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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
375
Dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 763.16 mg/m³
AF for dose response relationship:
1
Justification:
Default value (ECHA)
AF for differences in duration of exposure:
3
Justification:
Default value (ECHA) for subacute to subchronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable for inhalation.
AF for other interspecies differences:
2.5
Justification:
An assessment factor of 2.5 is suggested by the ECHA guidance document (version 2.1, November 2012) for remaining interspecies differences, but justified deviations are possible.
AF for intraspecies differences:
5
Justification:
An assessment factor of 5 is suggested by the ECHA guidance document (version 2.1, November 2012) for intraspecies differences in workers, but justified deviations are possible.
AF for the quality of the whole database:
1
Justification:
A GLP guideline study is used.
AF for remaining uncertainties:
10
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.11 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
125
Dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 763.16 mg/m³
AF for dose response relationship:
1
Justification:
Default value (ECHA)
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
Justification:
An assessment factor of 2.5 is suggested by the ECHA guidance document (version 2.1, November 2012) for remaining interspecies differences, but justified deviations are possible.
AF for intraspecies differences:
5
Justification:
An assessment factor of 5 is suggested by the ECHA guidance document (version 2.1, November 2012) for intraspecies differences in workers, but justified deviations are possible.
AF for the quality of the whole database:
1
Justification:
A GLP guideline study is used.
AF for remaining uncertainties:
10

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.75 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor:
NOAEC
Value:
1 763.16 mg/m³
AF for dose response relationship:
1
Justification:
Default value (ECHA)
AF for differences in duration of exposure:
3
Justification:
Default value (ECHA) for subacute to subchronic exposure
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
1
AF for intraspecies differences:
5
Justification:
An assessment factor of 5 is suggested by the ECHA guidance document (version 2.1, November 2012) for intraspecies differences in workers, but justified deviations are possible.
AF for the quality of the whole database:
1
Justification:
A GLP guideline study is used.
AF for remaining uncertainties:
10
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35.26 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEC
Value:
1 763.16
AF for dose response relationship:
1
Justification:
Default value (ECHA)
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
1
AF for intraspecies differences:
5
Justification:
An assessment factor of 5 is suggested by the ECHA guidance document (version 2.1, November 2012) for intraspecies differences in workers, but justified deviations are possible.
AF for the quality of the whole database:
1
Justification:
A GLP guideline study is used.
AF for remaining uncertainties:
10

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.33 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 500
Dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default value (ECHA)
AF for differences in duration of exposure:
3
Justification:
Default value (ECHA) for subacute to subchronic exposure
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
Justification:
An assessment factor of 2.5 is suggested by the ECHA guidance document (version 2.1, November 2012) for remaining interspecies differences, but justified deviations are possible.
AF for intraspecies differences:
5
Justification:
An assessment factor of 5 is suggested by the ECHA guidance document (version 2.1, November 2012) for intraspecies differences in workers, but justified deviations are possible.
AF for the quality of the whole database:
1
Justification:
A GLP guideline study is used.
AF for remaining uncertainties:
10
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
500
Dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default value (ECHA)
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
Justification:
An assessment factor of 2.5 is suggested by the ECHA guidance document (version 2.1, November 2012) for remaining interspecies differences, but justified deviations are possible.
AF for intraspecies differences:
5
Justification:
An assessment factor of 5 is suggested by the ECHA guidance document (version 2.1, November 2012) for intraspecies differences in workers, but justified deviations are possible.
AF for the quality of the whole database:
1
Justification:
A GLP guideline study is used.
AF for remaining uncertainties:
10

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
AF for dose response relationship:
1
Justification:
Default value (ECHA)
AF for differences in duration of exposure:
3
Justification:
Default value (ECHA) for subacute to subchronic exposure
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
1
AF for intraspecies differences:
5
Justification:
An assessment factor of 5 is suggested by the ECHA guidance document (version 2.1, November 2012) for intraspecies differences in workers, but justified deviations are possible.
AF for the quality of the whole database:
1
Justification:
A GLP guideline study is used.
AF for remaining uncertainties:
10
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
AF for dose response relationship:
1
Justification:
Default value (ECHA)
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
1
AF for intraspecies differences:
5
Justification:
An assessment factor of 5 is suggested by the ECHA guidance document (version 2.1, November 2012) for intraspecies differences in workers, but justified deviations are possible.
AF for the quality of the whole database:
1
Justification:
A GLP guideline study is used.
AF for remaining uncertainties:
10

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:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population