Registration Dossier
Registration Dossier
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EC number: 700-347-4 | 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:
- 10.56 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Route specific data (inhalation) is not available for the test substance therefore the dose descriptor starting point is from a 28-Day repeat dose oral toxicity study.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- AF based on a 90-Day repeat dose study (sub-chronic) which gave a NOAEL >300 mg/kg bw/day. However the dose descriptor starting point is based on a 28-Day repeat dose oral study (sub-acute) which gave a NOAEL of 300mg/kg bw/day
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route specific data (long term dermal exposure) is not available for the test substance therefore the dose descriptor starting point is based on a 28-Day repeat dose oral toxicity study.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- AF based on a 90-Day repeat dose study (sub-chronic) which gave a NOAEL >300 mg/kg bw/day. However the dose descriptor starting point is based on a 28-Day repeat dose oral study (sub-acute) which gave a NOAEL of 300mg/kg bw/day
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- 2.6 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):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 130 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Route specific data (inhalation) is not available for the test substance therefore the dose descriptor starting point is based on a 28-Day repeat dose oral toxicity study.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- AF based on a 90-Day repeat dose study (sub-chronic) which gave a NOAEL >300 mg/kg bw/day. However the dose descriptor starting point is based on a 28-Day repeat dose oral study (sub-acute) which gave a NOAEL of 300mg/kg bw/day
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route specific data (long term dermal exposure) is not available for the test substance therefore the dose descriptor starting point is based on a 28-Day repeat dose oral toxicity study.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- AF based on a 90-Day repeat dose study (sub-chronic) which gave a NOAEL >300 mg/kg bw/day. However the dose descriptor starting point is based on a 28-Day repeat dose oral study (sub-acute) which gave a NOAEL of 300mg/kg bw/day2*4*2.5*10
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route-to-route extrapolation required
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- AF based on a 90-Day repeat dose study (sub-chronic) which gave a NOAEL >300 mg/kg bw/day. However the dose descriptor starting point is based on a 28-Day repeat dose oral study (sub-acute) which gave a NOAEL of 300mg/kg bw/day
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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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