 for RED 2G was found to be4810 (3160-7350) mg/kg in guinea pigs.

In another study (WHO Technical Report Series No. 617, 1997) with similar substance (CAS: 3734-67-6) Acute Oral studies were carried out in rabbit. A dose of 5 g/kg body weight was administered on each of two successive days to a rabbit weighing 3.8 kg and a dose of 25 g/kg body weight was administered on each of two successive days to a rabbit weighing 4.3 kg. No signs of toxicity were observed and their red cells contained no Heinz bodies. Histological studies in guinea pigs showed extensive renal necrosis. The acute oral LD50 for RED 2G was found to begreater than 5000 mg/kg in rabbits.

In another study (I. F. GAUNT et.al; 1967) with similar substance (CAS: 3567-69-9). Acute oral toxicity test was conducted onCarworth Farm E strain 5 male and 5 female rat exposed by chemical Carmoisine orally by stomach tube.Aqueous solutions of Carmoisine were administered in single doses by stomach tube at dosage volumes of 10 ml/kg.Observations of toxic signs and deaths were made for 7 days after dosage,In both sexes of rats oral doses of up to and 10,000 mg/kg in rats were tolerated without lethal effect. Hence, LD50 value was observed to be >10,000 mg/kg in acute oral toxicity test of chemical Carmoisine exposed to rat orally by stomach tube.

In another study (I. F. GAUNT et.al; 1967) with similar substance (CAS: 3567-69-9).Acute oral toxicity test was conducted onICI Alderley Park strain of 5 male and 5 female mice exposed by chemicalCarmoisine orally by stomach tube. Aqueous solutions of Carmoisine were administered in single doses by stomach tube at dosage volumes of 10 ml/kg. Observations of toxic signs and deaths were made for 7 days after dosage,In both sexes of rats oral doses of up to and 8000 mg/kg in mice were tolerated without lethal effect.LD50 value was observed to be >8000 mg/kg in acute oral toxicity test of chemical Carmoisine exposed to mice orally by stomach tube.

In another study (Lamia A. M. Ai-Mashhedyet.al, 2016) with similar substance (CAS: 3567-69-9). Acute oral toxicity test has been performed in 72-male Sprague- Dawley white mice .They  were exposed to chemical carmoisine with dose concentration of 1250 mg/kg, 2500 mg/kg, 3750 mg/kg, 5000 mg/kg, 6250 mg/kg to 6 animals per dose by oral route. Control animals received distilled water only. The mice were observed for 3 days for the signs and symptoms of toxicity as well as the death rate of each group were recorded. In the animals that received different doses of the carmoisine dye ranging from (1250 to 6250 mg/Kg) administered orally in a single dose by stomach tube, the signs of loss of appetite drowsiness, tachycardia, decrease in locomotion & anorexia was distinctive signs observed on the mice before dead. Where LD50 value was found to be 4166.66 mg/kgbw. Hence, The LD50 value of chemical carmoisine was found to be 4166.66 mg/kg bw in acute oral toxicity test conducted on male Sprague- Dawley white mice for 3 days. On the basis of available information for the target as well as read across substance and applying weight of evidence approach, the test substance cannot be considered as acute oral toxicant, in accordance with the CLP criteria. Overall reported acute toxicity studies of chemical substance as well as its read-across substance and applying weight of evidence , indicate that the substance is not likely to exhibit acute oral toxicity can be classified as 'non-hazardous' as per the CLP classification criteria. 

Justification for selection of acute toxicity – oral endpoint
Based on the QSAR prediction done using the Danish (Q)SAR Database, the LD50 was estimated to be 3700 mg/kg/d on rat for substance disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate. Thus based on this value it can be concluded that the substance can be classified as non toxic as per the criteria of CLP regulation.

Justification for classification or non-classification

Based on the LD50 values determined forD & C Red no. 33in various studies for target and read across, it can be concluded that the test substance is not likely to be toxic by oral route and can be classified as non-hazardous for acute oral toxicity as per the CLP criteria