Registration Dossier
Registration Dossier
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EC number: 700-263-8 | CAS number: 89686-69-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.88 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (Technical Report No. 110, October 2010)
- Overall assessment factor (AF):
- 18
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Corrected inhalatory NOAEC = oral NOAEL (50 mg/kg bw/d) * 1/0.38 m3/kg/d * (ABS oral, rat/ABS inh,human = 100/100) * 6.7 m3/10 m3= 88 mg/m3.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Assuming chronic worker exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Included in the modification of the dose descriptor starting point.
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 3
- Justification:
- Difference in sensitivity among workers
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable study used
- AF for remaining uncertainties:
- 1
- Justification:
- No reaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
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:
- 0.69 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (Technical Report No. 110, October 2010)
- Overall assessment factor (AF):
- 72
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Corrected dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 50 * 100/100 = 50 mg/kg bw
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Assuming chronic worker exposure
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable study used
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- DNEL (Derived No Effect Level)
- Value:
- 4.17 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (Technical Report No. 110, October 2010)
- Overall assessment factor (AF):
- 3
- Dose descriptor starting point:
- other: 12.5 mg/cm2 (NOAEL)
- AF for dose response relationship:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Local effect
- AF for other interspecies differences:
- 1
- Justification:
- No other differences
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low 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:
- 1.45 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (Technical Report No. 110, October 2010)
- Overall assessment factor (AF):
- 30
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 43.55 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Corrected inhalatory NOAEC = oral NOAEL (50 mg/kg bw/d) * 1/1.15 m3/kg/d * (ABS oral, rat/ABS inh,human = 100/100) = 43.5 mg/m3.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Included in the modification of the dose descriptor starting point
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- Justification:
- Difference in sensitivity witin general population
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable study used.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.42 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (Technical Report No. 110, October 2010)
- Overall assessment factor (AF):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Corrected dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 50 * 100/100 = 50 mg/kg bw
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
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:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 mg/cm²
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (Technical Report No. 110, October 2010)
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- other: NOAEL of 12.5 mg/cm2
- AF for dose response relationship:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Local effect
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.42 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (Technical Report No. 110, October 2010)
- Overall assessment factor (AF):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification needed, oral study was used.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 1
- 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:
- 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
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