Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.29 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:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
246.7 mg/m³
Explanation for the modification of the dose descriptor starting point:

Figure R.8-3 of ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (Version 2.1; November 2012).

AF for dose response relationship:
1
Justification:
Default assessment factor applied because starting point for DNEL calculation is a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on administration of test material to the rat for six weeks (subacute to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not required because differences in breathing between rat and human already accounted for during modification of starting point
AF for other interspecies differences:
2.5
Justification:
Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
AF for intraspecies differences:
5
Justification:
Default assessment factor for workers
AF for the quality of the whole database:
1
Justification:
The starting point NOAEL was obtained from a GLP guideline study
AF for remaining uncertainties:
1
Justification:
No other assessment factor is considered necessary
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:
4.7 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:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Example B.5 of ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (Version 2.1; November 2012)

AF for dose response relationship:
1
Justification:
Default assessment factor applied because starting point for DNEL calculation is a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on administration of test material to the rat for six weeks (subacute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling to correct for differences in metabolic rate (rat to human)
AF for other interspecies differences:
2.5
Justification:
Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
AF for intraspecies differences:
5
Justification:
Default assessment factor for workers
AF for the quality of the whole database:
1
Justification:
The starting point NOAEL was obtained from a GLP guideline study
AF for remaining uncertainties:
1
Justification:
No other assessment factor is considered necessary
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:
medium hazard (no threshold derived)

Additional information - workers

The substance is not acutely toxic via the oral or dermal routes (LD50 > 2000 mg/kg), has a low vapour pressure at ambient temperature and no evidence of skin sensitisation has been reported. It is therefore considered that risk management measures applied in the industrial and professional setting to guard against irritant effects of the material will prevent substantial exposure of humans. Nevertheless, long-term systemic DNELs have been derived for the respiratory and dermal routes as a precaution.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.58 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):
150
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
86.96 mg/m³
Explanation for the modification of the dose descriptor starting point:

Figure R.8-3 of ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (Version 2.1; November 2012)

AF for dose response relationship:
1
Justification:
Default assessment factor applied because starting point for DNEL calculation is a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on administration of test material to the rat for six weeks (subacute to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not required because differences in breathing between rat and human already accounted for during modification of starting point
AF for other interspecies differences:
2.5
Justification:
Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
AF for intraspecies differences:
10
Justification:
Default assessment factor for general population
AF for the quality of the whole database:
1
Justification:
The starting point NOAEL was obtained from a GLP guideline study
AF for remaining uncertainties:
1
Justification:
No other assessment factor is considered necessary
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:
1.67 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):
600
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Example B.5 of ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (Version 2.1; November 2012)

AF for dose response relationship:
1
Justification:
Default assessment factor applied because starting point for DNEL calculation is a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on administration of test material to the rat for six weeks (subacute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling to correct for differences in metabolic rate (rat to human)
AF for other interspecies differences:
2.5
Justification:
Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
AF for intraspecies differences:
10
Justification:
Default assessment factor for general population
AF for the quality of the whole database:
1
Justification:
The starting point NOAEL was obtained from a GLP guideline study
AF for remaining uncertainties:
1
Justification:
No other assessment factor is considered necessary
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:
0.33 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):
600
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation not required

AF for dose response relationship:
1
Justification:
Default assessment factor applied because starting point for DNEL calculation is a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on administration of test material to the rat for six weeks (subacute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling to correct for differences in metabolic rate (rat to human)
AF for other interspecies differences:
2.5
Justification:
Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
AF for intraspecies differences:
10
Justification:
Default assessment factor for general population
AF for the quality of the whole database:
1
Justification:
The starting point NOAEL was obtained from a GLP guideline study
AF for remaining uncertainties:
1
Justification:
No other assessment factor is considered necessary
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

The substance is not acutely toxic via the oral or dermal routes (LD50 > 2000 mg/kg), has a low vapour pressure at ambient temperature and no evidence of skin sensitisation has been reported. It is therefore considered that reduced substance concentration in formulations handled by the general public, combined with suitable label instructions, will guard against irritant effects of the material and prevent substantial exposure of humans. Nevertheless, long-term systemic DNELs have been derived for the respiratory and dermal routes as a precaution.