Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.75 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):
37.5
Dose descriptor starting point:
LOAEL
DNEL value:
500 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
DNEL value:
440.79 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
352.63 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
other: LD50 cut-off value
DNEL value:
5 000 mg/kg bw/day
Modified dose descriptor starting point:
other: LD50
DNEL value:
4 407.89 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
29.39 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Dose descriptor:
LOAEC
DNEL value:
440.79 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
881.58 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor starting point:
other: LD50 cut-off value
DNEL value:
4 407.89 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 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):
150
Dose descriptor starting point:
LOAEL
DNEL value:
500 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
DNEL value:
500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 mg/kg bw/day
Most sensitive endpoint:
acute 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: LD50 cut-off
DNEL value:
5 000 mg/kg bw/day
Modified dose descriptor starting point:
other: LD50 cut-off
DNEL value:
5 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.33 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Dose descriptor:
LOAEC
DNEL value:
500 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
250 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor starting point:
other: LD50 cut-off
DNEL value:
5 000 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Classified as irritating to eye according to the criteria of directive 67/548/EEC and category 2B according to CLP regulation (EC) n°1272/2008.

All effects were slight to moderate and was fully reversible within a few days.

Concentration for general (consumer) population, the concentration will be below 1%, therefore no hazard is associated for general use levels based on the in vivo eye irritation data.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.9 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:
LOAEC
DNEL value:
500 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
DNEL value:
217.39 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
86.96 mg/m³
Most sensitive endpoint:
acute 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: LD50 cut-off
DNEL value:
5 000 mg/kg bw/day
Modified dose descriptor starting point:
other: LD50 cut-off
DNEL value:
2 173.91 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.25 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Dose descriptor:
LOAEC
DNEL value:
217.39 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
217.39 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
other: LD50 cut-off
DNEL value:
2 173.91 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.67 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):
300
Dose descriptor starting point:
LOAEL
DNEL value:
500 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
DNEL value:
500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
other: LD50 cut-off
DNEL value:
5 000 mg/kg bw/day
Modified dose descriptor starting point:
other: LD50 cut-off
DNEL value:
5 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.17 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Dose descriptor:
LOAEC
DNEL value:
500 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
125 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor starting point:
other: LD50 cut-off
DNEL value:
5 000 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.67 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):
300
Dose descriptor starting point:
LOAEL
DNEL value:
500 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
DNEL value:
500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 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:
other: LD50 cut-off
DNEL value:
5 000 mg/kg bw/day
Modified dose descriptor starting point:
other: LD50 cut-off
DNEL value:
5 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

Classified as irritating to eye according to the criteria of directive 67/548/EEC and category 2B according to CLP regulation (EC) n°1272/2008.

All effects were slight to moderate and was fully reversible within a few days.

Concentration for general (consumer) population, the concentration will be below 1%, therefore no hazard is associated for general use levels based on the in vivo eye irritation data.