Registration Dossier
Registration Dossier
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EC number: 263-731-6 | CAS number: 62780-89-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.18 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88.16 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 100 mg/kg/day in 28 -day repeated dose toxicity study (oral route, OECD 407; Braun, 2008) was used to derive a DNEL long-term, systemic effects via the inhalation route (most sensitive endpoint/lowest NOAEL). After route-to-route extrapolation from oral to inhalation, the dose descriptor starting point NOAEC is 88.16 mg/m³ = 100 mg/kg/d x 1/0.38 m³/kg/d x 0.67 x 0.5. This correction factor is derived from the inhaled volumes in 8 hours under respective conditions (6.7 m³ for base level, 10m³ for light activity). An additional correction factor of 0.5 is used as it is assumed that the bioavailability after oral exposure is 50% while the bioavailability after inhalation is assumed to be 100%.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- difference in study duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- included in the route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- no need for further assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- no need for further assessment factor
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 100 mg/kg/day established in the 28 -day repeated dose toxicity study (oral route, OECD 407; Braun, 2008) was used to derive a DNEL long-term, systemic effects via dermal administration (most sensitive endpoint/lowest NOAEL). After route-to-route extrapolation (oral to dermal) the dose descriptor starting point is 100 mg/kg/d. No additional correction factor is applied as bioavailability after oral exposure as well as after dermal exposure is assumed to be 50%.
- AF for dose response relationship:
- 1
- Justification:
- starting point NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- difference in duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- no need for further assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- no need for further assessment factor
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 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
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
General Population - Hazard via oral route
Systemic 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 for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
No DNEL is derived for general population as no consumer use is expected.
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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