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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:
8.75 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
DNEL related information

Local effects

Long term exposure
Most sensitive endpoint:
sensitisation (skin)
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:
1.25 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
DNEL related information

Local effects

Long term exposure
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Additional information - workers

According to REACH "Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment", above 10t/y, the establishement of acute toxicity DNEL is unnecessary in most cases, as the DNEL based on long-term exposure is normally sufficient to ensure that adverse effects do not occur. Thus, acute DNELs should default the long-term systemic DNELs.

For local effects, a DNEL was not quantifiable; However, as the substance is known to be a skin sensitizer, local effects must be assessed qualitatively and risk management measures applied as necessary. The potential for respiratory sensitization is unknown; however, given its skin sensitization potential, this endpoint should also be assessed qualitatively.

The dose descriptor starting point for DNEL calculation used:

NOAEL: 150 mg/kg bw/day (determined during a 28-day oral repeated dose toxicity in rats performed in 2011).

By default the dermal absorption was considered to be 100%.

For inhalation, a NAEL human was determined using an allometric scaling of 4 and a body weight of 70 kg and found to be 37.50 mg/kg/day, resulting in a corrected NAEC human of 262.5 mg/m3.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.18 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
DNEL related information

Local effects

Long term exposure
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.62 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
DNEL related information

Local effects

Long term exposure
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
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:
0.62 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
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

According to REACH "Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment", above 10t/y, the establishement of acute toxicity DNEL is unnecessary in mosts cases, as the DNEL based on long-term exposure is normally sufficient to ensure that adverse effects do not occur. Thus, acute DNELs should default the long-term systemic DNELs.

For local effects, a DNEL was not quantifiable; However, as the substance is known to be a skin sensitizer, local effects must be assessed qualitatively and risk management measures applied as necessary. The potential for respiratory sensitization is unknown; however, given its skin sensitization potential, this endpoint should also be assessed qualitatively.

The dose descriptor starting point for DNEL calculation used:

NOAEL: 150 mg/kg bw/day (determined during a 28-day oral repeated dose toxicity in rats performed in 2011).

Oral absorption was considered to be 100% based on experimental data.

By default the dermal absorption was considered to be 100%.

For inhalation, a NAEL human was determined using an allometric scaling of 4 and a body weight of 70 kg and found to be 37.5 mg/kg/day, resulting in a corrected NAEC human of 131.25 mg/m3.

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