Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
221.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
DNEL value:
5 527.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
Accounts for the correction for difference in absorption between routes (rat -inhalation to human - inhalation), the difference in the standard respiratory volume and the differences between the experimental and human exposure conditions
AF for dose response relationship:
1
Justification:
dose descriptor is a NOAEL
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
rat - systemic effect (inhalation route)
AF for other interspecies differences:
2.5
Justification:
systemic effect
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
Justification:
good quality
AF for remaining uncertainties:
1
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
31.35 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
DNEL value:
3 135 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Accounts for the correction for difference in absorption between routes (rat -inhalation to human - dermal), the difference in the standard respiratory volume and the differences between the experimental and human exposure conditions
AF for dose response relationship:
1
Justification:
dose descriptor is a NOAEL
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat - systemic effect (dermal route)
AF for other interspecies differences:
2.5
Justification:
systemic effect
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
Justification:
good quality
AF for remaining uncertainties:
1
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

As production stream 4 is not classified for acute toxicity, acute DNEL values do not have to be calculated according to the REACH "Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health". As it is not classified for local effects (inhalation), no DNEL value had to be derived either.

As no information on dose-response for eye irritation and skin irritation is available, no DNEL was derived for these endpoints; however, a qualitative approach to assessing and controlling the risks was followed.

For long-term effects, the toxicity to reproduction study is not yet available (proposed in IUCLID section 7.8) and hence, a DNEL value could not yet be derived. However, additional, interim risk management measures were defined for this endpoint in accordance with the ECHA Factsheet of 15/09/2009.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
39.28 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
DNEL value:
1 964.3 mg/m³
Explanation for the modification of the dose descriptor starting point:
Accounts for the correction for difference in absorption between routes (rat -inhalation to human - inhalation), the difference in the standard respiratory volume, the differences between the experimental and human exposure conditions
AF for dose response relationship:
1
Justification:
dose descriptor is a NOAEL
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
rat - systemic effect (inhalation route)
AF for other interspecies differences:
2.5
Justification:
systemic effect
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
good quality
AF for remaining uncertainties:
1
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.26 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
DNEL value:
2 651.78 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Accounts for the correction for difference in absorption between routes (rat -inhalation to human - dermal), the difference in the standard respiratory volume and the differences between the experimental and human exposure conditions
AF for dose response relationship:
1
Justification:
dose descriptor is a NOAEL
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat - systemic effect (dermal route)
AF for other interspecies differences:
2.5
Justification:
systemic effect
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
good quality
AF for remaining uncertainties:
1
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.26 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
DNEL value:
2 651.78 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Accounts for the correction for difference in absorption between routes (rat -inhalation to human - oral), the difference in the standard respiratory volume and the differences between the experimental and human exposure conditions
AF for dose response relationship:
1
Justification:
dose descriptor is a NOAEL
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat - systemic effect (oral route)
AF for other interspecies differences:
2.5
Justification:
systemic effect
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
good quality
AF for remaining uncertainties:
1
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

See discussion for workers.