Registration Dossier
Registration Dossier
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EC number: 947-037-7 | 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:
- 2.16 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA Reach guidance; the NOAEL was corrected by a factor of 1,77 (=1/0,566) as the registered substance contains only 56,6 % of active and the dose in the repeated dose toxicity study was calculated for the active alone.
- Overall assessment factor (AF):
- 72
- Dose descriptor starting point:
- other: NOAEL, corrected for active content of 56.6 %
- Value:
- 177 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 156 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEC(corrected, inhal) = [NOAEL(Rat oral) * respiratoy volume (human)] / [respiratoy volume rat)* AF (inhal rat =2x) * respiratoy volume (human = 10m³ (in 8h))
=NOAEL(oral) * 6,7m³ / 0,38 m³ * 2 * 10 m³ for Workers
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 6
- Justification:
- default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECETOC Technical Report 110 recomendation; ECETOC 2010
- AF for other interspecies differences:
- 1
- Justification:
- included in allometric scaling; ECETOC Technical Report 110 recomendation; ECETOC 2010
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC Technical Report 110 recomendation; ECETOC 2010
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.16 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 72
- Dose descriptor:
- NOAEC
- Value:
- 88.16 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 6
- Justification:
- default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECETOC Technical Report 110 recomendation; ECETOC 2010
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC Technical Report 110 recomendation; ECETOC 2010
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC Technical Report 110 recomendation; ECETOC 2010
- AF for the quality of the whole database:
- 1
- Justification:
- deafult Reach Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- deafult Reach Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low 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
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
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