Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.67 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:
875 mg/m³
Explanation for the modification of the dose descriptor starting point:
No long term inhalation study is available therefore route to route extrapolation has been used.
AF for dose response relationship:
1
Justification:
This is a default assessment factor for using the NOAEL as the result. This assessment factor was used based on guidance documents released by the ECHA.
AF for differences in duration of exposure:
6
Justification:
Default assessment factor based upon the ECHAs guidance. In this case the assessment factor is 6 as we have an OECD 422 study which is classed as sub-acute.
AF for interspecies differences (allometric scaling):
1
Justification:
This has been set to a default value of 1 as the inter species variability has already been looked into while calculating the modified dose descriptor.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor used, the value was obtained from guidance documents released by the ECHA
AF for intraspecies differences:
5
Justification:
This is the default assessment factor for looking into intraspecies differences, this assessment factor was obtained from ECHA's guidance and is applicable just for workers.
AF for the quality of the whole database:
1
Justification:
A klimisch reliability of 1 was assigned to the study based on the klimisch reliability scale. This assessment factor was used based on guidance documents from the ECHA.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties, therefore a default assessment factor of 1 can be used.
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:
3.3 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:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No long term dermal study available.
AF for dose response relationship:
1
Justification:
This is a default assessment factor for using the NOAEL as the result. This assessment factor was used based on guidance documents released by the ECHA
AF for differences in duration of exposure:
6
Justification:
default assessment factor based upon the ECHAs guidance
AF for interspecies differences (allometric scaling):
4
Justification:
default assessment factor based on allometric scaling for rats
AF for other interspecies differences:
2.5
Justification:
default assessment factor used, the value was obtained from guidance by the ECHA
AF for intraspecies differences:
5
Justification:
default assessment factor looking into intraspecies differences, this assessment factor was obtained from ECHA's guidance.
AF for the quality of the whole database:
1
Justification:
A klimisch reliability of 1 was assigned to the study based on the klimisch reliability scale. This assessment factor was used based on guidance documents from the ECHA.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties, therefore a default assessment factor of 1 can be used.
Acute/short term exposure
DNEL related information

Local effects

Long 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 following DNELs were worked out for workers:

Systemic long term exposure - inhalation:

DNEL was worked out to be 11.67 mg/m3 using route to route extrapolation as there was no long term inhalation data available.

Systemic long term exposure - dermal:

DNEL was worked out to be 3.3 mg/kg/bw/day using route to route extrapolation as no long term dermal study was available.

Systemic long term exposure - oral:

This is not required to be worked out for workers

Acute/short term DNELs for all routes of exposure: The substance is not classified for Acute toxicity and therefore none of the acute DNELs have been calculated.

Local DNELs - None of the local DNELs have been calculated as the test material has been found to show no local effects, for example the test material is not a skin irritant, eye irritant or skin sensitiser and due to this, no local DNELs have been calculated.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.92 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:
437.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
We are using route to route extrapolation as we have no long term inhalation data.
AF for dose response relationship:
1
Justification:
This is a default assessment factor for using the NOAEL as the result. This assessment factor was used based on guidance documents released by the ECHA
AF for differences in duration of exposure:
6
Justification:
Default assessment factor based upon the ECHAs guidance. In this case our study is a subacute study, therefore our assessment factor for duration of exposure is 6.
AF for interspecies differences (allometric scaling):
1
Justification:
This has been set to a default value of 1 as the inter species variability has already been looked into while calculating the modified dose descriptor.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor used, the value was obtained from guidance documents released by the ECHA.
AF for intraspecies differences:
10
Justification:
This is the default assessment factor for the general population, this value has been obtained from the ECHA's guidance.
AF for the quality of the whole database:
1
Justification:
A klimisch reliability of 1 was assigned to the study based on the klimisch reliability scale. This assessment factor was used based on guidance documents from the ECHA.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties, therefore a default assessment factor of 1 can be used.
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)
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Value:
1.67 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
route to route extrapolation was used as no long term data via the dermal route is available.
AF for dose response relationship:
1
Justification:
This is a default assessment factor for using the NOAEL as the result. This assessment factor was used based on guidance documents released by the ECHA.
AF for differences in duration of exposure:
6
Justification:
Default assessment factor based upon the ECHAs guidance. In this case our study is a subacute study, therefore our assessment factor for duration of exposure is 6.
AF for interspecies differences (allometric scaling):
4
Justification:
default assessment factor based on allometric scaling for rats
AF for other interspecies differences:
2.5
Justification:
Default assessment factor used, the value was obtained from guidance documents released by the ECHA.
AF for intraspecies differences:
10
Justification:
This is the default assessment factor for the general population, this value has been obtained from the ECHA's guidance.
AF for the quality of the whole database:
1
Justification:
A klimisch reliability of 1 was assigned to the study based on the klimisch reliability scale. This assessment factor was used based on guidance documents from the ECHA.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties, therefore a default assessment factor of 1 can be used.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
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)
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:
1.67 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Route to route extrapolation is not required as we have an OECD 422 study via the oral route.
AF for dose response relationship:
1
Justification:
This is a default assessment factor for using the NOAEL as the result. This assessment factor was used based on guidance documents released by the ECHA.
AF for differences in duration of exposure:
6
Justification:
Default assessment factor based upon the ECHAs guidance. In this case our study is a subacute study, therefore our assessment factor for duration of exposure is 6.
AF for interspecies differences (allometric scaling):
4
Justification:
default assessment factor based on allometric scaling for rats
AF for other interspecies differences:
2.5
Justification:
Default assessment factor used, the value was obtained from guidance documents released by the ECHA.
AF for intraspecies differences:
10
Justification:
This is the default assessment factor for the general population, this value has been obtained from the ECHA's guidance.
AF for the quality of the whole database:
1
Justification:
A klimisch reliability of 1 was assigned to the study based on the klimisch reliability scale. This assessment factor was used based on guidance documents from the ECHA.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties, therefore a default assessment factor of 1 can be used.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The following DNELs were worked out for the general population

Systemic long term exposure - inhalation:

DNEL was worked out to be 2.92 mg/m3using route to route extrapolation as there was no long term inhalation data available.

Systemic long term exposure - dermal:

DNEL was worked out to be 1.67 mg/kg/bw/day using route to route extrapolation as no long term dermal study was available.

Systemic long term exposure - oral:

The DNEL was worked out to be 1.67 mg/kg/bw day based upon the result of the OECD 422 study via the oral route (NOAEL of 1000).

Local DNELs - None of the local DNELs have been calculated as the test material has been found to show no local effects, for example the test material is not a skin irritant, eye irritant or skin sensitiser and due to this, no local DNELs have been calculated.

Acute/short term DNELs for all routes of exposure: The substance is not classified for Acute toxicity and therefore none of the acute DNELs have been calculated.