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

Endpoint summary

Description of key information

Acute oral toxicity:

LD50 was considered to be > 10800 mg/kg bw when rat was treated with Lithol Rubine B orally.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

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:

Data is from Authorized database

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

Acute oral toxicity study of Lithol Rubine B in rat

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 (as cited in study report):Lithol Rubine B - Molecular formula (if other than submission substance):C18H14N2O6S.2Na- Molecular weight (if other than submission substance):432.38 g/mole- Substance type:Organic

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:

10800 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:

> 10 800 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality observed

Mortality:

No mortality was observed in treated rat at 10800 mg/kg bw

Clinical signs:

other: not specified

Gross pathology:

not specified

Other findings:

not specified

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

LD50 was considered to be > 10800 mg/kg bw when rat was treated with Lithol Rubine B orally.

Executive summary:

In a acute oral toxicity study, rat were treated with Lithol Rubine B in the concentration of 10800 mg/kg bw,No mortality was observed in treated rat at 10800 mg/kg bw. Therefore,LD50 was considered to be > 10800 mg/kg bw when rat was treated with Lithol Rubine B orally.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 800 mg/kg bw

Quality of whole database:

Data is Kimisch 2 and from Authorized 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:

In different studies, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rats and mice for disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate along with the study available on structurally similar read across substance Carmoisine (CAS: 3567-69-9). The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies.

In a experimental study summarized by CCOSH (Canadian Centre for Occupational Health & Safety, RTECS Number QJ1975000, 2017) and Scientific Committee on Cosmetic Products (COLIPA, SCCNFP, 2004), rat were treated with Lithol Rubine B in the concentration of 10800 mg/kg bw, No mortality was observed in treated rat at 10800 mg/kg bw. Therefore, LD50 was considered to be > 10800 mg/kg bw when rat was treated with Lithol Rubine B orally.

In another prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute oral toxicity was estimated for disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate. The LD50 was estimated to be 7649 mg/kg bw when rats were orally exposed with disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate.

In another experimental study conducted by Gauntet al(Food Cosmetics. Toxicology. Vol. 5, pp. 179-185. 1967) on structurally similar read across substance Carmoisine (CAS no 3567-69-9), ICI Alderley Park male and female mice were treated with Carmoisine upto 8000 mg/kg orally by gavage in water and observed for 7 days. No mortalities were observed in any of the animal upto dose 8000 mg/kg. Therefore, LD50 was considered to be > 8000 mg/kg bw when ICI Alderley Park male and female mice were treated with Carmoisine orally by gavage.

Further supported by experimental study conducted by Lamiaet al(International Journal of Pharm Tech Research,Vol.9, No.4, pp 364-367, 2016) on structurally similar read across substance Carmoisine (CAS no 3567-69-9), Sprague- Dawly white male mice were treated with Carmoisine in the concentration of 1250,2500,3750,5000 and 6250 mg/kg orally. At 3750 mg/kg, 2 mice were died, at 5000 mg/kg , 5 mice were died and at 6250 mg/kg, 6 mice were died. Signs of loss of appetite drowsiness, tachycardia, decrease in locomotion & anorexia was distinctive signs were observed in the dead mice. Therefore, LD50 was considered to be 4166.66 mg/kg bw when male mice were treated Carmoisine orally.

Thus, based on the above studies and predictions on disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate and its read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate can be classified as category V of acute oral toxicity.

Justification for classification or non-classification

Based on the above studies and predictions on disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate and its read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate can be classified as category V of acute oral toxicity.