Registration Dossier
Registration Dossier
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EC number: 230-565-0 | CAS number: 7195-44-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14 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
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 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)
Acute/short 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 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: 240 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 60 mg/kg/day, resulting in a corrected NAEC human of 420 mg/m3 .
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 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:
- 1 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:
- 1 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: 240 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 60 mg/kg/day, resulting in a corrected NAEC human of 210 mg/m3.
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