Registration Dossier
Registration Dossier
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EC number: 204-877-2 | CAS number: 128-08-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.53 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:
- 45 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 39.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For workers (8h exposure/day), the corrected inhalatoryNOAEC = oral NOAEL * 1/sRVrat * ABSoral-rat /ABSinhal-human * sRVhuman/wRV
= 45 mg/kg bw/day * 1/0.38 m3/kg/8h * ABSoral-rat /ABSinhal-human * 6.7 m3(8h)/10 m3(8h)
= 45 mg/kg bw/day * 1/0.38 m3/kg/8h * 1/2 * 6.7 m3(8h)/10 m3(8h)
= 45 mg/kg bw/day/0.38 * 1/2 * (6.7/10) = 39.7 mg/m3.
With ABS: Absorption, sRV: Standard Respiratory Volume; wRV: Worker Respiratory Volume;
Kinetics (metabolism, distribution and excretion) are considered to be similar for oral and inhalation intake in the absence of evidence of the opposite.
On the assumption that, in general, inhalative absorption might well be higher than oral absorption, a default factor of 1/2 (ABSoral-rat /ABSinhal-human) is considered
- AF for dose response relationship:
- 1
- Justification:
- Value is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation to chronic exposure worker from sub-acute toxicity study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No correction for caloric demand for inhalation; is included in dose descriptor starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- According to ECHA guidance
- AF for intraspecies differences:
- 5
- Justification:
- Difference in sensitivity among workers
- AF for the quality of the whole database:
- 1
- Justification:
- Results based on reliable study with the substance
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- high 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)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.21 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:
- 45 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 63 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation.
An additional correction factor of 7/5 is introduced to account for exposure differences (7 days/week in the rat study vs. 5 days exposure per working week).
- AF for dose response relationship:
- 1
- Justification:
- Value is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation to chronic exposure worker from short-term toxicity study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Correction for caloric demand from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- According to ECHA guidance
- AF for intraspecies differences:
- 5
- Justification:
- Difference in sensitivity among workers
- AF for the quality of the whole database:
- 1
- Justification:
- Results based on reliable study with the substance
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- high 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:
- 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
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
DNEL related information
- Justification:
- Correction for caloric demand from rat to human
- Justification:
- Results based on reliable study on the substance
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
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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