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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:

There is no inhalation toxicity study available. The NOAEC is calculated as follows: oral NOAEL*(1/(0.38 m3/kg/d))*(ABSoral rat/ABSinh human)*(6.7 m3(8h)/10 m3(8h)) 

AF for dose response relationship:
1
Justification:
No assessment factor is needed as a NOAEL was used as starting dose descriptor.
AF for differences in duration of exposure:
6
Justification:
Standard factor for scaling of subacute to chronic duration of the study.
AF for interspecies differences (allometric scaling):
1
Justification:
This is taken into account in the calculation from NOAEL to NOAEC.
AF for other interspecies differences:
2.5
Justification:
Standard factor.
AF for intraspecies differences:
5
Justification:
Standard factor for worker.
AF for the quality of the whole database:
1
Justification:
DNEL is derived from a reliable repeated dose toxicity study
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties.
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:
26 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:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
7 874 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

There is no inhalation toxicity study available. The corrected dermal NOAEL is based on the available dermal absorption study and resulting skin absorption value of 12.7%.

AF for dose response relationship:
1
Justification:
No assessment factor is needed as a NOAEL was used as starting dose descriptor.
AF for differences in duration of exposure:
6
Justification:
Standard factor for scaling of subacute to chronic duration of the study.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor.
AF for other interspecies differences:
2.5
Justification:
Standard factor.
AF for intraspecies differences:
5
Justification:
Standard factor for worker.
AF for the quality of the whole database:
1
Justification:
DNEL is derived from a reliable repeated dose toxicity study.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties.
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:
DNEL (Derived No Effect Level)
Value:
2 050 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
No assessment factor is needed as a no effect concentration was used as starting dose descriptor.
AF for interspecies differences (allometric scaling):
1
Justification:
There are no interspecies differences as the study was performed in human.
AF for other interspecies differences:
1
Justification:
There are no interspecies differences as the study was performed in human.
AF for intraspecies differences:
10
Justification:
Standard factor for general population.
AF for the quality of the whole database:
1
Justification:
Threshold is derived from a reliable hRIPT.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties.

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low 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:
5.7 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
869 mg/m³
Explanation for the modification of the dose descriptor starting point:

There is no inhalation toxicity study available. The NOAEC is calculated as follows: oral NOAEL*(1/(1.15 m3/kg/d))*(ABSoral rat/ABSinh human).

AF for dose response relationship:
1
Justification:
No assessment factor is needed as a NOAEL was used as starting dose descriptor.
AF for differences in duration of exposure:
6
Justification:
Standard factor for scaling of subacute to chronic duration of the study.
AF for interspecies differences (allometric scaling):
1
Justification:
This is taken into account in the calculation from NOAEL to NOAEC.
AF for other interspecies differences:
2.5
Justification:
Standard factor.
AF for intraspecies differences:
10
Justification:
Standard factor for general population.
AF for the quality of the whole database:
1
Justification:
DNEL is derived from a reliable repeated dose toxicity study
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties.
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:
13 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:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
7 874 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

There is no inhalation toxicity study available. The corrected dermal NOAEL is based on the available dermal absorption study and resulting skin absorption value of 12.7%.

AF for dose response relationship:
1
Justification:
No assessment factor is needed as a NOAEL was used as starting dose descriptor.
AF for differences in duration of exposure:
6
Justification:
Standard factor for scaling of subacute to chronic duration of the study.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor.
AF for other interspecies differences:
2.5
Justification:
Standard factor.
AF for intraspecies differences:
10
Justification:
Standard factor for general population.
AF for the quality of the whole database:
1
Justification:
DNEL is derived from a reliable repeated dose toxicity study.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties.
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:
DNEL (Derived No Effect Level)
Value:
2 050 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
No assessment factor is needed as a no effect concentration was used as starting dose descriptor.
AF for interspecies differences (allometric scaling):
1
Justification:
There are no interspecies differences as the study was performed in human.
AF for other interspecies differences:
1
Justification:
There are no interspecies differences as the study was performed in human.
AF for intraspecies differences:
10
Justification:
Standard factor for general population.
AF for the quality of the whole database:
1
Justification:
Threshold is derived from a reliable hRIPT.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties.

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.6 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:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The most relevant NOAEL for oral DNELs is 1000 mg/kg bw/d determined in a combined 28-day repeated dose toxicity (OECD 422) study.

AF for dose response relationship:
1
Justification:
No assessment factor is needed as a NOAEL was used as starting dose descriptor.
AF for differences in duration of exposure:
6
Justification:
Standard factor for scaling of subacute to chronic duration of the study.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor.
AF for other interspecies differences:
2.5
Justification:
Standard factor.
AF for intraspecies differences:
10
Justification:
Standard factor for general population.
AF for the quality of the whole database:
1
Justification:
DNEL is derived from reliable repeated dose toxicity study.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population