Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

11.67 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):

30

Modified dose descriptor starting point:

NOAEC

Value:

350 mg/m³

Explanation for the modification of the dose descriptor starting point:

Due to vapour pressure and particle size distribution, inhalable / respirable particles are negligible. Any nuisance dust ingested will remain in the mouth/nose with the potential for subsequent oral exposure. Hence NOAEL for oral toxicity is considered the appropriate endpoint for hazard assessment. Therefore oral absorption in rat is assumed to be 100% and inhalation absorption in humans is assumed to be 100%. Corrected NOAEC (inhalation) = NOAEL (oral rat) / AS * BW(human) / Hrv. Allometric scaling factor: 4; BW (human) = 70 kg Hrv = Human respiration rate = 10 m3 / person. Therefore, corrected NOAEC (inhalation) = 350 mg/m³ (200/4 * 70/10)

AF for dose response relationship:

1

Justification:

Default assessment factor when the starting point for the DNEL calculation is a NOAEC

AF for differences in duration of exposure:

6

Justification:

Default assessment factor for extrapolation from subacute to chronic - for worst case

AF for interspecies differences (allometric scaling):

1

Justification:

Allometric scaling done at route to route extrapolation step in accordance with left hand side of Example R. 8-2 of Appendix R. 8-2, part 1.

AF for other interspecies differences:

1

Justification:

Allometric scaling factor considered sufficient to account for interspecies differences when calculated from human NOAEC

AF for intraspecies differences:

5

Justification:

Default assessment factor of 5 for workers

AF for the quality of the whole database:

1

Justification:

GLP study conducted in accordance with OECD Guideline.

AF for remaining uncertainties:

1

Justification:

No remaining uncertainties

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

1 750 mg/m³

Most sensitive endpoint:

acute toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

5

Modified dose descriptor starting point:

NOAEC

Value:

8 750 mg/m³

Explanation for the modification of the dose descriptor starting point:

Due to vapour pressure, dedusting and particle size distribution, inhalable / respirable particles are negligible. Any nuisance dust ingested will remain in the mouth/nose with the potential for subsequent oral exposure. Hence NOAEL for acute oral toxicity is considered the appropriate endpoint for hazard assessment. Therefore, oral absorption in rats is assumed to be 100% and inhalation absorption in rats is assumed to be 100%. Allometric scaling factor: 4 BW(human) = 70 kg, Hrv = Human respiration rate = 10 m3 / person. Corrected NOAEC (inhalation) = NOAEL (oral rat) / AS * BW(human) / Hrv. = 5000 / 4 * 70/10 = 8750 mg/m3. For workers (in case of 8 hour exposure / day).

AF for dose response relationship:

1

Justification:

Default assessment factor when the starting point for the DNEL calculation is a NOAEC

AF for interspecies differences (allometric scaling):

1

Justification:

Allometric scaling done at route to route extrapolation step in accordance with left hand side of Example R. 8-2 of Appendix R. 8-2, part 1.

AF for other interspecies differences:

1

Justification:

Allometric scaling factor considered sufficient to account for interspecies differences when calculated from human NOAEC

AF for intraspecies differences:

5

Justification:

Default assessment factor of 5 for workers

AF for the quality of the whole database:

1

Justification:

GLP study conducted equivalent or similar to OECD Guideline.

AF for remaining uncertainties:

1

Justification:

No remaining uncertainties

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown (no further information necessary)

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown (no further information necessary)

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Acute/short term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

Acute/short term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified

Additional information - workers

The test substance does not have any local irritating effects in animals. There are no inhalation data available for the substance. However, the test substance showed contact sensitizing properties, whereas the hydrolysis product did not cause sensitizing effects.

Hence, calculation of local or dermal DNELS on the basis of the available data does not seem to be reasonable.

Due to its skin sensitizing effects, dermal exposure of the test substance has to be avoided and respective risk measures like local exhausion and/or dermal protection have to be applied.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

2.92 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):

60

Modified dose descriptor starting point:

NOAEC

Value:

175 mg/m³

Explanation for the modification of the dose descriptor starting point:

Due to vapour pressure and particle size distribution, inhalable / respirable particles are negligible. Any nuisance dust ingested will remain in the mouth/nose with the potential for subsequent oral exposure. Therefore, 100% oral absorption in rats is assumed and 100% inhalation absorption in humnas is assumed. Corrected NOAEC (inhalation) = NOAEL (oral rat) / AS * BW(human) / Hrv. Allometric scaling factor: 4; BW (human) = 70 kg Hrv = Human respiration rate = 20 m3 / person. Therefore, corrected NOAEC (inhalation) = 175 mg/m3 (200/4 * 70/20)

AF for dose response relationship:

1

Justification:

Default assessment factor when the starting point for the DNEL calculation is a NOAEL

AF for differences in duration of exposure:

6

Justification:

Default assessment factor for extrapolation from subacute to chronic - for worst case

AF for interspecies differences (allometric scaling):

1

Justification:

Allometric scaling done at route to route extrapolation step in accordance with left hand side of Example R. 8-2 of Appendix R. 8-2, part 1.

