Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10.6 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
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
265 mg/m³
Explanation for the modification of the dose descriptor starting point:

Assuming by default 100% absorption for the inhalation and 50% absorption for oral exposure routes, and standard respiratory volumes of 0.38 m3/kg over 8 hours for rats, 6.7 m3/person over 8 hours and 10 m3/person over 24 hours for human

AF for dose response relationship:
1
Justification:
Default based on ECHA guidance document
AF for differences in duration of exposure:
2
Justification:
Default value according to ECHA Guidance document
AF for interspecies differences (allometric scaling):
1
Justification:
Already taken into consideration during allometric scaling
AF for other interspecies differences:
2.5
Justification:
No substance and route specific information on toxicokinetic and toxicodynamic is available for animals and human
AF for intraspecies differences:
5
Justification:
Default value according to ECHA guidance document
AF for the quality of the whole database:
1
Justification:
Database is of high quality
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
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
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default value based on ECHA guidance document
AF for differences in duration of exposure:
2
Justification:
Default value based on ECHA guidance document
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for rats to human based on ECHA guidance document
AF for other interspecies differences:
2.5
Justification:
No substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
AF for intraspecies differences:
5
Justification:
Default value according to ECHA Guidance document for rat to human extrapolation
AF for the quality of the whole database:
1
Justification:
Database is of high quality
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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

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:
DNEL (Derived No Effect Level)
Value:
2.6 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
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
130 mg/m³
Explanation for the modification of the dose descriptor starting point:

300*1/1.15*0.5

AF for dose response relationship:
1
Justification:
Default value according to ECHA Guidance document
AF for differences in duration of exposure:
2
Justification:
Default value according to ECHA Guidance Document
AF for interspecies differences (allometric scaling):
1
Justification:
Already taken into consideration during allometric scaling
AF for other interspecies differences:
2.5
Justification:
No substance and route specific information on toxicokinetics and toxicodynamics is available for animals and humans
AF for intraspecies differences:
10
Justification:
Default factor according to ECHA Guidance document
AF for the quality of the whole database:
1
Justification:
High quality database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
DNEL (Derived No Effect Level)
Value:
1.5 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
Value:
300 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default factor in ECHA Guidance Document
AF for differences in duration of exposure:
2
Justification:
Default factor in ECHA Guidance Document
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor in ECHA Guidance document
AF for other interspecies differences:
2.5
Justification:
Default factor according to ECHA Guidance document
AF for intraspecies differences:
10
Justification:
Default factor according to ECHA Guidance document
AF for the quality of the whole database:
1
Justification:
High Quality database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.5 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
Value:
300 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default factor according to ECHA Guidance document
AF for differences in duration of exposure:
2
Justification:
Default factor according to ECHA Guidance document
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor according to ECHA Guidance document
AF for other interspecies differences:
2.5
Justification:
Default factor according to ECHA Guidance document
AF for intraspecies differences:
4
Justification:
Default factor according to ECHA Guidance document
AF for the quality of the whole database:
1
Justification:
High quality database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population