Registration Dossier
Registration Dossier
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EC number: 231-102-5 | CAS number: 7439-93-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Calculations based on worst case. Performance of the study was waived according to column 2 of REACH Regulation 1907/2006/EC Annex VIII section 8.6.1 (see section 7.5.2).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL value was initially used for calculations
- AF for differences in duration of exposure:
- 1
- Justification:
- Recommended AF (for chronic exposure) ECHA REACH Guidance document R8, 2012
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable according to ECHA REACH Guidance document R8, 2012
- AF for other interspecies differences:
- 1
- Justification:
- Not applicable, derived from human data
- AF for intraspecies differences:
- 1
- Justification:
- Not applicable, see below in "justification and comments"
- AF for the quality of the whole database:
- 1
- Justification:
- See below in "justification and comments"
- AF for remaining uncertainties:
- 1
- Justification:
- See below in "justification and comments"
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 12 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Calculations based on worst case. Performance of the study was waived according to column 2 of REACH Regulation 1907/2006/EC Annex VIII section 8.6.1 (see section 7.5.2).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL used for calculations
- AF for differences in duration of exposure:
- 1
- Justification:
- Recommended AF (for chronic exposure) ECHA REACH Guidance document R8, 2012
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable, derived from human data
- AF for other interspecies differences:
- 1
- Justification:
- Not applicable, derived from human data
- AF for intraspecies differences:
- 1
- Justification:
- Not applicable, see below in "justification and comments"
- AF for the quality of the whole database:
- 1
- Justification:
- See below in "justification and comments"
- AF for remaining uncertainties:
- 1
- Justification:
- See below in "justification and comments"
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
DNEL derivation for each of the relevant endpoints was based on the most conservative dose descriptors obtained. Assessment factors were assigned accordingly. Thus, the DNELs represent worst-case scenarios.
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
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Calculations based on worst case
- AF for dose response relationship:
- 1
- Justification:
- NOAEL value was initially used for calculations
- AF for differences in duration of exposure:
- 1
- Justification:
- Recommended AF (for chronic exposure) ECHA REACH Guidance document R8, 2012
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable, derived from human data
- AF for other interspecies differences:
- 1
- Justification:
- Not applicable, derived from human data
- AF for intraspecies differences:
- 1
- Justification:
- Not applicable, see below in "justification and comments"
- AF for the quality of the whole database:
- 1
- Justification:
- See below in "justification and comments"
- AF for remaining uncertainties:
- 1
- Justification:
- See below in "justification and comments"
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 12 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Calculations based on worst case. Performance of the study was waived according to column 2 of REACH Regulation 1907/2006/EC Annex VIII section 8.6.1 (see section 7.5.2).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL used for calculations
- AF for differences in duration of exposure:
- 1
- Justification:
- Recommended AF (for chronic exposure) ECHA REACH Guidance document R8, 2012
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable, derived from human data
- AF for other interspecies differences:
- 1
- Justification:
- Not applicable, derived from human data
- AF for intraspecies differences:
- 1
- Justification:
- Not applicable, see below in "justification and comments"
- AF for the quality of the whole database:
- 1
- Justification:
- see below in "justification and comments"
- AF for remaining uncertainties:
- 1
- Justification:
- See below in "justification and comments"
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1.2 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation required
- AF for dose response relationship:
- 1
- Justification:
- NOAEL used for calculations
- AF for differences in duration of exposure:
- 1
- Justification:
- Recommended AF (for chronic exposure) ECHA REACH Guidance document R8, 2012
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable, derived from human data
- AF for other interspecies differences:
- 1
- Justification:
- Not applicable, derived from human data
- AF for intraspecies differences:
- 1
- Justification:
- Not applicable, see below in "justification and comments"
- AF for the quality of the whole database:
- 1
- Justification:
- See below in "justification and comments"
- AF for remaining uncertainties:
- 1
- Justification:
- See below in "justification and comments"
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
DNEL derivation for each of the relevant endpoints was based on the most conservative dose descriptors obtained. Assessment factors were assigned accordingly. Thus, the DNELs represent worst-case scenarios.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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