Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.05 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):
20
Dose descriptor starting point:
NOAEL
Value:
17 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
21 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
According to the ECHA REACH Guidance an assessment factor (AF) of 6 should be used as default value for a subacute study and a factor of 2 for a sub-chronic study. The NOAEL used for hazard assessment was determined from a repeated dose study (combined with reproduction/ developmental toxicity screening test) where the animals were treated continuously for a period of 66 days, which is twice as long as in a subacute study. Thus, an assessment factor of 4 (2x AF of a subacute study) is used to extrapolate from this study duration to a chronic study.
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
1
Justification:
The substance is metabolised via general metabolic pathways that are common among different species and very similar to rodents and humans and the absence of any specific target organs
indicating a specific MOA at high concentrations there is no reason to believe that an additional AF of 2.5 for remaining differences is required.
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
297.5 µg/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):
80
Dose descriptor starting point:
NOAEL
Value:
17 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
23.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
According to the ECHA REACH Guidance an assessment factor (AF) of 6 should be used as default value for a subacute study and a factor of 2 for a sub-chronic study. The NOAEL used for hazard assessment was determined from a repeated dose study (combined with reproduction/ developmental toxicity screening test) where the animals were treated continuously for a period of 66 days, which is twice as long as in a subacute study. Thus, an assessment factor of 4 (2x AF of a subacute study) is used to extrapolate from this study duration to a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
1
Justification:
The substance is metabolised via general metabolic pathways that are common among different species and very similar to rodents and humans and the absence of any specific target organs
indicating a specific MOA at high concentrations there is no reason to believe that an additional AF of 2.5 for remaining differences is required.
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
185 µg/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):
40
Dose descriptor starting point:
NOAEL
Value:
17 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
7.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
According to the ECHA REACH Guidance an assessment factor (AF) of 6 should be used as default value for a subacute study and a factor of 2 for a sub-chronic study. The NOAEL used for hazard assessment was determined from a repeated dose study (combined with reproduction/ developmental toxicity screening test) where the animals were treated continuously for a period of 66 days, which is twice as long as in a subacute study. Thus, an assessment factor of 4 (2x AF of a subacute study) is used to extrapolate from this study duration to a chronic study.
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
1
Justification:
The substance is metabolised via general metabolic pathways that are common among different species and very similar to rodents and humans and the absence of any specific target organs
indicating a specific MOA at high concentrations there is no reason to believe that an additional AF of 2.5 for remaining differences is required.
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
106.25 µg/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):
160
Dose descriptor starting point:
NOAEL
Value:
17 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
17 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
According to the ECHA REACH Guidance an assessment factor (AF) of 6 should be used as default value for a subacute study and a factor of 2 for a sub-chronic study. The NOAEL used for hazard assessment was determined from a repeated dose study (combined with reproduction/ developmental toxicity screening test) where the animals were treated continuously for a period of 66 days, which is twice as long as in a subacute study. Thus, an assessment factor of 4 (2x AF of a subacute study) is used to extrapolate from this study duration to a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
1
Justification:
The substance is metabolised via general metabolic pathways that are common among different species and very similar to rodents and humans and the absence of any specific target organs
indicating a specific MOA at high concentrations there is no reason to believe that an additional AF of 2.5 for remaining differences is required.
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
106.25 µg/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):
160
Dose descriptor starting point:
NOAEL
Value:
17 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
17 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
According to the ECHA REACH Guidance an assessment factor (AF) of 6 should be used as default value for a subacute study and a factor of 2 for a sub-chronic study. The NOAEL used for hazard assessment was determined from a repeated dose study (combined with reproduction/ developmental toxicity screening test) where the animals were treated continuously for a period of 66 days, which is twice as long as in a subacute study. Thus, an assessment factor of 4 (2x AF of a subacute study) is used to extrapolate from this study duration to a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
1
Justification:
The substance is metabolised via general metabolic pathways that are common among different species and very similar to rodents and humans and the absence of any specific target organs
indicating a specific MOA at high concentrations there is no reason to believe that an additional AF of 2.5 for remaining differences is required.
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population