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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

Local effects

Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
16 mg/cm²
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
5
Dose descriptor starting point:
other: NOAEL

Workers - Hazard for the eyes

Additional information - workers

The test substance does not have any local irritating or sensitizing effects in animals. There is no inhalation data available for the substance. By extrapolation it is possible to calculate systemic and local DNELS for short term and some long term exposure; however calculation of long term local DNELS on the basis of the available data does not seem to be reasonable, as the substance is not classified for toxicological effects.

 

Given that exposure considerations for skin and eye exposure in the dyeing industry where the substance is used can be stated as negligible and prevented, it is therefore the consideration of the registrant that quantitative local effects based on animal data cannot be conducted. Instead, qualitative assessments of acute/short term and long term effects have instead be conducted, based on the data available. By extrapolation it is possible to calculate systemic and local DNELS for short term and some long term exposure; however calculation of long term local DNELS for local effects on the basis of the available data does not seem to be reasonable, as the substance is not classified for toxicological effects.

 

Based on existing study data and known application of use by textile manufacturing workers, the operation conditions and risk management measures indicated in the respective chapters of this CSR are appropriate and sufficient for controlling the risks.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.8 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

Local effects

Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8 mg/cm²
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
10
Dose descriptor starting point:
other: 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
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

The test substance does not have any local irritating or sensitizing effects in animals. There is no inhalation data available for the substance. By extrapolation it is possible to calculate systemic and Local DNELS for short term exposure; however calculation of long term DNELS on the basis of the available data does not seem to be reasonable.

Due to the chemical reaction of the dye with the fabric 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. Home-dyeing is not applicable for the use of this substance. A consumer exposure to the test substance can therefore be omitted.

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