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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
23.63 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
335 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
295 mg/m³
Explanation for the modification of the dose descriptor starting point:

Exposure via the oral route is considered a more appropriate route of exposure than inhalation as the physical chemical properties such as the physical state (liquid at room temperature and pressure) and vapour pressure indicate that exposure via inhalation is unlikely. Thus, the testing via the oral route was suitable for classification and risk assessment.

AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for differences in duration of exposure:
1
Justification:
no extrapolation from subchronic to subacute duration
AF for interspecies differences (allometric scaling):
1
Justification:
accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure
AF for other interspecies differences:
2.5
Justification:
accounts for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
accounts for extrapolation to human in the worker environment
AF for the quality of the whole database:
1
Justification:
available data are deemed complete and consistent
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties exist
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.63 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
335 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
295 mg/m³
Explanation for the modification of the dose descriptor starting point:

Exposure via the oral route is considered a more appropriate route of exposure than inhalation as the physical chemical properties such as the physical state (liquid at room temperature and pressure) and vapour pressure indicate that exposure via inhalation is unlikely. Thus, the testing via the oral route was suitable for classification and risk assessment.

AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for interspecies differences (allometric scaling):
1
Justification:
accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure
AF for other interspecies differences:
2.5
Justification:
accounts for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
accounts for extrapolation to human in the worker environment
AF for the quality of the whole database:
1
Justification:
available data are deemed complete and consistent
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties exist

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
59.07 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
NOAEC
Value:
295 mg/m³
AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for differences in duration of exposure:
1
Justification:
no extrapolation from subchronic to subacute duration
AF for interspecies differences (allometric scaling):
1
Justification:
accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure
AF for other interspecies differences:
1
Justification:
accounts for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
accounts for extrapolation to human in the worker environment
AF for the quality of the whole database:
1
Justification:
available data are deemed complete and consistent
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties exist
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
59.07 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor starting point:
NOAEC
Value:
295 mg/m³
AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for interspecies differences (allometric scaling):
1
Justification:
accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure
AF for other interspecies differences:
1
Justification:
accounts for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
accounts for extrapolation to human in the worker environment
AF for the quality of the whole database:
1
Justification:
available data are deemed complete and consistent
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties exist

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.7 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):
50
Dose descriptor starting point:
NOAEL
Value:
335 mg/kg bw/day
AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for differences in duration of exposure:
1
Justification:
no extrapolation from subchronic to subacute duration
AF for interspecies differences (allometric scaling):
4
Justification:
accounts for allometric scaling from rat
AF for other interspecies differences:
2.5
Justification:
accounts for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
accounts for extrapolation to human in the worker environment
AF for the quality of the whole database:
1
Justification:
available data are deemed complete and consistent
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties exist
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
160 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):
50
AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for interspecies differences (allometric scaling):
4
Justification:
accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure
AF for other interspecies differences:
2.5
Justification:
accounts for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
accounts for extrapolation to human in the worker environment
AF for the quality of the whole database:
1
Justification:
available data are deemed complete and consistent
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties exist

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
133 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Dose descriptor:
LOAEC
Value:
7 052.63 µg/m³
AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for differences in duration of exposure:
1
Justification:
no extrapolation needed to account for mapping of adverse outcome pathway
AF for interspecies differences (allometric scaling):
4
Justification:
accounting for differences in metabolic rate per body weight from mice
AF for other interspecies differences:
1
Justification:
no need to account for remaining interspecies differences for local effects
AF for intraspecies differences:
5
Justification:
accounts for extrapolation to human in the worker environment
AF for the quality of the whole database:
3
Justification:
accounts for use of LOAEL as starting point for data deemed complete and consistent
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties exist
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
133.33 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Dose descriptor starting point:
LOAEC
Value:
7 052.63 µg/m³
AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for interspecies differences (allometric scaling):
7
Justification:
accounting for differences in metabolic rate per body weight from mice
AF for other interspecies differences:
1
Justification:
no need to account for remaining interspecies differences for local effects
AF for intraspecies differences:
5
Justification:
accounts for extrapolation to human in the worker environment
AF for the quality of the whole database:
3
Justification:
accounts for use of LOAEL as starting point for data deemed complete and consistent
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties exist

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Due to the potential for skin sensitization, workers should wear chemically resistant gloves when handling this material.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.83 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):
25
Dose descriptor starting point:
NOAEL
Value:
335 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
145.65 mg/m³
Explanation for the modification of the dose descriptor starting point:

Exposure via the oral route is considered a more appropriate route of exposure than inhalation as the physical chemical properties such as the physical state (liquid at room temperature and pressure) and vapour pressure indicate that exposure via inhalation is unlikely. Thus, the testing via the oral route was suitable for classification and risk assessment.

AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for differences in duration of exposure:
1
Justification:
no extrapolation from subchronic to subacute duration
AF for interspecies differences (allometric scaling):
1
Justification:
accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure
AF for other interspecies differences:
2.5
Justification:
accounts for remaining interspecies differences
AF for intraspecies differences:
10
Justification:
accounts for extrapolation to the human general population
AF for the quality of the whole database:
1
Justification:
available data are deemed complete and consistent
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties exist
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.83 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):
25
Dose descriptor starting point:
NOAEL
Value:
335 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
145.65 µg/m³
Explanation for the modification of the dose descriptor starting point:

Exposure via the oral route is considered a more appropriate route of exposure than inhalation as the physical chemical properties such as the physical state (liquid at room temperature and pressure) and vapour pressure indicate that exposure via inhalation is unlikely. Thus, the testing via the oral route was suitable for classification and risk assessment.

AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for interspecies differences (allometric scaling):
1
Justification:
accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure
AF for other interspecies differences:
2.5
Justification:
accounts for remaining interspecies differences
AF for intraspecies differences:
10
Justification:
accounts for extrapolation to the human general population
AF for the quality of the whole database:
1
Justification:
available data are deemed complete and consistent
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties exist

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.57 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor:
NOAEC
Value:
145.65 mg/m³
AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for differences in duration of exposure:
1
Justification:
no extrapolation needed from subchronic to subacute
AF for interspecies differences (allometric scaling):
1
Justification:
accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure
AF for other interspecies differences:
1
Justification:
accounts for remaining interspecies differences
AF for intraspecies differences:
10
Justification:
accounts for extrapolation to the human general population
AF for the quality of the whole database:
1
Justification:
available data are deemed complete and consistent
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties exist
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.57 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEC
Value:
145.65 mg/m³
AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for interspecies differences (allometric scaling):
1
Justification:
accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure
AF for other interspecies differences:
1
Justification:
accounts for remaining interspecies differences
AF for intraspecies differences:
10
Justification:
accounts for extrapolation to the general human population
AF for the quality of the whole database:
1
Justification:
available data are deemed complete and consistent
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties exist

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.35 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):
100
Dose descriptor starting point:
NOAEL
Value:
335 mg/kg bw/day
AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for differences in duration of exposure:
1
Justification:
no extrapolation needed from subchronic to subacute duration
AF for interspecies differences (allometric scaling):
4
Justification:
accounts for allometric scaling from rat
AF for other interspecies differences:
2.5
Justification:
accounts for remaining interspecies differences
AF for intraspecies differences:
10
Justification:
accounts for extrapolation to the general human population
AF for the quality of the whole database:
1
Justification:
available data are deemed complete and consistent
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties exist
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:
38.1 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
210
Dose descriptor:
LOAEC
Value:
3 478.26 µg/m³
AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for differences in duration of exposure:
1
Justification:
no extrapolation needed from subchronic to subacute duration
AF for interspecies differences (allometric scaling):
7
Justification:
accounting for differences in metabolic rate per body weight from mice
AF for other interspecies differences:
1
Justification:
no need to account for remaining interspecies differences for local effects
AF for intraspecies differences:
10
Justification:
accounts for extrapolation to the general human population
AF for the quality of the whole database:
1
Justification:
available data are deemed complete and consistent
AF for remaining uncertainties:
3
Justification:
accounts for use of LOAEL as starting point for data deemed complete and consistent
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
38.1 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
210
Dose descriptor starting point:
LOAEC
Value:
3 478.26 µg/m³
AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for interspecies differences (allometric scaling):
7
Justification:
accounting for differences in metabolic rate per body weight from mice
AF for other interspecies differences:
1
Justification:
no need to account for remaining interspecies differences for local effects
AF for intraspecies differences:
10
Justification:
accounts for extrapolation to the general human population
AF for the quality of the whole database:
1
Justification:
available data are deemed complete and consistent
AF for remaining uncertainties:
3
Justification:
accounts for use of LOAEL as starting point for data deemed complete and consistent

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.35 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):
100
Dose descriptor starting point:
NOAEL
Value:
335 mg/kg bw/day
AF for dose response relationship:
1
Justification:
the dose-response relationship is deemed reliable
AF for differences in duration of exposure:
1
Justification:
no extrapolation needed from subchronic to subacute duration
AF for interspecies differences (allometric scaling):
4
Justification:
accounts for allometric scaling from rat
AF for other interspecies differences:
2.5
Justification:
accounts for remaining interspecies differences
AF for intraspecies differences:
10
Justification:
accounts for extrapolation to the human general population
AF for the quality of the whole database:
1
Justification:
available data are deemed complete and consistent
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties exist
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

While use of this material in final product preparations, to which the general population would be exposed, would be below the threshold for induction of skin sensitization, use may exceed the threshold for elicitation of skin sensitization and therefore pre-sensitized individuals may experience adverse reaction.