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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 289-056-7 | CAS number: 85959-61-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.47 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 110 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalatory NOAEC = Oral NOAEL x (1/0.38 m3/kg/d) x 0.67 x (ABSoral/ABSinh)
Inhalatory NOAEC = 125 x (1/0.38) x 0.5 x 0.67 = 110.2 mg/kg/d
110.2/75 = 1.47 mg/k/d
- AF for dose response relationship:
- 1
- Justification:
- NOAEL used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Inhalation DNEL therefore not applicable
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaing interspecies species
- AF for intraspecies differences:
- 5
- Justification:
- Default value systemic effects workers
- AF for the quality of the whole database:
- 1
- Justification:
- Guideline study available so no additional assessment factor has been considered.
- AF for remaining uncertainties:
- 1
- Justification:
- No additional factors to consider.
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:
- 0.417 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal NOAEC = oral NOAEL x (ABSoral/ABSdermal)
Dermal NOAEC = 125 x 1 = 125
125/300 = 0.417 mg/kg/d
- AF for dose response relationship:
- 1
- Justification:
- NOAEL used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Study conducted on rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaing interspecies species
- AF for intraspecies differences:
- 5
- Justification:
- Default value systemic effects workers
- AF for the quality of the whole database:
- 1
- Justification:
- Guideline study available so no additional assessment factor has been considered.
- AF for remaining uncertainties:
- 1
- Justification:
- No additional factors to consider.
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:
- 0.36 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:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 54 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalation NOAEC = Oral NOAEL x (1/1.5 m3/kg/d) x (ABSoral/ABSinhal)
Inhalation NOAEC = 125 x(1/1.15) x 0.5 = 54 mg/ m3
54/150 = 0.36 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- NOAEL used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Inhalation DNEL therefore not applicable
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaing interspecies species
- AF for intraspecies differences:
- 10
- Justification:
- Default value systemic effects general population
- AF for the quality of the whole database:
- 1
- Justification:
- Guideline study available so no additional assessment factor has been considered.
- AF for remaining uncertainties:
- 1
- Justification:
- No additional factors to consider
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:
- 0.208 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:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal NOAEC = Oral NOAEL x (ABSoral/ABSdermal)
Dermal NOAEC = 125 x 1 = 125
125/600 = 0.208 mg/kg/d
- AF for dose response relationship:
- 1
- Justification:
- Starting point of NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling for rat
- AF for other interspecies differences:
- 2.5
- Justification:
- remaing interspecies differences default value
- AF for intraspecies differences:
- 10
- Justification:
- default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- OECD guidelines and GLP followed
- 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:
- 0.208 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:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAEL =125 mg/kg/d
Assessment factor = 600
125/600 = 0.208 mg/kg/d
- AF for dose response relationship:
- 1
- Justification:
- NOEAL starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic default value
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for remaing differences
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- OECD guideline done to GLP
- 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.
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