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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
92.75 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
37.5
Modified dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
AF for differences in duration of exposure:
3
AF for interspecies differences (allometric scaling):
1
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2.5
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.67 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEL
AF for dose response relationship:
1
AF for differences in duration of exposure:
3
AF for interspecies differences (allometric scaling):
4
AF for intraspecies differences:
5
AF for remaining uncertainties:
2.5
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

The dermal DNEL for long term exposure was based on the 28-Day oral study in which a NOAEL of 1000 mg/kg/day was established. In accordance with the guidelines, the following assessment factors used were: Rat (4), remaining differences (2.5), workers (5), exposure duration (3), dose response (1), quality (1).

The inhalation DNEL for long term exposure (systemic effects) was based on the oral 28-Day study, in which a NOAEL of 1000mg/kg/day was established. The assessment factors were: Allometric scaling (1), remaining differences (2.5), workers (5), exposure duration (3), dose response (1), quality (1).

As no acute effects were recorded and no classification and labelling is necessary, no acute DNEL is derived in accordance with the guidance. It is assumed that the long term DNEL is sufficient to ensure acute effects do not occur. Furthermore, no DNELs for local effects have been derived as no local effects were observed.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.15 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
AF for differences in duration of exposure:
3
AF for interspecies differences (allometric scaling):
1
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2.5
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
AF for dose response relationship:
1
AF for differences in duration of exposure:
3
AF for interspecies differences (allometric scaling):
4
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2.5
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
AF for dose response relationship:
1
AF for differences in duration of exposure:
3
AF for interspecies differences (allometric scaling):
4
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2.5
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The dermal DNEL for long term exposure (systemic effects) was based on the oral 28-Day study, in which a NOAEL of 1000 mg/kg/day was established. The assessment factors were: Rat (4), remaining differences (2.5), workers (5), exposure duration (3), dose response (1), quality (1).

The inhalation DNEL for long term exposure (systemic effects) was based on the oral 28-Day study, in which a NOAEL of 1000 mg/kg/day was established. The assessment factors were: Allometric scaline (1), remaining differences (2.5), general public (10), exposure duration (3), dose response (1), quality (1).

The oral DNEL for long term exposure (systemic effects) was based on the oral 28-Day study, in which a NOAEL of 1000mg/kg/day was established. The assessment factors were: Rat (4), remaining differences (2.5), workers (5), exposure duration (3), dose response (1), quality (1).

The oral DNEL for long term exposure (systemic effects) was based on the oral 28-Day study, in which a NOAEL of 1000mg/kg/day was established. The assessment factors were: Rat (4), remaining differences (2.5), workers (5), exposure duration (3), dose response (1), quality (1).