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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7.05 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):
75
Modified dose descriptor starting point:
NOAEC
Value:
528.95 mg/m³
Explanation for the modification of the dose descriptor starting point:
No repeat dose inhalation data available, only NOAEL (oral).
AF for dose response relationship:
1
Justification:
NOAEC
AF for differences in duration of exposure:
6
Justification:
Standard default sub-acute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not applied as NOAEC is used.
AF for other interspecies differences:
2.5
Justification:
Standard default
AF for intraspecies differences:
5
Justification:
Standard default for workers
AF for the quality of the whole database:
1
Justification:
Data available on substance
AF for remaining uncertainties:
1
Justification:
None known
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 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
Modified dose descriptor starting point:
NOAEL
Value:
600 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No repeat dose dermal data available, only NOAEL (oral).
AF for dose response relationship:
1
Justification:
NOAEL
AF for differences in duration of exposure:
6
Justification:
Standard default, sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Standard default rat to human
AF for other interspecies differences:
2.5
Justification:
Standard default
AF for intraspecies differences:
5
Justification:
Standard default for workers
AF for the quality of the whole database:
1
Justification:
Data available on substance
AF for remaining uncertainties:
1
Justification:
None known
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The inhalation DNEL for long term exposure (systemic effects) was based on the oral 28-Day study, in which a NOAEL of 600mg/kg/day was established. The assessment factors were: Allometric scaling (1), remaining differences (2.5), workers (5), exposure duration (6), dose response (1), quality (1).

The dermal DNEL for long term exposure (systemic effects) was based on the oral 28-Day study, in which a NOAEL of 600 mg/kg/day was established. The assessment factors were: Rat (4), remaining differences (2.5), workers (5), exposure duration (6), dose response (1), quality (1).

The dermal DNEL for long term exposure (local effects) was based on the LLNA study, in which a NOAEL of 50% in 25µl liquid was established. The assessment factors were: Rat (10), workers (5), exposure duration (10), 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.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.74 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):
150
Modified dose descriptor starting point:
NOAEC
Value:
260.87 mg/m³
Explanation for the modification of the dose descriptor starting point:
No repeat dose inhalation data available, only NOAEL (oral).
AF for dose response relationship:
1
Justification:
NOAEC
AF for differences in duration of exposure:
6
Justification:
Standard default sub-acute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not applied as NOAEC is used.
AF for other interspecies differences:
2.5
Justification:
Standard default
AF for intraspecies differences:
10
Justification:
Standard default for general population
AF for the quality of the whole database:
1
Justification:
Data available on substance
AF for remaining uncertainties:
1
Justification:
None known
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 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
Modified dose descriptor starting point:
NOAEL
Value:
600 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No repeat dose dermal data available, only NOAEL (oral).
AF for dose response relationship:
1
Justification:
NOAEL
AF for differences in duration of exposure:
6
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
standard AS rat
AF for other interspecies differences:
2.5
Justification:
Standard default
AF for intraspecies differences:
10
Justification:
Standard default for general population
AF for the quality of the whole database:
1
Justification:
Data available on substance
AF for remaining uncertainties:
1
Justification:
None known
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
600 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
Modified dose descriptor starting point:
NOAEL
Value:
600 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
direct - oral study, no extrapolation required
AF for dose response relationship:
1
Justification:
NOAEL
AF for differences in duration of exposure:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
standard AS rat
AF for other interspecies differences:
2.5
Justification:
standard default
AF for intraspecies differences:
10
Justification:
standard - general population
AF for the quality of the whole database:
1
Justification:
Data available on substance
AF for remaining uncertainties:
1
Justification:
None known
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The inhalation DNEL for long term exposure (systemic effects) was based on the oral 28-Day study, in which a NOAEL of 600mg/kg/day was established. The assessment factors were: Allometric scaling (4), remaining differences (2.5), general population (10), exposure duration (6), dose response (1), quality (1).

The dermal DNEL for long term exposure (systemic effects) was based on the oral 28-Day study, in which a NOAEL of 600 mg/kg/day was established. The assessment factors were: Rat (4), remaining differences (2.5), general population (10), exposure duration (6), dose response (1), quality (1).

The dermal DNEL for long term exposure (local effects) was based on the LLNA study, in which a NOAEL of 50% in 25µl liquid was established. The assessment factors were: Rat (10), general population (10), exposure duration (10), 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 600 mg/kg/day was established. The assessment factors were: Rat (4), remaining differences (2.5), general population (10), exposure duration (6), 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.