Registration Dossier
Registration Dossier
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EC number: 939-707-2 | 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:
- 0.549 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 41.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEC corr = inhalatory NOAEC * (6h per day / 8h per day) * (6.7 m3 (8h) /10m3 (8h)) (cf. ECHA guidance R8.4.2). => NOAEC corr = 82 * (6/8) * (6.7/10) = 41.2 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- NOAEC used a starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute (OECD 412 study) to chronic duration extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling used in derivation of inhalation DNEL
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Standard factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.36 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 225
- Dose descriptor:
- LOAEC
- AF for dose response relationship:
- 3
- Justification:
- LOAEC used a starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute (OECD 412 study) to chronic duration extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling used in derivation of inhalation DNEL
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Standard factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
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:
- 1.057 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:
- 317.05 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- In the absence of data on absorption via the dermal route, a default factor of 1 is applied as recommended by ECHA R8 guidance (dermal absorption is assumed not to be higher than oral absorption).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute (equivalent to OECD 407 study) to chronic duration extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard factor for rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Standard factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium 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:
- 0.137 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 20.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEC corr = inhalatory NOAEC*(6h perday /24 h per day) (cf. ECHA guidance R8.4.2). => NOAEC corr = 82 * (6/24) = 20.5 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- NOAEC used a starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute (OECD 412 study) to chronic duration extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling used in derivation of inhalation DNEL
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Standard factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.18 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 450
- Dose descriptor:
- LOAEC
- AF for dose response relationship:
- 3
- Justification:
- LOAEC used a starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute (OECD 412 study) to chronic duration extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling used in derivation of inhalation DNEL
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Standard factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
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:
- 0.528 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:
- 317.05 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- In the absence of data on absorption via the dermal route, a default factor of 1 is applied as recommended by ECHA R8 guidance (dermal absorption is assumed not to be higher than oral absorption).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute (equivalent to OECD 407 study) to chronic duration extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard factor for rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Standard factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 0.528 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:
- 317.05 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No modification of the dose descriptor is needed since it was determined in an oral toxicity study.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute (equivalent to OECD 407 study) to chronic duration extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard factor for rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Standard factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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