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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
4.7 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
705.26 mg/m³
Explanation for the modification of the dose descriptor starting point:

= NOAEL *6.7/10/0.38 (see REACH guidance chapter R.8)

AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
see REACH guidance R.8
Justification:
see REACH guidance R.8; included in modified dose descriptor
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
5
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
18.81 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor:
NOAEC
Value:
2 821.04 mg/m³
AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
subacute to chronic; see REACH guidance R.8
AF for interspecies differences (allometric scaling):
1
Justification:
see REACH guidance R.8
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
5
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
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:
0.67 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

= NOAEL (rat) / 4 (allometric scaling); see REACH guidance R.8

AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
subacute to chronic; see REACH guidance R.8
Justification:
included in modified NOAEL (human) (see above); see REACH guidance R.8
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
5
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.67 mg/cm²
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor:
NOAEC
Value:
400 mg/m³
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
subacute to chronic; see REACH guidance R.8
AF for interspecies differences (allometric scaling):
1
Justification:
see REACH guidance R.8
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
5
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
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:
1.16 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
347.83 mg/m³
Explanation for the modification of the dose descriptor starting point:

= NOAEL / 1.15; see REACH guidance R.8

AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
subacute to chronic; see REACH guidance R.8
AF for interspecies differences (allometric scaling):
1
Justification:
already included in modified NOAEC; see REACH guidance R.8
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
10
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.64 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor:
NOAEC
Value:
347.83 mg/m³
AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
see REACH guidance R.8
AF for interspecies differences (allometric scaling):
1
Justification:
see REACH guidance R.8
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
10
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
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:
0.33 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

= NOAEL / 4 (allometric scaling); see REACH guidance R.8

AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
subacute to chronic; see REACH guidance R.8
Justification:
already included in modified NOAEL
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
10
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.33 mg/cm²
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor:
NOAEC
Value:
400 mg/m³
AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
see REACH guidance R.8
AF for interspecies differences (allometric scaling):
1
Justification:
see REACH guidance R.8
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
10
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
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:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 200
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
subactute to chronic; see REACH guidance R.8
AF for interspecies differences (allometric scaling):
4
Justification:
see REACH guidance R.8
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
10
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population