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Registration Dossier
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EC number: 201-304-8 | CAS number: 80-73-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.23 mg/m³
- Most sensitive endpoint:
- effect on fertility
- 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:
- 20 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 17.62 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral NOAELrat × (1/0.38 m^3/kg bw) × (6.7 m^3/10m^3) × (50% /100%) = 20 × 2.63 × 0.67 × 0.5
Inhalation NOAEChuman = 17.62 mg/m^3
- AF for dose response relationship:
- 1
- Justification:
- A NOAEC for systemic toxicity was derived
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable as inhalation DNEL
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Complete data set for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.7 mg/m³
DNEL related information
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 17.62 mg/m³
- Explanation for the modification of the dose descriptor starting point:
DNEL derivation method: ECHA REACH Guidance
3x the long-term DNEL = 0.7 mg/m3
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:
- 0.03 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Dermal NOELrat× (50% / 50%) = 10 × 1
Dermal NOELhuman= 10 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is a NOEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Complete data set for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
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:
- high hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.06 mg/m³
- Most sensitive endpoint:
- effect on fertility
- 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:
- 20 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 8.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral NOAELrat × (1/1.15 m^3/kg bw) × (50% /100%) = 20 × 0.869 × 0.5
Inhalation NOAEChuman = 8.7 mg/m^3
- AF for dose response relationship:
- 1
- Justification:
- A NOAEC for systemic toxicity was derived
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable as inhalation DNEL
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 10
- Justification:
- Default value for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Complete data set for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.2 mg/m³
DNEL related information
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.06 mg/m³
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:
- 0.017 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Dermal NOELrat× (50% / 50%) = 10 × 1
Dermal NOELhuman= 10 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- A NOAEL was derived
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor for the rat
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 10
- Justification:
- Default value for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Complete data set for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
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:
- 0.03 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:
- 20 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 20 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral NOAELrat × (50% / 50%) = 20
Oral NOAELhuman = 20 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor for the rat
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 10
- Justification:
- Default value for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Complete data set for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.09 mg/kg bw/day
DNEL related information
- DNEL extrapolated from long term DNEL
- Explanation for the modification of the dose descriptor starting point:
DNEL derivation method: ECHA REACH Guidance
3x the long-term DNEL =0.09 mg/m^3
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
In an in vivo eye irritation study in rabbits, the substance caused serious eye damage and was classified as category 1 for eye effects. Therefore the substance is considered a medium hazard. No information on which to derive a threshold or minimal effect level is available.
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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