Tripotassium [5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-4-sulpho-1-naphthyl)azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

2.939 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

75

Dose descriptor starting point:

NOAEL

Value:

250 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

220.4 mg/m³

AF for dose response relationship:

1

Justification:

based on NOAEL

AF for differences in duration of exposure:

6

Justification:

based on RDT study 28 days

AF for interspecies differences (allometric scaling):

1

Justification:

AF not used for inhalation route - already included in route-to-route extrapolation.

AF for other interspecies differences:

1

Justification:

Due to the properties of the substance, a serious dangerous effect is not expected and the AFs used are sufficient.

AF for intraspecies differences:

5

Justification:

workers

AF for the quality of the whole database:

1

Justification:

Reliability 1

AF for remaining uncertainties:

2.5

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

8.333 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

300

Dose descriptor starting point:

NOAEL

Value:

250 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

2 500 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Kow < -2 and Mw >500 (Mw = 873.83) => 10% absorption

AF for dose response relationship:

1

Justification:

based on NOAEL

AF for differences in duration of exposure:

6

Justification:

based on RDT study 28 days

AF for interspecies differences (allometric scaling):

4

Justification:

based on RDT study on rats

Justification:

Due to the properties of the substance, a serious dangerous effect is not expected and the AFs used are sufficient.

AF for intraspecies differences:

1

Justification:

workers

Justification:

Reliability 1

AF for remaining uncertainties:

2.5

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.725 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

150

Dose descriptor starting point:

NOAEL

Value:

250 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

108.696 mg/m³

AF for dose response relationship:

1

Justification:

based on NOAEL

AF for differences in duration of exposure:

6

Justification:

based on RDT study 28 days

AF for interspecies differences (allometric scaling):

1

Justification:

AF not used for inhalation route - already included in route-to-route extrapolation.

AF for other interspecies differences:

1

Justification:

Due to the properties of the substance, a serious dangerous effect is not expected and the AFs used are sufficient.

AF for intraspecies differences:

10

Justification:

workers

AF for the quality of the whole database:

1

Justification:

Reliability 1

AF for remaining uncertainties:

2.5

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

4.167 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

600

Dose descriptor starting point:

NOAEL

Value:

250 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

2 500 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Kow < -2 and Mw >500 (Mw = 873.83) => 10% absorption

AF for dose response relationship:

1

Justification:

based on NOAEL

AF for differences in duration of exposure:

6

Justification:

based on RDT study 28 days

AF for interspecies differences (allometric scaling):

4

Justification:

based on RDT study on rats

AF for other interspecies differences:

1

Justification:

Due to the properties of the substance, a serious dangerous effect is not expected and the AFs used are sufficient.

AF for intraspecies differences:

10

Justification:

general population

AF for the quality of the whole database:

1

Justification:

Reliability 1

AF for remaining uncertainties:

2.5

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.417 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

600

Dose descriptor starting point:

NOAEL

Value:

250 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

250 mg/kg bw/day

AF for dose response relationship:

1

Justification:

based on NOAEL

AF for differences in duration of exposure:

6

Justification:

based on RDT study 28 days

AF for interspecies differences (allometric scaling):

4

Justification:

based on RDT study on rats

AF for other interspecies differences:

1

Justification:

Due to the properties of the substance, a serious dangerous effect is not expected and the AFs used are sufficient.

AF for intraspecies differences:

10

Justification:

general population

AF for the quality of the whole database:

1

Justification:

Reliability 1

AF for remaining uncertainties:

2.5

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified