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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.07 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):
37.5
Dose descriptor starting point:
NOAEL
Value:
2 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
2.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

Oral Dose modified in accordance with ECHA guidance to derive an Inhalation NOAEC

AF for dose response relationship:
1
Justification:
ECHA default - clear dose response with a Clear NOAEL
AF for differences in duration of exposure:
3
Justification:
Extrapolation from a mid-term study period to a chronic study period. In the 2011 publication of Batke et al. (2011) an analysis of the RepDose database to derive appropriate assessment factors for extrapolating a NOEL from a shorter to a longer term study was presented. The study determined that in many cases the default factors proposed in the ECHA guidance document are unnecessarily conservative and that in the case of rapidly metabolised substances that do not have the potential to bioaccumulate lower factors can be used to extrapolate from shorter to longer durations. The available data for this substance indicate it is not well absorbed, readily metabolised with a low volume of distribution and thus does not have the potential to bioaccumulate. Consequently a lower factor of 3 is considered appropriate for the duration extrapolation.
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA default - taken into account in route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
ECHA defauls
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Multiple studies available with consistent effects
AF for remaining uncertainties:
1
Justification:
No additional Uncertainties identified
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:
0.04 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):
150
Dose descriptor starting point:
NOAEL
Value:
2 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

ECHA default approach taking into consideration the differences in bioavailability via the oral and dermal route

AF for dose response relationship:
1
Justification:
ECHA Default
AF for differences in duration of exposure:
3
Justification:
Extrapolation from a mid-term study period to a chronic study period. In the 2011 publication of Batke et al. (2011) an analysis of the RepDose database to derive appropriate assessment factors for extrapolating a NOEL from a shorter to a longer term study was presented. The study determined that in many cases the default factors proposed in the ECHA guidance document are unnecessarily conservative and that in the case of rapidly metabolised substances that do not have the potential to bioaccumulate lower factors can be used to extrapolate from shorter to longer durations. The available data for this substance indicate it is not well absorbed, readily metabolised with a low volume of distribution and thus does not have the potential to bioaccumulate. Consequently a lower factor of 3 is considered appropriate for the duration extrapolation.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default - starting point is a study in rats
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Starting point for the DNEL derivation for all routes and durations is the NOAEL from the OECD 422 performed by MPU research in 2005.

The NOAEL was 2 mg/kg for both males and females and is based on both systemic toxicity and reproductive/developmental toxicity.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.017 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:
2 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1.3 mg/m³
Explanation for the modification of the dose descriptor starting point:

ECHA default approach for reoute to route extrapolation from Oral rat study to human inhalation exposure level.

AF for dose response relationship:
1
AF for differences in duration of exposure:
3
Justification:
Extrapolation from a mid-term study period to a chronic study period. In the 2011 publication of Batke et al. (2011) an analysis of the RepDose database to derive appropriate assessment factors for extrapolating a NOEL from a shorter to a longer term study was presented. The study determined that in many cases the default factors proposed in the ECHA guidance document are unnecessarily conservative and that in the case of rapidly metabolised substances that do not have the potential to bioaccumulate lower factors can be used to extrapolate from shorter to longer durations. The available data for this substance indicate it is not well absorbed, readily metabolised with a low volume of distribution and thus does not have the potential to bioaccumulate. Consequently a lower factor of 3 is considered appropriate for the duration extrapolation.
AF for interspecies differences (allometric scaling):
1
Justification:
Taken into consideration in the route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
0.02 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:
2 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

ECHA default approach for route to route extrapolation

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
3
Justification:
Extrapolation from a mid-term study period to a chronic study period. In the 2011 publication of Batke et al. (2011) an analysis of the RepDose database to derive appropriate assessment factors for extrapolating a NOEL from a shorter to a longer term study was presented. The study determined that in many cases the default factors proposed in the ECHA guidance document are unnecessarily conservative and that in the case of rapidly metabolised substances that do not have the potential to bioaccumulate lower factors can be used to extrapolate from shorter to longer durations. The available data for this substance indicate it is not well absorbed, readily metabolised with a low volume of distribution and thus does not have the potential to bioaccumulate. Consequently a lower factor of 3 is considered appropriate for the duration extrapolation.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default: Rat study is the starting point for DNEL derivation
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
ECHA default
AF for remaining uncertainties:
1
Justification:
ECHA default
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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