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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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):
10
Modified dose descriptor starting point:
NOAEC
Value:
70.3 mg/m³
Explanation for the modification of the dose descriptor starting point:
Based on Guidance Document, Chapter R.8, Appendix R.8-2. A 10% absorption via oral vs. inhalation was assumed
AF for dose response relationship:
1
Justification:
Clear NOAEL value was assigned
AF for differences in duration of exposure:
2
Justification:
Extrapolation of sub-chronic to chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable, correction of oral to inhalation (rat to human) already performed
AF for other interspecies differences:
1
Justification:
Not applicable
AF for intraspecies differences:
5
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
The quality of the whole database was considered adequate
AF for remaining uncertainties:
1
Justification:
None identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 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:
400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Assumed equivalent bioavailability between oral and dermal routes of exposure
AF for dose response relationship:
1
Justification:
A clear NOAEL value was assigned
AF for differences in duration of exposure:
2
Justification:
Extrapolation for sub-chronic to chronic toxicity
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for the rat
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
The quality of the whole database was considered adequate
AF for remaining uncertainties:
1
Justification:
None identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Default procedures for the calculation of DNEL values were employed as described in the REACH technical guidance documents (Chapter 8).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.7 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):
20
Modified dose descriptor starting point:
NOAEC
Value:
34.8 mg/m³
Explanation for the modification of the dose descriptor starting point:
Based on Guidance Document, Chapter R.8, Appendix R.8-2. A 10% absorption via oral vs. inhalation was assumed
AF for dose response relationship:
1
Justification:
Clear NOAEL value was assigned
AF for differences in duration of exposure:
2
Justification:
Extrapolation of sub-chronic to chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable, correction of oral to inhalation (rat to human) already performed
AF for other interspecies differences:
1
Justification:
Not applicable
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
The quality of the whole database was considered adequate
AF for remaining uncertainties:
1
Justification:
None identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
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):
200
Modified dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Assumed equivalent bioavailability between oral and dermal routes of exposure
AF for dose response relationship:
1
Justification:
A clear NOAEL value was assigned
AF for differences in duration of exposure:
2
Justification:
Extrapolation of sub-chronic to chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for the rat
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
The quality of the whole database was considered adequate
AF for remaining uncertainties:
1
Justification:
None identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
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):
200
Modified dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable
AF for dose response relationship:
1
Justification:
A clear NOAEL value was assigned
AF for differences in duration of exposure:
2
Justification:
Extrapolation of sub-chronic to chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for the rat
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
The quality of the whole database was considered adequate
AF for remaining uncertainties:
1
Justification:
None identified
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:
low hazard (no threshold derived)

Additional information - General Population

Default procedures for the calculation of DNEL values were employed as described in the REACH technical guidance documents (Chapter 8).