Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.3 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):
100
Dose descriptor starting point:
NOAEL
DNEL value:
19 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
335 mg/m³
Explanation for the modification of the dose descriptor starting point:
No study available; DNEL derived from repeated dose toxicity, oral, using ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for dose response relationship:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for differences in duration of exposure:
2
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for interspecies differences (allometric scaling):
4
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for other interspecies differences:
2.5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for intraspecies differences:
5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for the quality of the whole database:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for remaining uncertainties:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.38 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
other: modified LC50
DNEL value:
46 900 mg/m³
Explanation for the modification of the dose descriptor starting point:
no route-to-route justification needed
AF for dose response relationship:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for interspecies differences (allometric scaling):
4
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for other interspecies differences:
2.5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for intraspecies differences:
5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for the quality of the whole database:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for remaining uncertainties:
100
Justification:
AF = 100, According to Guidance on information requirements and chemical safety assessment Chapter R.8, Appendix R.8-8

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.19 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):
100
Dose descriptor starting point:
NOAEL
DNEL value:
19 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
25 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No study available; DNEL derived from repeated dose toxicity, oral, using ECHA Guidance on information requirements and chemical safety assessment R.8 (November 2012, Version 2.1)
AF for dose response relationship:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for differences in duration of exposure:
2
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for interspecies differences (allometric scaling):
4
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for other interspecies differences:
2.5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for intraspecies differences:
5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for the quality of the whole database:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for remaining uncertainties:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

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:
1.65 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):
200
Dose descriptor starting point:
NOAEL
DNEL value:
19 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
335 mg/m³
Explanation for the modification of the dose descriptor starting point:
No study available; DNEL derived from repeated dose toxicity, oral, using ECHA Guidance on information requirements and chemical safety assessment R.8.
AF for dose response relationship:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for differences in duration of exposure:
2
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for interspecies differences (allometric scaling):
4
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for other interspecies differences:
2.5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for intraspecies differences:
10
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for the quality of the whole database:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for remaining uncertainties:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.69 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
other: modified LC50
DNEL value:
46 900 mg/m³
Explanation for the modification of the dose descriptor starting point:
no route-to-route justification needed
AF for dose response relationship:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for interspecies differences (allometric scaling):
4
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for other interspecies differences:
2.5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for intraspecies differences:
10
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for the quality of the whole database:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
Justification:
AF = 100, According to Guidance on information requirements and chemical safety assessment Chapter R.8, Appendix R.8-8

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.125 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):
200
Dose descriptor starting point:
NOAEL
DNEL value:
19 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
25 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No study available; DNEL derived from repeated dose toxicity, oral, using ECHA Guidance on information requirements and chemical safety assessment R.8.
AF for dose response relationship:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for differences in duration of exposure:
2
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for interspecies differences (allometric scaling):
4
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for other interspecies differences:
2.5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for intraspecies differences:
10
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for the quality of the whole database:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for remaining uncertainties:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.125 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.095 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):
200
Dose descriptor starting point:
NOAEL
DNEL value:
19 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
19 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
no route-to-route justification needed
AF for dose response relationship:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for differences in duration of exposure:
2
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for interspecies differences (allometric scaling):
4
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for other interspecies differences:
2.5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for intraspecies differences:
10
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for the quality of the whole database:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
AF for remaining uncertainties:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, ECHA, 2012).
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population