Registration Dossier
Registration Dossier
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EC number: 700-041-0 | 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:
- 3.52 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:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264.47 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Long term exposure – inhalation systemicDose description modification - Guidance [1. Appendix R8-1] was followed for route to route extrapolation as no relevant dose descriptor were available for inhalation exposure. As noted in R.8.4.2, as no information regarding inhalation absorption is available, a worse case scenario that 100% of the dose will be absorbed via the inhalation route. The dose descriptor was modified to take into account an 8 hour exposure and the respiratory volume corrected for light work.
NOAECcorr = NOAEL *1 / rat resp. volume * oral / inhalation absorption * human resting resp. volume / worker resp. volume
NOAECcorr(general) = 150 mg/kg/bw *(1 / 0.38) * (100% (default) / 100%(default)) * 6.7 m3 (8hr) / 10 m3 (8hr) = 264.47 mg/m3
Assessment factors -Default assessment factors [1. R-8.4.3.3.] were applied.
Assessment factor = Interspecies * Intraspecies * Exposure duration * Dose-response * Quality of whole database
Assessment factor (general) = 2.5 * 5 * 6 * 1 * 1 = 75
DNEL derivation - DNEL = NOAELcorr / Assessment factor
DNEL = 264.47 mg/kg bw/day / 75 = 3.52 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- No issues
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chromic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- worker
- AF for the quality of the whole database:
- 1
- Justification:
- No issues
- AF for remaining uncertainties:
- 1
- Justification:
- No issues
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:
- 3.3 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Long term exposure –dermal systemic -
NOAELcorr = NOAEL/Allometric scaling*(ABS oral rat / ABS derm rat) * (ABS derm rat / ABS derm human)
NOAELcorr (general) = 150mg/kg bw/4 * (100% (default) / 15% (default)) * (100% (default) / 100% (default)) = 250mg/kg bw
Assessment factors - Default assessment factors [1. R-8.4.3.3.] were applied.
Assessment factor = Interspecies * Intraspecies * Exposure duration * Dose-response * Quality of whole database
Assessment factor (general) = 2.5 * 5 * 6 * 1 * 1 = 75
DNEL derivation - DNEL = NOAELcorr / Assessment factor
DNEL = 250 mg/kg bw/day / 75 = 3.3 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- No issues
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 6
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining
- AF for intraspecies differences:
- 5
- Justification:
- worker
- AF for the quality of the whole database:
- 1
- Justification:
- no issues
- AF for remaining uncertainties:
- 1
- Justification:
- No issues
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:
- low hazard (no threshold derived)
Additional information - workers
Wear eye protection
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:
- 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:
- 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
The substance is consumed in the manufacture of a pharmaceutical product and the substance is not exposed to the 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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