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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
12
Modified dose descriptor starting point:
NOAEC
Value:
88 mg/m³
Explanation for the modification of the dose descriptor starting point:

There is no indication that route-to-route extrapolation cannot be applied.

AF for dose response relationship:
2
Justification:
Value is NOAEL; study has been performed with analogue
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic study to chronic exposure worker
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling rat human included in dose descriptor starting point
AF for other interspecies differences:
1
Justification:
Not relevant
AF for intraspecies differences:
3
Justification:
Differences in sensitivity amongst workers
AF for the quality of the whole database:
1
Justification:
Not relevant, reliable studies and all endpoints required are covered adequately
AF for remaining uncertainties:
1
Justification:
Not relevant (no remaining uncertainties)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local 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:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
48
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

kinetics (metabolism, distribution and excretion) are considered to be similar for oral and dermal exposure in the absence of evidence of the opposite

AF for dose response relationship:
2
Justification:
Value is NOAEL; study has been performed with analogue
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic study to chronic exposure worker
AF for interspecies differences (allometric scaling):
4
Justification:
Correction for caloric demand from rat to human
AF for other interspecies differences:
1
Justification:
Not relevant
AF for intraspecies differences:
3
Justification:
Differences in sensitivity amongst workers
AF for the quality of the whole database:
1
Justification:
Not relevant, reliable studies and all endpoints required are covered adequately
AF for remaining uncertainties:
1
Justification:
Not relevant (no remaining uncertainties)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local 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:
hazard unknown but no further hazard information necessary as no exposure expected

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:
DNEL (Derived No Effect Level)
Value:
2.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEC
Value:
43.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

There is no indication that route-to-route extrapolation cannot be applied.

AF for dose response relationship:
2
Justification:
Value is NOAEL; study has been performed with analogue
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic study to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling rat human included in dose descriptor starting point
AF for other interspecies differences:
1
Justification:
Not relevant
AF for intraspecies differences:
5
Justification:
Differences in sensitivity amongst general population
AF for the quality of the whole database:
1
Justification:
Not relevant, reliable studies and all endpoints required are covered adequately
AF for remaining uncertainties:
1
Justification:
Not relevant (no remaining uncertainties)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local 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:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
80
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

There is no indication that route-to-route extrapolation cannot be applied.

AF for dose response relationship:
2
Justification:
Value is NOAEL; study has been performed with analogue
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic study to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
1
Justification:
No remaining differences
AF for intraspecies differences:
5
Justification:
Differences in sensitivity amongst general population
AF for the quality of the whole database:
1
Justification:
Not relevant, reliable studies and all endpoints required are covered adequately
AF for remaining uncertainties:
1
Justification:
Not relevant (no remaining uncertainties)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local 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:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
80
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Not relevant.

AF for dose response relationship:
2
Justification:
Value is NOAEL; study has been performed with analogue
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic study to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
1
Justification:
Not relevant
AF for intraspecies differences:
5
Justification:
Differences in sensitivity amongst general population
AF for the quality of the whole database:
1
Justification:
Not relevant, reliable study and all endpoints required are covered adequately
AF for remaining uncertainties:
1
Justification:
Not relevant (no remaining uncertainties)
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