Registration Dossier
Registration Dossier
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EC number: 282-617-7 | CAS number: 84281-74-3
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:
- 1.4 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:
- 105 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NAEC(human worker) = [(NOEL rep oral/allometric factor) x humna default bodyweight]/ human brief capacity(8h)= 218.75 mg/m^3
- AF for dose response relationship:
- 1
- Justification:
- good data about curve dose/response
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NAEC human worker
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- NAEC human worker
- AF for the quality of the whole database:
- 1
- Justification:
- GLP compliant with international guideline
- AF for remaining uncertainties:
- 1
- Justification:
- 100% adsorption for inhalative route for animal and human is assumed
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.2 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:
- 60 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Oral to dermal = 1
- AF for dose response relationship:
- 1
- Justification:
- good data about curve dose/response
- 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:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- human standard to human workers
- AF for the quality of the whole database:
- 1
- Justification:
- Result is based on a good GLP study
- AF for remaining uncertainties:
- 1
- Justification:
- assuming 100% adsorption
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- 0.35 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):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 52.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NAEC(human worker) = [(NOEL rep oral/allometric factor) x humna default bodyweight]/ human brief capacity(24h)= 109.375 mg/m^3
- AF for dose response relationship:
- 1
- Justification:
- good data about curve dose/response
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NAEC human worker
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- NAEC human worker
- AF for the quality of the whole database:
- 1
- Justification:
- GLP compliant with international guideline
- AF for remaining uncertainties:
- 1
- Justification:
- 100% adsorption for inhalative route for animal and human is assumed
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 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:
- 60 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Oral to dermal = 1
- AF for dose response relationship:
- 1
- Justification:
- good data about curve dose/response
- 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:
- 2.5
- Justification:
- remaining differrences
- AF for intraspecies differences:
- 10
- Justification:
- human standard to human general population
- AF for the quality of the whole database:
- 1
- Justification:
- Result is based on a good GLP study
- AF for remaining uncertainties:
- 1
- Justification:
- assuming 100% adsorption
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 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:
- 60 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation
- AF for dose response relationship:
- 1
- Justification:
- good data about curve dose/response
- 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:
- 2.5
- Justification:
- remaining differrences
- AF for intraspecies differences:
- 10
- Justification:
- human standard to human general population
- AF for the quality of the whole database:
- 1
- Justification:
- Result is based on a good GLP study
- AF for remaining uncertainties:
- 1
- Justification:
- assuming 100% adsorption
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
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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