Trisodium [3-[[4-[[6-anilino-1-hydroxy-4-sulpho-2-naphthyl]azo]-5-hydroxy-o-tolyl]azo]naphthalene-1,5-disulphonato(5-)]cuprate(3-)

Endpoint summary

Description of key information

LD50 (oral) = 4028 mg/kg
LD50 (dermal) > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The complete read across justification is detailed in section 13. Test substance is an isomer of the substance under registration; structural difference is not expected to significantly impact the acute toxicity potential. Source study has reliability 2: only limited information available from a migrated NONS file, as per Article 25(3) request.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

No information on the method is available

GLP compliance:

yes

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 4 028 mg/kg bw

Based on:

not specified

Clinical signs:

other:

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 = 4028 mg/kg bw

Executive summary:

Method

Test conducted according to OECD guideline 401. No details on method are available. Information from migrated NONS file, as per Article 25(3) request; permission to refer is granted by ECHA.

 

Results

LD50 = 4028 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 028 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The complete read across justification is detailed in section 13. Test substance is an isomer of the substance under registration; structural difference is not expected to significantly impact the acute toxicity potential. Source study has reliability 2: only limited information available from a migrated NONS file, as per Article 25(3) request.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

No information on the method is available

GLP compliance:

yes

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

not specified

Clinical signs:

other:

Route of administration: percutaneous.

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 > 2000 mg/kg bw.

Executive summary:

Method

Test conducted according to OECD guideline 402. No details on method are available. Information from migrated NONS file, as per Article 25(3) request; permission to refer is granted by ECHA.

 

Results

LD50 > 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

No data on acute toxicity of Direct Blue 273 was available, thus a read across approach was followed. In particular, available information on Similar Substance 01, i.e. an isomer of Direct Blue 273, was used in the assessment.

Based on the structural similarity, the read across approach was considered as appropriate; further details are included in section 13.

Information on the Similar Substance 01 derived from migrated NONS file with permission to refer granted by ECHA. Details on testing method, animals and procedures are lacking.

 

Acute toxicity: oral

A test was conducted according to OECD guideline 401. Using Similar Substance 01, an LD50 of 4028 mg/kg bw was found.

Acute toxicity: dermal

A test was conducted according to OECD guideline 402. Similar Substance 01 showed an LD50 higher than 2000 mg/kg bw for acute dermal toxicity.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

 

The oral LD50 value was established to be higher than 2000 mg/kg bw, therefore the test substance above the classification threshold for acute oral toxicity (oral acute toxicity Category 4: 300 < ATE ≤ 2000 mg/kg bw).

 

The dermal LD50 value was established to be higher than 2000 mg/kg bw, which exceeded the CLP limit for classification (dermal acute toxicity Category 4: 1000 < ATE ≤ 2000 mg/kg bw).

 

In conclusion, test substance is not classified for oral and dermal acute toxicity under the CLP Regulation. Based on a read across approach, a classification for acute toxicity does not apply to Direct Blue 273.