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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 473-730-4 | CAS number: 928768-73-4
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:
- 3.35 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 125.25 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- long term 28 day repeated dose toxicity is chosen
- AF for dose response relationship:
- 1
- Justification:
- not a LOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- 28 day subacute to chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- there is no need for the species-specific allometric scaling factor for inhalation exposures (ECHA, 2012, table R.8-4)
- AF for other interspecies differences:
- 2.5
- Justification:
- remainder
- AF for intraspecies differences:
- 5
- Justification:
- individual variability
- AF for the quality of the whole database:
- 1
- Justification:
- full data set
- AF for remaining uncertainties:
- 1
- Justification:
- no others
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.05 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):
- 0.33
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3.35 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- long term 28 day repeated dose toxicity is chosen
- AF for remaining uncertainties:
- 0.3
- Justification:
- long term to short term, see justification and comments
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.33 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- long term 28 day repeated dose study is chosen
- AF for dose response relationship:
- 1
- Justification:
- not a LOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- 28 day subchronic study to chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remainder
- AF for intraspecies differences:
- 5
- Justification:
- individual variability in response
- AF for the quality of the whole database:
- 1
- Justification:
- full data set
- AF for remaining uncertainties:
- 1
- Justification:
- no others
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
see attached Hazard Assessment for Dynol 360 Derived No-Effect Levels (DNELs)
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):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 435 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- long term 28 day repeated dose toxicity is chosen
- AF for dose response relationship:
- 1
- Justification:
- not a LOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- 28 day subacute to chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- there is no need for the species-specific allometric scaling factor for ihnalation exposure
- AF for other interspecies differences:
- 2.5
- Justification:
- remainder
- AF for intraspecies differences:
- 10
- Justification:
- individual varability in response
- AF for the quality of the whole database:
- 1
- Justification:
- full data set
- AF for remaining uncertainties:
- 1
- Justification:
- no other
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
General Population - 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- long term 28 day repeated dose toxicity is chosen
- AF for dose response relationship:
- 1
- Justification:
- not a LOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- 28 day subacute to chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remainder
- AF for intraspecies differences:
- 10
- Justification:
- individual varability in response
- AF for the quality of the whole database:
- 1
- Justification:
- full data set
- AF for remaining uncertainties:
- 1
- Justification:
- no other
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
General Population - Hazard via oral 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- long term 28 day repeated dose toxicity is chosen
- AF for dose response relationship:
- 1
- Justification:
- not a LOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- 28 day subacute study to chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remainder
- AF for intraspecies differences:
- 10
- Justification:
- individual variability in response
- AF for the quality of the whole database:
- 1
- Justification:
- full data set
- AF for remaining uncertainties:
- 1
- Justification:
- no other
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 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):
- 0.33
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
- long term 28 day repeated dose toxicity is chosen
- AF for remaining uncertainties:
- 1
- Justification:
- long term to short term, see justification and comments
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
see attached Hazard Assessment for Dynol 360 Derived No-Effect Levels (DNELs)
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