Registration Dossier
Registration Dossier
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EC number: 232-391-0 | CAS number: 8013-07-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 70 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEC
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:
- 1.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
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
Oral DNEL:
The relevant endpoint is the NOAEL of 1000 mg/kg bw/d from the repeat dose oral rat study; no treatment-related adverse effects were seen.
The following assessment factors were used:
- Intraspecies: 4 (rat) and 2.5 (remaining differences).
- Interspecies: 5
- Exposure duration: no additional factor was used for short-term exposure but 6 was used for extrapolation from a sub-acute study to chronic exposure for the long term exposure.
- Dose-response: 1 was used due to low toxicity and no relevant effects seen in the repeat dose study.
- Quality of the data base: 2 was used due to the absence of sufficient data on reproductive or developmental toxicity.
The overall assessment factor of for short-term effects is 100 and for long-term effects is 600.
Dermal DNEL
It is assumed that Dermal absorption = Oral absorption and therefore Dermal DNEL = Oral DNEL.
Inhalation DNEL
Using the Oral DNEL, extrapolation to Inhalation by taking into consideration 70 kg bw and 10 m3/person was carried out.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 1 200
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEC
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:
- 0.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 1 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
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:
- 0.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 1 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Oral DNEL:
The relevant endpoint is the NOAEL of 1000 mg/kg bw/d from the repeat dose oral rat study; no treatment-related adverse effects were seen.
The following assessment factors were used:
- Intraspecies: 4 (rat) and 2.5 (remaining differences).
- Interspecies: 10
- Exposure duration: no additional factor was used for short-term exposure but 6 was used for extrapolation from a sub-acute study to chronic exposure for the long term exposure.
- Dose-response: 1 was used due to low toxicity and no relevant effects seen in the repeat dose study.
- Quality of the data base: 2 was used due to the absence of sufficient data on reproductive or developmental toxicity.
The overall assessment factor of for short-term effects is 200 and for long-term effects is 1200.
· Dermal DNEL
It is assumed that Dermal absorption = Oral absorption and therefore Dermal DNEL = Oral DNEL.
· Inhalation DNEL
Using the Oral DNEL, extrapolation to Inhalation by taking into consideration 70 kg bw and 20 m3/person was carried out.
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