Trisodium 2-[[6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate

Endpoint summary

Link to relevant study record(s)

Reference

Endpoint:

basic toxicokinetics, other

Type of information:

other: assessment from available information

Adequacy of study:

key study

Study period:

2017 - 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

no guideline required

Principles of method if other than guideline:

assessment from available information

GLP compliance:

no

Radiolabelling:

no

Conclusions:

According to current valid guidance the test substance with the result of LD50 in acute oral test higher than 2000 mg/kg is considered as non-toxic after single oral application. Reactive Orange 13 did not penetrate into the organism through the skin after single application.The test substance is considered to be non-irritating to the eye and skin of rabbit. The test substance elicited negative sensitising response in guinea pig.Any adverse effect on the health of animals after acute inhalation test showed that the test substance did not evoke systemic toxicity of organism after inhalation.According to results of acute exposition of the test substance Reactive Orange 13 the test substance did not penetrate through the respiratory tract, skin and digestive tract.After repeated oral administration of the test substance Reactive Orange 13 morphological alterations in the kidneys, gastrointestinal tract and lymph nodes were noted. Microscopically, an increased storage of hyaline bodies in the stomach of both sexes and kidneys of males was recorded with increasing dose. The findings in the kidneys persisted to the end of recovery period. After repeated oral administration the test substance is absorbed through the blood circulation and systemic effect occurs. Target organ of systemic toxicity seems to be kidneys.Results recorded during the reproduction part of Reproduction/Developmental Toxicity Screening Test and Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test with repeated oral administration showed that the test substance did not influenced reproduction parameters of males and females. Development of pups was not influenced by the test substance administration. After repeated oral administration the test substance did not penetrate into the testes and through the placental barrier.No data about metabolism and excretion of the test substance were found.

Description of key information

According to current valid guidance the test substance with the result of LD50 in acute oral test higher than 2000 mg/kg is considered as non-toxic after single oral application.

Reactive Orange 13 did not penetrate into the organism through the skin after single application.

The test substance is considered to be non-irritating to the eye and skin of rabbit.

The test substance elicited negative sensitising response in guinea pig.

Any adverse effect on the health of animals after acute inhalation test showed that the test substance did not evoke systemic toxicity of organism after inhalation.

According to results of acute exposition of the test substance Reactive Orange 13 the test substance did not penetrate through the respiratory tract, skin and digestive tract.

After repeated oral administration of the test substance Reactive Orange 13 morphological alterations in the kidneys, gastrointestinal tract and lymph nodes were noted. Microscopically, an increased storage of hyaline bodies in the stomach of both sexes and kidneys of males was recorded with increasing dose. The findings in the kidneys persisted to the end of recovery period.

After repeated oral administration the test substance is absorbed through the blood circulation and systemic effect occurs. Target organ of systemic toxicity seems to be kidneys.

Results recorded during the reproduction part of Reproduction/Developmental Toxicity Screening Test and Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test with repeated oral administration showed that the test substance did not influenced reproduction parameters of males and females. Development of pups was not influenced by the test substance administration.

After repeated oral administration the test substance did not penetrate into the testes and through the placental barrier.

No data about metabolism and excretion of the test substance were found.