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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.26 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Value:
31.54 mg/m³
AF for dose response relationship:
1
Justification:
An assessment factor of 1 is applicable when the starting point is a NOAEL.
AF for differences in duration of exposure:
2
Justification:
Default ECHA AF for subchronic to chronic studies, applicable to results from sub-chronic (90 day) study.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling omitted since differences in breathing (rat to human) accounted for in modification of starting point.
AF for other interspecies differences:
2.5
Justification:
ECHA default AF for remaining differences
AF for intraspecies differences:
5
Justification:
ECHA default AF for worker population
AF for the quality of the whole database:
1
Justification:
Key study is considered reliable and the database is comprehensive.
AF for remaining uncertainties:
1
Justification:
None considered relevant.
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.075 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):
100
Modified dose descriptor starting point:
NOAEL
Value:
7.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Route to route extrapolation required for oral to dermal route as no long term dermal study available.
AF for dose response relationship:
1
Justification:
An assessment factor of 1 is applicable when the starting point is a NOAEL
AF for differences in duration of exposure:
2
Justification:
Default ECHA AF for subchronic to chronic studies, applicable to results from sub-chronic (90 day) study.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default AF for allometric scaling for rats to humans
AF for other interspecies differences:
2.5
Justification:
ECHA default AF for remaining differences
AF for intraspecies differences:
5
Justification:
ECHA default AF for worker population
AF for the quality of the whole database:
1
Justification:
Key study is considered reliable and the database is comprehensive.
AF for remaining uncertainties:
1
Justification:
None considered relevant.
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The worker DNELs derived for long-term systemic effects (inhalation and dermal) have been derived using standard assessment factors as recommended by ECHA (Guidance on information requirements and chemical safety assessment; Chapter R.8: Characterisation of dose [concentration]-response for human health).

The substance is classified for acute toxicity for inhalation and dermal routes, but acute systemic DNELs are not derived as available acute studies do not provide sufficient dose-response relationship data. In addition the long-term DNELs are protective of short-term exposure because the industrial environment is strictly moderated, high peak exposures are not expected, and risk management measures will prevent inhalation and dermal exposure.

The substance may have some potential to cause irritation, but local DNELs are not derived as systemic toxicity is the primary human health concern and the industrial measures in place to prevent exposure will also cover local effects.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.31 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Value:
15.69 mg/m³
AF for dose response relationship:
1
Justification:
An assessment factor of 1 is applicable when the starting point is a NOAEL.
AF for differences in duration of exposure:
2
Justification:
Default ECHA AF for subchronic to chronic studies, applicable to results from sub-chronic (90 day) study.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling omitted since differences in breathing (rat to human) accounted for in modification of starting point.
AF for other interspecies differences:
2.5
Justification:
ECHA default AF for remaining differences
AF for intraspecies differences:
10
Justification:
ECHA default AF for general population
AF for the quality of the whole database:
1
Justification:
Key study is considered reliable and the database is comprehensive.
AF for remaining uncertainties:
1
Justification:
None considered relevant.
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.037 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
7.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Route to route extrapolation required for oral to dermal route as no long term dermal study available.
AF for dose response relationship:
1
Justification:
An assessment factor of 1 is applicable when the starting point is a NOAEL.
AF for differences in duration of exposure:
2
Justification:
Default ECHA AF for subchronic to chronic studies, applicable to results from sub-chronic (90 day) study.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default AF for allometric scaling for rats to humans
AF for other interspecies differences:
2.5
Justification:
ECHA default AF for remaining differences
AF for intraspecies differences:
10
Justification:
ECHA default AF for general population
AF for the quality of the whole database:
1
Justification:
Key study is considered reliable and the database is comprehensive.
AF for remaining uncertainties:
1
Justification:
None considered relevant.
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
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)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.037 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
7.5 mg/kg bw/day
AF for dose response relationship:
1
Justification:
An assessment factor of 1 is applicable when the starting point is a NOAEL.
AF for differences in duration of exposure:
2
Justification:
Default ECHA AF for subchronic to chronic studies, applicable to results from sub-chronic (90 day) study.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default AF for allometric scaling for rats to humans
AF for other interspecies differences:
2.5
Justification:
ECHA default AF for remaining differences
AF for intraspecies differences:
10
Justification:
ECHA default AF for general population
AF for the quality of the whole database:
1
Justification:
Key study is considered reliable and the database is comprehensive.
AF for remaining uncertainties:
1
Justification:
None considered relevant.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

All uses of the substance are industrial. There are no general public/consumer uses so no exposure is expected.

No exposure of the general population is expected under normal industrial operating conditions. Nevertheless, long-term systemic DNELs have been calculated in case it becomes necessary to assess long-term exposure from articles and any indirect exposure from the environment.