Registration Dossier
Registration Dossier
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EC number: 947-523-9 | CAS number: -
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:
- 10.6 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 265 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Assuming by default 100% absorption for the inhalation and 50% absorption for oral exposure routes, and standard respiratory volumes of 0.38 m3/kg over 8 hours for rats, 6.7 m3/person over 8 hours and 10 m3/person over 24 hours for human
- AF for dose response relationship:
- 1
- Justification:
- Default based on ECHA guidance document
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value according to ECHA Guidance document
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already taken into consideration during allometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance and route specific information on toxicokinetic and toxicodynamic is available for animals and human
- AF for intraspecies differences:
- 5
- Justification:
- Default value according to ECHA guidance document
- AF for the quality of the whole database:
- 1
- Justification:
- Database is of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 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:
- 3 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default value based on ECHA guidance document
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value based on ECHA guidance document
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rats to human based on ECHA guidance document
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
- AF for intraspecies differences:
- 5
- Justification:
- Default value according to ECHA Guidance document for rat to human extrapolation
- AF for the quality of the whole database:
- 1
- Justification:
- Database is of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 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:
- 2.6 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 130 mg/m³
- Explanation for the modification of the dose descriptor starting point:
300*1/1.15*0.5
- AF for dose response relationship:
- 1
- Justification:
- Default value according to ECHA Guidance document
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value according to ECHA Guidance Document
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already taken into consideration during allometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance and route specific information on toxicokinetics and toxicodynamics is available for animals and humans
- AF for intraspecies differences:
- 10
- Justification:
- Default factor according to ECHA Guidance document
- AF for the quality of the whole database:
- 1
- Justification:
- High quality database
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 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:
- 1.5 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default factor in ECHA Guidance Document
- AF for differences in duration of exposure:
- 2
- Justification:
- Default factor in ECHA Guidance Document
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor in ECHA Guidance document
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor according to ECHA Guidance document
- AF for intraspecies differences:
- 10
- Justification:
- Default factor according to ECHA Guidance document
- AF for the quality of the whole database:
- 1
- Justification:
- High Quality database
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default factor according to ECHA Guidance document
- AF for differences in duration of exposure:
- 2
- Justification:
- Default factor according to ECHA Guidance document
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor according to ECHA Guidance document
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor according to ECHA Guidance document
- AF for intraspecies differences:
- 4
- Justification:
- Default factor according to ECHA Guidance document
- AF for the quality of the whole database:
- 1
- Justification:
- High quality database
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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.
