Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.65 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
700 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEC

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.04 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEL

Workers - Hazard for the eyes

Additional information - workers

Corrosive and irritant effects of substances on the skin and eye, as well as in the respiratory tract are usually concentration-dependent. The substance is only classified as a severe eye irritant based on the potential to cause staining (although severe effects do not occur, staining of the eye will occur with exposure). DNELs specifically for irritation/corrosion can only be derived if dose-response information is available, but there are no data available to assess this endpoint. It is not considered appropriate to assess this hazard type by further testing on animals, given that exposure considerations for eye exposure in the dyeing industry where the substance is used can be stated as negligible and preventable. It is therefore the consideration of the registrant that quantitative local effects based on animal data cannot be conducted on the basis of irritation alone. Qualitative assessments of acute/short term and long term effects have instead been conducted based on the data available.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.91 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
350 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.52 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
240
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.26 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
240
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

Corrosive and irritant effects of substances on the skin and eye, as well as in the respiratory tract are usually concentration-dependent. The substance is only classified as a severe eye irritant based on the potential to cause staining (although severe effects do not occur, staining of the eye will occur with exposure). DNELs specifically for irritation/corrosion can only be derived if dose-response information is available, but there are no data available to assess this endpoint. It is not considered appropriate to assess this hazard type by further testing on animals, given that exposure considerations for skin and eye exposure in the dyeing industry where the substance is used can be stated as negligibleand preventable. It is therefore the consideration of the registrant that quantitative local effects based on animal data cannot be conducted on the basis of irritation alone. Qualitative assessments of acute/short term and long term effects have instead been conducted, based on the data available.

 

It should also be noted that due to the chemical reaction of the dye with the cotton / fabric during the dyeing process, the 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) as per the recommended instructions and given that the substance may stain the skin. The preparation provided for home-dyeing is designed in a way that exposure of the consumer to the powder can be excluded.