Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 946-565-5 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.75 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Kinetics (metabolism, distribution and excretion) are considered to be similar for oral and inhalation intake in the absence of evidence of the opposite.
Starting point: NOAEL of 1000 mg/kg bw/day in a 28-day repeated dose toxicity study in rat.
Conversion of an oral NOAEL into a corrected NOAEC:
For workers (8h exposure/day), the corrected inhalatory NOAEC = oral NOAEL * 1/sRVrat * ABSoral-rat /ABSinhal-human * sRVhuman/wRV
= 1000 mg/kg bw/day * 1/0.38 m3/kg/8h * ABSoral-rat /ABSinhal-human * 6.7 m3(8h)/10 m3(8h)
= 1000 mg/kg bw/day * 1/0.38 m3/kg/8h * 100/100 * 6.7 m3 (8h)/10 m3(8h)
= 1000/0.38 * 1 * (6.7/10) = 1763 mg/m3.
With ABS: Absorption, sRV: Standard Respiratory Volume; wRV: Worker Respiratory Volume;
ABSoral-rat /ABSinhal-human= 100/100= 1, assuming no differences in inhalation absorption between rats and humans
- AF for dose response relationship:
- 1
- Justification:
- Value is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from subacute study to chronic exposure worker
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No correction for caloric demand for inhalation; is included in dose descriptor starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Difference in sensitivity among workers
- AF for the quality of the whole database:
- 2
- Justification:
- Value based on Read Across
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Kinetics (metabolism, distribution and excretion) are considered to be similar for oral and dermal intake in the absence of evidence of the opposite.Correction dermal NOAEL: 1000 mg/kg bw/dat x 100/100a= 1000 mg/kg bw/day (a% oral/dermal absorption)
- AF for dose response relationship:
- 1
- Justification:
- Value is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from subacute study to chronic exposure worker
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Correction for caloric demand from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Difference in sensitivity among workers
- AF for the quality of the whole database:
- 2
- Justification:
- Value based on Read Across
- 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:
- 2.9 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 870 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Kinetics (metabolism, distribution and excretion) are considered to be similar for oral and inhalation intake in the absence of evidence of the opposite.
For the general population (24h exposure/day), the corrected inhalatory NOAEC = oral NOAEC * 1/sRVrat * ABSoral-rat /ABSinhal-human
= 1000 mg/kg bw/day * 1/1.15 m3/kg * ABSoral-rat /ABSinhal-human
= 1000 * 1/1.15 m3/kg * 1 = 870 mg/m3
With ABS: Absorption, sRV: Standard Respiratory Volume; ABSoral-rat /ABSinhal-human= 100/100= 1, assuming no differences in inhalation absorption between rats and humans.
- AF for dose response relationship:
- 1
- Justification:
- Value is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from subacute study to chronic exposure general population
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No correction for caloric demand for inhalation; is included in dose descriptor starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Difference in sensitivity within general population
- AF for the quality of the whole database:
- 2
- Justification:
- Value based on Read Across
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 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):
- 1 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Kinetics (metabolism, distribution and excretion) are considered to be similar for oral and dermal intake in the absence of evidence of the opposite.Correction dermal NOAEL: 1000 mg/kg bw/day x 100/100a= 1000 mg/kg bw/day (a% oral/dermal absorption).
- AF for dose response relationship:
- 1
- Justification:
- Value is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from subacute study to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Correction for caloric demand from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default vaue for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Difference in sensitivity within general population
- AF for the quality of the whole database:
- 2
- Justification:
- Value based on Read Across
- 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:
- 0.83 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):
- 1 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Value is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from subacute study to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Correction for caloric demand from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default vale for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Difference in sensitivity among general population
- AF for the quality of the whole database:
- 2
- Justification:
- Value based on Read Across
- 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:
- 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.
