Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.7 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):
100
Dose descriptor starting point:
NOAEL
Value:
20 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
0.7 mg/m³
AF for dose response relationship:
1
Justification:
Starting point NOAEC (corrected)
AF for differences in duration of exposure:
2
Justification:
ECHA default
AF for interspecies differences (allometric scaling):
1
Justification:
Adjusted for inhalation
AF for other interspecies differences:
5
Justification:
Workers ECHA default
AF for intraspecies differences:
1
AF for the quality of the whole database:
1
Justification:
Sufficient to determine health outcomes
AF for remaining uncertainties:
2.5
Justification:
ECHA default
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.1 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
NOAEC
Value:
0.7 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
2.1 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to the ECHA Guidance, Appendix R 8.8, there is “no accepted methodology for determining acute dermal exposures, and protection is generally accommodated by more conservative long-term systemic DNELs” (p. 106).

One well-established method used to estimate an acute threshold limit value (TLV) is the multiplication of the long-term DNEL by a factor of 3 (Guidance R.8, Appendix R.8.8, p. 110, 2008, equivalent to dividing by 0.33

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:
0.2 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):
100
Dose descriptor starting point:
NOAEL
Value:
20 mg/m³
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
ECHA default
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to Human - ECHA default
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
ECHA default - worker
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Justification:
ECHA default
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:

According to the ECHA Guidance, Appendix R 8.8, there is “no accepted methodology for determining acute dermal exposures, and protection is generally accommodated by more conservative long-term systemic DNELs” (p. 106).

One well-established method used to estimate an acute threshold limit value (TLV) is the multiplication of the long-term DNEL by a factor of 3 (Guidance R.8, Appendix R.8.8, p. 110, 2008, equivalent to dividing by 0.33)

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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard 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

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard 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

General Population - Hazard via oral route

Systemic 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 for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population