Registration Dossier

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