Registration Dossier
Registration Dossier
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EC number: 700-208-8 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.29 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 247 mg/m³
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling factor needs to be applied for the human inhalation route.
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 222 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Value:
- 66 640 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
LD50 dermal rat is > 2000 mg/kg
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:
- 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:
- 0.58 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:
- 100 mg/kg bw/day
- Value:
- 87 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is devoid of any practical relevant systemic toxicity after short-term expsoure ( LD50 in rat: >2000 mg/kg bw). All relevant effects are covered by the long-term DNEL.
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 72.5 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- 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:
- 100 mg/kg bw/day
- Value:
- 43 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
corrected dermal NOAEL = (ABSoral rat/ABSderm.rat) * (ABSderm.rat/ABSderm.human)*correction forDifferences experimental and human exposure conditions*oral NOAEL
corrected dermal NOAEL = (100%/100%)*(100%/0.21%)*1.0*100mg/kg bw = 47619.05 mg/kg bw
DNEL = corrected NOAEL/overall AF = 47619.05/600 = 79.4 mg/kg bw
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
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:
- 0.167 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- 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:
- 100 mg/kg bw/day
- Value:
- 100 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low 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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