Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
62.4 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):
300
Modified dose descriptor starting point:
NOAEC
Value:
18 725 mg/m³
Explanation for the modification of the dose descriptor starting point:
An inhalation study is nor available because substance has a high melting point and a very low vapour pressure and exposure by inhalation will be negligible.
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Correction for metabolic rate default value
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
700 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):
50
Modified dose descriptor starting point:
NOAEC
Value:
35 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
The substance has a high melting point and a very low vapour pressure and exposure by inhalation will be negligible.
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Correction for metabolic rate default value
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
62.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic exposure default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Correction for metabolic rate default value
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
700 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Correction for metabolic rate default value
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.9 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
Modified dose descriptor starting point:
NOAEL
Value:
2 675 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No long term dermal study available.
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic exposure default value.
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Correction for metabolic rate default value
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
40 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Acute dermal study available
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Correction for metabolic rate default value
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.22 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic exposure default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
1
Justification:
Default 1:1 extrapolation for oral to dermal
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 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: NOAEL
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
1
Justification:
Default 1:1 extrapolation for oral to dermal
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

A single application of the test material to the non-irrigated eye of 6 rabbits produced no corneal opacity or iritis and minimal conjunctival irritation. All treated eyes appeared normal at the 72 -hour observation. The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
31.2 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):
600
Modified dose descriptor starting point:
NOAEC
Value:
18 725 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation study available
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
350 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):
100
Modified dose descriptor starting point:
NOAEC
Value:
35 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
Inhalation study not available
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
31.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
350 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.46 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
2 675 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Very few substances show higher toxicity by dermal contact than oral therefore the oral study was used as the starting point:
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
dermal study available
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.11 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
240
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-chronic to chronic default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
1
Justification:
Default 1:1 extrapolation for oral to dermal
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 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: NOAEL
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value.
AF for other interspecies differences:
1
Justification:
Default 1:1 extrapolation for oral to dermal
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.46 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
2 675 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub acute to chronic default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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
Modified dose descriptor starting point:
NOAEL
Value:
5 000
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population