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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The substance has a low vapour pressure and during use no exposure to aerosols with droplets in the inhalable or respirable range is expected.

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.167 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):
300
Dose descriptor starting point:
LOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A safety factor of 3 has been used to convert the LOAEL from the oral study to a NOAEL

Route to route extrapolation taking into account that dermal absorption is set at 10%, while oral absorption is set at 50% (in view of the systemic effects on liver and kidney seen in the repeated dose study) leads to the NOAEL of 50 mg/kg bw that is taken as starting point for the calculation of the DNEL.

AF for dose response relationship:
1
Justification:
the safety factor for extrapolation from LOAEL to NOAEL has already been included in the starting NOAEL
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
species tested is the rat
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
worker exposure
AF for the quality of the whole database:
1
Justification:
based on guideline study under GLP
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
65.6 mg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
90
Dose descriptor:
other: EC3 --> LOAEL
AF for dose response relationship:
3
Justification:
EC3 is considered to be a LOAEL, default factor to extrapolate LOAEL to NOAEL
AF for differences in duration of exposure:
1
Justification:
not applicable
AF for interspecies differences (allometric scaling):
1
Justification:
not applicable
AF for other interspecies differences:
10
Justification:
default
AF for intraspecies differences:
1
Justification:
default
AF for the quality of the whole database:
1
AF for remaining uncertainties:
3
Justification:
effects of the matrix
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

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:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.083 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):
600
Dose descriptor starting point:
LOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A safety factor of 3 has been used to convert the LOAEL from the oral study to a NOAEL

Route to route extrapolation taking into account that dermal absorption is set at 10%, while oral absorption is set at 50% (in view of the systemic effects on liver and kidney seen in the repeated dose study) leads to the NOAEL of 50 mg/kg bw that is taken as starting point for the calculation of the DNEL.

AF for dose response relationship:
1
Justification:
the safety factor for extrapolation from LOAEL to NOAEL has already been included in the starting NOAEL
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
The species tested is the rat
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
consumer exposure
AF for the quality of the whole database:
1
Justification:
Based on guidelines study under GLP
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
65.6 mg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
90
Dose descriptor:
other: EC3 --> LOAEL
AF for dose response relationship:
3
Justification:
LOAEL to NOAEL default value
AF for differences in duration of exposure:
1
Justification:
not applicable
AF for interspecies differences (allometric scaling):
1
Justification:
not applicable
AF for other interspecies differences:
10
Justification:
default
AF for intraspecies differences:
1
AF for the quality of the whole database:
1
AF for remaining uncertainties:
3
Justification:
matrix effects
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 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):
100
Dose descriptor starting point:
other: LD50/NOAEL
Value:
2 000 mg/kg bw/day
AF for interspecies differences (allometric scaling):
4
Justification:
study in rat
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
consumer exposure

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population