Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate

Endpoint summary

Description of key information

I.F. Gaunt, Madge Farmer, P. Grasso, S.D. Gangolli (1967) was performed on male and female ICI Alderley Park Strain 1 SPF mouse. At concentration of 2000 mg/kg and observed for 14 days. 10 mice/sex were used. The LD50values with 95 % confidence limits were calculated according to Litchfield & Wilcoxon. No toxic signs or deaths were observed during study. Therefore, the LD 50 value of Brilliant Black PN was found to be >2000 mg/kg for mice. 

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:

key study

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

other: as per mentioned below

Principles of method if other than guideline:

Oral dosages of compound were administered by oral intubation to the mouse. Animals were observed usually for 14 days during which time the development of toxic signs was followed and time of death recorded.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

mouse

Strain:

other: ICI Alderley Park Strain 1 SPF

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: No data available- Age at study initiation: No data available- Weight at study initiation: No data available- Fasting period before study: 18 hr prior to dosing- Housing: No data available- Diet (e.g. ad libitum): No data available- Water (e.g. ad libitum): No data available- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

No data available

Doses:

no data

No. of animals per sex per dose:

10 mice/sex

Control animals:

yes

Details on study design:

no data available

Statistics:

LD50 values with 95 % confidence limits were calculated according to Litchfield & Wllcoxon (1949).

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: with 95 %confidence limits

Mortality:

No mortality observed

Clinical signs:

other: no toxic signs observed

Gross pathology:

No data available

Other findings:

Orally, a substantial amount of coloured material was excreted in the faeces.

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

In acute toxicity study by oral route the LD50 value for the Brilliant Black PN was found to be >2000 mg/kg for mice.

Executive summary:

Acute toxicity test was performed on mice at concentration of 2000 mg/kg and observed for 14 days.10 mice/sex were used. The LD₅₀values with 95 % confidence limits were calculated according to Litchfield & Wilcoxon. No toxic signs or deaths were observed during study.

 

Therefore, the LD 50 value of Brilliant Black PN was found to be >2000 mg/kg for mice.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Data is from peer reviewed publication

Additional information

Acute oral toxicity:

Several studies for the target chemical Brilliant Black PN and Read across Acid Red 1were reviewed to determine the acute oral toxic nature of the test compound (CAS no 2519-30-4). The studies are summarized as below:

 

I.F. Gaunt, Madge Farmer, P. Grasso, S.D. Gangolli (1967) was performed on male and female ICI Alderley Park Strain 1 SPF mouse.At concentration of 2000 mg/kg and observed for 14 days.10 mice/sex were used. The LD₅₀values with 95 % confidence limits were calculated according to Litchfield & Wilcoxon. No toxic signs or deaths were observed during study.Therefore, the LD 50 value of Brilliant Black PN was found to be >2000 mg/kg for mice.

 

Acute toxicity test (I.F. Gaunt, Madge Farmer, P. Grasso, S.D. Gangolli, 1967) was performed on rats at concentration of 5000 mg/kg and observed for 14 days.5 rats/sex were used. The LD50 values with 95 % confidence limits were calculated according to Litchfield & Wilcoxon. No toxic signs or deaths were observed during study. Therefore, the LD50 value for the brilliant black 1 was found to be >5000 mg/kg for rat.

 

In Long-term Feeding Study on Black PN in Rats, 1972 and Joint FAO/WHO Expert Committee on Food Additives, 2016, acute oral toxicity test was conducted on mouse exposed to Black PN by oral route. LD50 value was found to be >5000 mg/kg in acute oral toxicity of chemical Black PN administered to mouse by oral route.

 

The acute median lethal dose (LD50) value of Brilliant black 1 in mouse as predicted by Danish Quantitative Structute Activity Relationship Model (2016) is estimated to be19000mg/kg bwadministered to mouse by oral route. 

 

Acute oral toxicity study was conducted (summary of toxicological data of certain food additives – red 2g, 1977) in rats, guinea pigs and rabbits. 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.

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.

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 be 4810 (3160-7350) mg/kg in guinea pigs.

 

Acute oral toxicity study was conducted (summary of toxicological data of certain food additives – red 2g, 1977) in rats, rabbits and guinea-pigs. 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 be greater than 5000 mg/kg in rabbits.

 

Acute Oral study (summary of toxicological data of certain food additives – red 2g, 1977)was carried out on chicken. Chicken were administered RED 2G orally through gavage and toxic signs were observed. The acute oral LD50 for RED 2G was determined to be greater than 10000 mg/kg in chicken.

 

The above mentioned studies indicate that the substance is not expected to exhibit acute toxicity by oral route as per the CLP criteria.

Justification for selection of acute toxicity – oral endpoint
In acute toxicity study by oral route the LD50 value for the Brilliant Black PN was found to be >2000 mg/kg for mice.