AF for other interspecies differences:

1

Justification:

Allometric scaling factor considered sufficient to account for interspecies differences

AF for intraspecies differences:

10

Justification:

Default assessment factor of 10 for general population

AF for the quality of the whole database:

1

Justification:

GLP study conducted in accordance with OECD Guideline

AF for remaining uncertainties:

1

Justification:

No remaining uncertainties

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

218.75 mg/m³

Most sensitive endpoint:

acute toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

20

Modified dose descriptor starting point:

NOAEC

Value:

4 375 mg/m³

Explanation for the modification of the dose descriptor starting point:

Due to vapour pressure and particle size distribution, inhalable / respirable particles are negligible. Any nuisance dust ingested will remain in the mouth/nose with the potential for subsequent oral exposure. Hence NOAEL for acute oral toxicity is considered the appropriate endpoint for hazard assessment. Therefore oral absorption in rats is assumed to be 100% and inhalation absorption in rats is assumed to be 100%. Allometric scaling factor: 4 BW(human) = 70 kg, Hrv = Human respiration rate = 20 m3 / person. Corrected NOAEC (inhalation) = NOAEL (oral rat) / AS * BW(human) / Hrv. = 5000 / 4 * 70/20 = 4375 mg/m3.

AF for dose response relationship:

1

Justification:

Default assessment factor when the starting point for the DNEL calculation is a NOAEC

AF for interspecies differences (allometric scaling):

1

Justification:

Allometric scaling done at route to route extrapolation step in accordance with left hand side of Example R. 8-2 of Appendix R. 8-2, part 1.

AF for other interspecies differences:

1

Justification:

Allometric scaling factor considered sufficient to account for interspecies differences

AF for intraspecies differences:

10

Justification:

Default assessment factor of 10 for general population

AF for the quality of the whole database:

2

Justification:

non-GLP study conducted equivalent or similar to OECD Guideline

AF for remaining uncertainties:

1

Justification:

No remaining uncertainties

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown (no further information necessary)

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown (no further information necessary)

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Acute/short term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

Acute/short term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.83 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):

240

Modified dose descriptor starting point:

NOAEL

Value:

200 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation not required

AF for dose response relationship:

1

Justification:

Default assessment factor when the starting point for the DNEL calculation is a NOAEL

AF for differences in duration of exposure:

6

Justification:

Default assessment factor for extrapolation from subacute to chronic - for worst case

AF for interspecies differences (allometric scaling):

4

Justification:

Allometric scaling factor for rat compared with humans is 4

AF for other interspecies differences:

1

Justification:

Allometric scaling factor considered sufficient to account for interspecies differences

AF for intraspecies differences:

10

Justification:

Default assessment factor for the general population

AF for the quality of the whole database:

1

Justification:

GLP study conducted in accordance with OECD Guideline.

AF for remaining uncertainties:

1

Justification:

No remaining uncertainties

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

62.5 mg/kg bw/day

Most sensitive endpoint:

acute toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

80

Modified dose descriptor starting point:

NOAEL

Value:

5 000 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation not required

AF for dose response relationship:

1

Justification:

Default assessment factor when the starting point for the DNEL calculation is a NOAEL

AF for interspecies differences (allometric scaling):

4

Justification:

Allometric scaling factor for rat compared with humans is 4

AF for other interspecies differences:

1

Justification:

Allometric scaling factor considered sufficient to account for interspecies differences

AF for intraspecies differences:

10

Justification:

Default assessment factor for the general population

AF for the quality of the whole database:

2

Justification:

non-GLP study conducted equivalent or similar to OECD Guideline

AF for remaining uncertainties:

1

Justification:

No remaining uncertainties

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified

Additional information - General Population

The test substance does not have any local irritating effects in animals. There are no inhalation data available for the substance. However, the test substance showed contact sensitizing properties, whereas the hydrolysis product did not cause sensitizing effects.

Hence, calculation of local or dermal DNELs on the basis of the available data does not seem to be reasonable.

Due to the chemical reaction of the dye with the cotton during the dyeing process, the test substance is covalently bound to the textile. It is therefore unlikely that the consumer is exposed to the dye from contact to the dyed textile. For home-dyeing, consumer use is restricted to dyeing with the washing machine (closed system). The preparation provided for home-dyeing is designed in a way that exposure of the consumer to the powder can be excluded. A consumer exposure to the test substance can therefore be omitted.