Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.11 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
Modified dose descriptor starting point:
NOAEC
DNEL value:
52.9 mg/m³
Explanation for the modification of the dose descriptor starting point:
Worker Population - NOAEL of 30 mg/kg/d / 0.38 m3/kg * [6.7 m3/ 10 m3] = 52.9 mg/m3.
AF for dose response relationship:
1
Justification:
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
AF for differences in duration of exposure:
1
Justification:
For duration adjustment no factor is needed.
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 accounts for additional interspecies differences
AF for intraspecies differences:
5
Justification:
For intraspecies differences the default factor is 5 for workers
AF for the quality of the whole database:
1
Justification:
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgement related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
AF for remaining uncertainties:
2
Justification:
read-across approach
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.3 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
Modified dose descriptor starting point:
NOAEL
DNEL value:
30 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal risk assessment is based on the oral NOAEL of 30 mg/kg/day from a chronic toxicity test. The worst case (100% absorption) was assumed.
AF for dose response relationship:
1
Justification:
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
AF for differences in duration of exposure:
1
Justification:
For duration adjustment no factor is needed.
AF for interspecies differences (allometric scaling):
4
Justification:
The allometric scaling factor for the rat
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 accounts for additional interspecies differences
AF for intraspecies differences:
5
Justification:
For intraspecies differences the default factor is 5 for workers
AF for the quality of the whole database:
1
Justification:
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgement related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable
AF for remaining uncertainties:
2
Justification:
Read-across approach
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
19.75 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor:
other: LOAEL
AF for interspecies differences (allometric scaling):
10
Justification:
AF for interspecies differences (allometric scaling): 10
AF for intraspecies differences:
5
Justification:
AF for intraspecies differences: 5
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
19.75 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
other: LOAEL
AF for interspecies differences (allometric scaling):
10
Justification:
AF for interspecies differences (allometric scaling): 10
AF for intraspecies differences:
5
Justification:
AF for intraspecies differences: 5

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:
DNEL (Derived No Effect Level)
Value:
0.5 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
Modified dose descriptor starting point:
NOAEC
DNEL value:
25.9 mg/m³
Explanation for the modification of the dose descriptor starting point:
General Population - NOAEL of 30 mg/kg/d / 1.16 m3/kg = 25.9 mg/m3
AF for dose response relationship:
1
Justification:
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
AF for differences in duration of exposure:
1
Justification:
For duration adjustment no factor is needed.
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 accounts for additional interspecies differences
AF for intraspecies differences:
10
Justification:
For intraspecies differences the default factor is 10 for consumers
AF for the quality of the whole database:
1
Justification:
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgement related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
AF for remaining uncertainties:
2
Justification:
Read-across approach
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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):
200
Modified dose descriptor starting point:
NOAEL
DNEL value:
30 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal risk assessment is based on the oral NOAEL of 30 mg/kg/day from a chronic toxicity test. The worst case (100% absorption) was assumed.
AF for dose response relationship:
1
Justification:
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
AF for differences in duration of exposure:
1
Justification:
For duration adjustment no factor is needed.
AF for interspecies differences (allometric scaling):
4
Justification:
The allometric scaling factor for the rat
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 accounts for additional interspecies differences
AF for intraspecies differences:
10
Justification:
For intraspecies differences the default factor is 10 for consumers
AF for the quality of the whole database:
1
Justification:
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgement related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
AF for remaining uncertainties:
2
Justification:
read-across approach
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.87 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor:
other: LOAEL
AF for dose response relationship:
1
AF for differences in duration of exposure:
1
AF for interspecies differences (allometric scaling):
10
AF for other interspecies differences:
1
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.87 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
other: LOAEL
AF for dose response relationship:
1
AF for interspecies differences (allometric scaling):
10
AF for other interspecies differences:
1
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1

General Population - Hazard via oral 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):
200
Modified dose descriptor starting point:
NOAEL
DNEL value:
30 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The starting point is NOAEL of 30 mg/kg/day from a chronic toxicity rat study.
AF for dose response relationship:
1
Justification:
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
AF for differences in duration of exposure:
1
Justification:
For duration adjustment no factor is needed.
AF for interspecies differences (allometric scaling):
4
Justification:
The allometric scaling factor for the rat
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 accounts for additional interspecies differences
AF for intraspecies differences:
10
Justification:
For intraspecies differences the default factor is 10 for consumers
AF for the quality of the whole database:
1
Justification:
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgement related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
AF for remaining uncertainties:
2
Justification:
read-across approach
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 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
DNEL value:
100 mg/kg bw/day
AF for interspecies differences (allometric scaling):
4
Justification:
The allometric scaling factor for the rat
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 accounts for additional interspecies differences
AF for intraspecies differences:
10
Justification:
For intraspecies differences the default factor is 10 for consumers

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population