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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
