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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.18 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):
25
Dose descriptor starting point:
other: LOAEL mg/kg
Value:
7 mg/kg bw/day
Modified dose descriptor starting point:
other: Corrected LOAEL (mg/m3)
Value:
4.56 mg/m³
Explanation for the modification of the dose descriptor starting point:

See "Explanation for hazard conclusion" below

AF for dose response relationship:
2
Justification:
Effects noted in NTP study are considered to be minor. LOAEL to NOAEC
AF for differences in duration of exposure:
1
Justification:
UK MSA indicated that “No factor is needed for study duration”. Study duration sufficient for long term systemic effects
AF for interspecies differences (allometric scaling):
1
Justification:
not applicable - Table R. 8-4 When to apply allometric scaling (AS) factor in step c
AF for other interspecies differences:
2.5
Justification:
Table R. 8-6 Default assessment factors. Chapter R.8: Characterisation of dose [concentration]-response for human health; Pg 32.
AF for intraspecies differences:
5
Justification:
Default ECHA guidance for Worker population
AF for the quality of the whole database:
1
Justification:
ECHA guidance default
AF for remaining uncertainties:
1
Justification:
Chronic studies are available in rats and mice; most sensitive species used for point of departure
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
other: Not derived.

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:
0.41 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):
175
Dose descriptor starting point:
LOAEL
Value:
7 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
51.395 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

See "Explanation for hazard conclusion" below

AF for dose response relationship:
2
Justification:
Effects noted in NTP study are considered to be minor. LOAEL to NOAEL
AF for differences in duration of exposure:
1
Justification:
UK MSA indicated that “No factor is needed for study duration”. Study duration sufficient for long term systemic effects
AF for interspecies differences (allometric scaling):
7
Justification:
Table R. 8-3 Allometric scaling factors for different species as compared to humans - mouse
AF for other interspecies differences:
2.5
Justification:
Table R. 8-6 Default assessment factors. Chapter R.8: Characterisation of dose [concentration]-response for human health; Pg 32.
AF for intraspecies differences:
5
Justification:
intraspecies – workers
AF for the quality of the whole database:
1
Justification:
quality of database
AF for remaining uncertainties:
1
Justification:
Chronic studies are available in rats and mice; most sensitive species used for point of departure
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
other: not derived

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
other: Not derived

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.03 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):
50
Dose descriptor starting point:
other: LOAEL mg/kg
Value:
7 ng/m³
Modified dose descriptor starting point:
LOAEC
Value:
1.63 mg/m³
Explanation for the modification of the dose descriptor starting point:

See "Explanation for hazard conclusion" below

AF for dose response relationship:
2
Justification:
Effects noted in NTP study are considered to be minor. LOAEL to NOAEL
AF for differences in duration of exposure:
1
Justification:
UK MSA indicated that “No factor is needed for study duration”. Study duration sufficient for long term systemic effects
AF for interspecies differences (allometric scaling):
1
Justification:
not applicable - Table R. 8-4 When to apply allometric scaling (AS) factor in step c. Covered in corrected LOAEL derivation
AF for other interspecies differences:
2.5
Justification:
Table R. 8-6 Default assessment factors. Chapter R.8: Characterisation of dose [concentration]-response for human health; Pg 32.
AF for intraspecies differences:
10
Justification:
Default ECHA guidance for Consumer population
AF for the quality of the whole database:
1
Justification:
Quality of the database
AF for remaining uncertainties:
1
Justification:
Chronic studies are available in rats and mice; most sensitive species used for point of departure
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
other: not derived

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:
DNEL (Derived No Effect Level)
Value:
0.15 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):
350
Dose descriptor starting point:
LOAEL
Value:
7 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
51.395 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

See "Explanation for hazard conclusion" below

AF for dose response relationship:
2
Justification:
Effects noted in NTP study are considered to be minor. LOAEL to NOAEL
AF for differences in duration of exposure:
1
Justification:
UK MSA indicated that “No factor is needed for study duration”. Study duration sufficient for long term systemic effects
AF for interspecies differences (allometric scaling):
7
Justification:
Table R. 8-3 Allometric scaling factors for different species as compared to humans - mouse
AF for other interspecies differences:
2.5
Justification:
Table R. 8-6 Default assessment factors. Chapter R.8: Characterisation of dose [concentration]-response for human health; Pg 32.
AF for intraspecies differences:
10
Justification:
Default ECHA guidance for Consumer population
AF for the quality of the whole database:
1
Justification:
quality of the database
AF for remaining uncertainties:
1
Justification:
Chronic studies are available in rats and mice; most sensitive species used for point of departure
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:
DNEL (Derived No Effect Level)
Value:
0.02 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):
350
Dose descriptor starting point:
LOAEL
Value:
7 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

See "Explanation for hazard conclusion" below

AF for dose response relationship:
2
Justification:
Effects noted in NTP study are considered to be minor. LOAEL to NOAEL
AF for differences in duration of exposure:
1
Justification:
UK MSA indicated that “No factor is needed for study duration”. Study duration sufficient for long term systemic effects
AF for interspecies differences (allometric scaling):
7
Justification:
Table R. 8-3 Allometric scaling factors for different species as compared to humans. Mouse is given as 7
AF for other interspecies differences:
2.5
Justification:
Table R. 8-6 Default assessment factors. Chapter R.8: Characterisation of dose [concentration]-response for human health; Pg 32.
AF for intraspecies differences:
10
Justification:
Default ECHA guidance for Consumer population
AF for the quality of the whole database:
1
Justification:
quality of database
AF for remaining uncertainties:
1
Justification:
Chronic studies are available in rats and mice; most sensitive species used for point of departure
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

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