Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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
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
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
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
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.