Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.053 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
Modified dose descriptor starting point:
NOAEC
Value:
528.95 mg/m³
Explanation for the modification of the dose descriptor starting point:

In the absence of repeated dose inhalation toxicity data, the NOAEL from the 28 day repeated dose oral toxicity study in rat (300 mg/kg bw/day) can be taken as a starting point for deriving a DNELlong-term, workers, inhalation. The value must first be corrected for route differences as described in REACH guidance document R.8 version 2.1, November 2012  (‘Characterisation of dose (concentration)-response for human health’) to obtain a corrected inhlation NOAEC: Inhalation NOAEC corr = (NOAEL oral/vSRrat) X (vSR human / vWSRhuman) x ABSoral/ABSinh = (300 / 0.38) x (6.7/10) x (50/50) = 528.9474 mg/m3 Based on the toxicokinetics assessment ABSoral=50% and ABSinhalation=50%.  

AF for dose response relationship:
1
Justification:
Dose-response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Exposure duration (sub-acute to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Not for inhalation
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
Intraspecies variation (workers)
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 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
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

In the absence of repeated dose dermal toxicity data, the NOAEL from the 28 day repeated dose oral toxicity study in rat (300 mg/kg bw/day) can be taken as a starting point for deriving a DNEL long-term, workers, dermal.  In a first step, the oral value should be corrected for route-to-route extrapolation. In accordance with REACH Guidance document R8 (v2.1, November 2012) the dermal NOAEL is calculated according to: Dermal N(L)OAEL=oral (N(L)OAEL x ( ABSoral/ABSdermal). Based on the toxicokinetics assessment ABSoral=50% and ABSdermal=50%.  

AF for dose response relationship:
1
Justification:
Dose-response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Exposure duration (sub-acute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Interspecies difference (rat-to-human)
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
Intraspecies variation (workers)
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The derivation of DNELs-Workers has taken into account the ECHA CSA Guidance part E, how the substance is used and the toxicological properties available for the substance.

This substance is manufactured and used in powder form or dissolved (mixture).

The substance is manufactured in closed systems and is used in industrial sites to dye paper, textile and leather items at low concentration.

The finished items are available to consumers (general population).

For this substance non-treshold effects have not been identified.

The substance is not classified as hazardous for human health neither by acute toxicity nor repeated dose toxicity.

The substance is not classified as skin irritant, corrosive or sensitising.

The substance is not classified as eye irritant or corrosive.

The starting point to derive DNELs is an available NOAEL (oral route-rat) from a <90 days study with value 300 mg/kg bw/day. Following the Practical Guide 14 and the ECHA Guidance R.8 this NOAEL has been corrected to a more suitable dose descriptor starting point to derive DNELs.

The Assessment Factors taken are the ones as described in REACH ECHA Guidance.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 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
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

In the absence of repeated dose dermal toxicity data, the NOAEL from the 28 day repeated dose oral toxicity study in rat (300 mg/kg bw/day) can be taken as a starting point for deriving a DNEL long-term, workers, dermal.  In a first step, the oral value should be corrected for route-to-route extrapolation. In accordance with REACH Guidance document R8 (v2.1, November 2012) the dermal NOAEL is calculated according to: Dermal N(L)OAEL=oral (N(L)OAEL x ( ABSoral/ABSdermal). Based on the toxicokinetics assessment ABSoral=50% and ABSdermal=50%.  

AF for dose response relationship:
1
Justification:
Dose-response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Exposure duration (sub-acute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Interspecies difference (rat-to-human)
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
Intraspecies variation (population)
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
0.5 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
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

There is no route-to-route extrapolation.

AF for dose response relationship:
1
Justification:
Dose-response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Exposure duration (sub-acute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Interspecies difference (rat-to-human)
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
Intraspecies variation (population)
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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

Additional information - General Population

The derivation of DNELs-Population has taken into account the ECHA CSA Guidance part E, how the substance may reach the consumers and the toxicological properties available for the substance.

This substance is a dye to colour paper, textile and leather items. The amount of substance used in these substrates is usually 0.1 -5%.

The substance is chemically bound to the substrate (paper, textile or leather) with no release as powder, mist or vapour.

The finished items are available to consumers (general population).

For this substance non-threshold effects have not been identified.

The substance is not classified as hazardous for human health neither by acute toxicity nor repeated dose toxicity.

The substance is not classified as irritant, corrosive or sensitising.

The starting point to derive DNELs is an available NOAEL (oral route-rat) from a <90 days study with value 300 mg/kg bw/day. Following the Practical Guide 14 and the ECHA Guidance R.8 this NOAEL has been corrected to a more suitable dose descriptor starting point to derive DNELs.

The Assessment Factors taken are the ones as described in REACH ECHA Guidance.