Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35.2 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):
25
Dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
881 mg/m³
Explanation for the modification of the dose descriptor starting point:

A repeat dose toxicity study via the inhalation route of exposure is not available. Therefore, the NOAEL from a repeat-dose toxicity study via the oral route was used.

NOAEC = oral NOAEL x (1/0.38m3/kg bw/day)x(abs oral/abs inhal) x 0.67

= 1000 x 2.63 x 0.5 x 0.67

= 881.0

DNEL = PoD/AF

= 881/25

= 35.2 mg/m3

AF for dose response relationship:
1
Justification:
As the dose descriptor is the NOAEL, the default assessment factor is 1.
AF for differences in duration of exposure:
2
Justification:
To account for using PoD taken from a subchronic study to calculate a chronic DNEL.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is usually not applied in the derivation of the inhalation DNEL
AF for other interspecies differences:
2.5
Justification:
Default factor
AF for intraspecies differences:
5
Justification:
To account for intraspecies differences in an occupational setting.
AF for the quality of the whole database:
1
Justification:
The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
AF for remaining uncertainties:
1
Justification:
Not applicable.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35.2 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):
25
Dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
881 mg/m³
Explanation for the modification of the dose descriptor starting point:

A repeat dose toxicity study via the inhalation route of exposure is not available. Therefore, the NOAEL from a repeat-dose toxicity study via the oral route was used.

NOAEC = oral NOAEL x (1/0.38m3/kg bw/day)x(abs oral/abs inhal) x 0.67

= 1000 x 2.63 x 0.5 x 0.67

= 881.0

DNEL = PoD/AF

= 881/25

= 35.2 mg/m3

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A repeat dose toxicity study via the dermal route of exposure is not available. Therefore, the NOAEL from a repeat-dose toxicity study via the oral route was used .

Dermal N(L)OAEC = oral (N(L)OAEL*( ABSoral/ABSdermal)

= 1000 x (1/1)

DNEL = PoD/AF

= 1000/100

= 10 mg/kg bw/day

AF for dose response relationship:
1
Justification:
As the dose descriptor is the NOAEL, the default assessment factor is 1.
AF for differences in duration of exposure:
2
Justification:
To account for using PoD taken from a subchronic study to calculate a chronic DNEL.
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling to account for differences in allometry in using the rat as a test model.
AF for other interspecies differences:
2.5
Justification:
Default factor
AF for intraspecies differences:
5
Justification:
To account for intraspecies differences in an occupational setting.
AF for the quality of the whole database:
1
Justification:
The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
AF for remaining uncertainties:
1
Justification:
Not applicable.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal N(L)OAEC = oral (N(L)OAEL*( ABSoral/ABSdermal)

= 1000 x (1/1)

DNEL = PoD/AF

= 1000/100

= 10 mg/kg bw/day

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
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:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

No hazard conclusion has been identified on the basis that the substance does not enter the public domain.

Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
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:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The substance does not enter the public domain and therefore DNEL values have not been calculated for the general population