Disodium [N-[7-hydroxy-8-[(2-hydroxy-5-mesylphenyl)azo]-1-naphthyl]acetamidato(2-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(2-)

Endpoint summary

Description of key information

The acute oral LD50 in rats 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

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 toxicity: oral

The acute oral toxicity of a Similar substance 01 was evaluated in a limit test usingrats. 5 males and 5 females were administered a single dose of 5000 mg/kg bw orally. After administration of the compound, the animals were observed for 14 days. The acute oral LD50 in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.

Based on the read across principle(read-across from supporting substance -structural analogue or surrogate), the results can be considered assessment of the registered substance.

Justification for read across is detailed in the report attached to the IUCLID section 13.

 

Acute toxicity: inhalation

Currently no study to assess acute inhalation toxicity is available. But due to the intrinsic properties of the test item and the high values of the acute oral toxicity studies available no effect beside sensitization effects are expected via the inhalation route. Experience with similar chemical structures demonstrated that it is very unlikely that toxicity related to intrinsic properties of the test item only show up via the inhalation route and not via the oral-gastric route of exposure.

 

Acute toxicity: dermal

Currently no study to assess acute dermal toxicity is available.

But due to the intrinsic properties of the test item and the high values of the acute oral toxicity studies available no effects are expected via the dermal route. In addition, exposure of the test item to the skin of rabbits and mice in course of skin irritation and skin sensitization effects did not reveal any signs of toxicity. Since experience with similar chemical substances demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the test item only show up upon dermal exposure and not after systemic application further experiments to assess dermal toxicity are not taken into account.Therefore this endpoint will be waived.

Justification for classification or non-classification

Acute oral toxicity

According to the CLP Regulation 1272/2008/EC, 3.1.2.1 section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1:

Oral (mg/kg body weight)

Category 1: LD50 ≤ 5

Category 2: 5 <LD50 ≤ 50

Category 3: 50 < LD50 ≤ 300

Category 4: 300 < LD50 ≤ 2 000

The oral LD50 values are > 5000 mg/kg/body weight, on a Similar substance 01.

Based on the read across principle(read-across from supporting substance -structural analogue or surrogate), the results can be considered assessment of the registered substance.

Justification for read across is detailed in the report attached to the IUCLID section 13.

The registered substance is not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n.1272/2008.