Registration Dossier
Registration Dossier
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EC number: 203-933-3 | CAS number: 112-07-2
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 133 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 333 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 169 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- other: See justification and comments below
- Overall assessment factor (AF):
- 1.2
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 203 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Based on a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- No factor is used for study length as the data shows that the severity of key haemotoxic effect does not increase from 90 days to lifetime exposure (see information on repeat dose oral NTP studies in chapter 7.5.3 of IUCLID dossier)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human extrapolation.
- AF for other interspecies differences:
- 0.1
- Justification:
- An interspecies toxicodynamic factor is 0.1 is applied based on the much lower sensitivity of humans to haemotoxicity compared to rodents (see section 7.9.3 of IUCLID dossier).
- AF for intraspecies differences:
- 3
- Justification:
- Proposed factor for workers. See detailed justification in document attached to this record.
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 120 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: See justification and comments below
- Overall assessment factor (AF):
- 9
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 1 080 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Assuming 50% absorption the oral NOAEL translates to a dermal NOAEL of 1080mg/kg.
- AF for dose response relationship:
- 3
- Justification:
- Extrapolation from a LOAEL to a NOAEL. Default factor
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Human data
- AF for other interspecies differences:
- 1
- Justification:
- Human data
- AF for intraspecies differences:
- 3
- Justification:
- Proposed factor for workers. See detailed justification in document attached to this record.
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Dose descriptor:
- other: NOAEL
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 80 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 200 mg/m³
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 102 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- other: See justification and comments below
- Overall assessment factor (AF):
- 2
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 203 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Based on a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- No factor is used for study length as the data shows that the severity of key haemotoxic effect does not increase from 90 days to lifetime exposure (see information on repeat dose oral NTP studies in chapter 7.5.3 of IUCLID dossier)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human extrapolation.
- AF for other interspecies differences:
- 0.1
- Justification:
- An interspecies toxicodynamic factor is 0.1 is applied based on the much lower sensitivity of humans to haemotoxicity compared to rodents (see section 7.9.3 of IUCLID dossier).
- AF for intraspecies differences:
- 5
- Justification:
- Proposed factor for general population. See detailed justification in document attached to this record.
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 72 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: See justification and comments below.
- Overall assessment factor (AF):
- 15
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 080 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Assuming 50% absorption the oral NOAEL translates to a dermal NOAEL of 1080mg/kg.
- AF for dose response relationship:
- 3
- Justification:
- Extrapolation from a LOAEL to a NOAEL. Default factor
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Human data
- AF for other interspecies differences:
- 1
- Justification:
- Human data
- AF for intraspecies differences:
- 5
- Justification:
- Proposed factor for general population. See detailed justification in document attached to this record.
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
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:
- 8.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: See justification and comments below
- Overall assessment factor (AF):
- 1.5
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 12.9 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- LOAEL to NOAEL default factor
- AF for differences in duration of exposure:
- 1
- Justification:
- No factor is used for study length as the data shows that the severity of key haemotoxic effect does not increase from 90 days to lifetime exposure (see information on repeat dose oral NTP studies in chapter 7.5.3 of IUCLID dossier)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- LOAEL is a factor derived for humans by PBPK modelling so no additional allometric factor required.
- AF for other interspecies differences:
- 0.1
- Justification:
- An interspecies toxicodynamic factor is 0.1 is applied based on the much lower sensitivity of humans to haemotoxicity compared to rodents (see section 7.9.3 of IUCLID dossier).
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 36 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- other: See justification and comments below.
- Overall assessment factor (AF):
- 15
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 540 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- LOAEL to NOAEL extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Human data
- AF for other interspecies differences:
- 1
- Justification:
- Human data
- AF for intraspecies differences:
- 5
- Justification:
- Proposed factor for general population. See detailed justification in document attached to this record.
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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.
