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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
29 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):
30
Modified dose descriptor starting point:
NOAEC
Value:
875 mg/m³
Explanation for the modification of the dose descriptor starting point:
Due to vapour pressure and particle size distribution, inhalable / respirable particles are negligible. Any nuisance dust ingested will remain in the mouth/nose with the potential for subsequent oral exposure. Hence NOAEL for oral toxicity is considered the appropriate endpoint for hazard assessment. Therefore, oral absorption in rat is assumed to be 100 % and inhalation absorption in humans is assumed to be 100 %. Corrected NOAEC (inhalation) = NOAEL (oral rat) / AS * BW(human) / Hrv. Allometric scaling factor: 4; BW (human) = 70 kg Hrv = Human respiration rate = 10 m³ / person. Therefore, corrected NOAEC (inhalation) = 875 mg/m³ (500/4 * 70/10)
AF for dose response relationship:
1
Justification:
Default assessment factor when the starting point for the DNEL calculation is a NOAEC
AF for differences in duration of exposure:
6
Justification:
Default assessment factor for extrapolation from subacute to chronic - for worst case
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling done at route to route extrapolation step in accordance with left hand side of Example R. 8-2 of Appendix R. 8-2, part 1.
AF for other interspecies differences:
1
Justification:
Allometric scaling factor considered sufficient to account for interspecies differences when calculated from human NOAEC
AF for intraspecies differences:
5
Justification:
Default assessment factor of 5 for workers
AF for the quality of the whole database:
1
Justification:
GLP study conducted in accordance with OECD Guideline.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL extrapolated from long term DNEL

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.17 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):
120
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
An oral absorption in rat of 100 % and a dermal absorption in humans of 100 % has been used as a worst case assumption.
AF for dose response relationship:
1
Justification:
Default assessment factor when the starting point for the DNEL calculation is a NOAEL.
AF for differences in duration of exposure:
6
Justification:
Default assessment factor for extrapolation from subacute to chronic - as worst case assumption
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling factor for rat compared with humans is four.
AF for other interspecies differences:
1
Justification:
Allometric scaling factor considered sufficient to account for interspecies differences.
AF for intraspecies differences:
5
Justification:
Default assessment factor of 5 is used for workers.
AF for the quality of the whole database:
1
Justification:
GLP study conducted in accordance with OECD Guideline.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

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:
14.6 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):
60
Modified dose descriptor starting point:
NOAEC
Value:
875 mg/m³
Explanation for the modification of the dose descriptor starting point:
Due to vapour pressure and particle size distribution, inhalable / respirable particles are negligible. Any nuisance dust ingested will remain in the mouth/nose with the potential for subsequent oral exposure. Therefore, 100 % oral absorption in rats is assumed and 100 % inhalation absorption in humans is assumed. Corrected NOAEC (inhalation) = NOAEL (oral rat) / AS * BW(human) / Hrv. Allometric scaling factor: 4; BW (human) = 70 kg Hrv = Human respiration rate = 20 m3 / person. Therefore, corrected NOAEC (inhalation) = 875 mg/m³ (1000/4 * 70/20)
AF for dose response relationship:
1
Justification:
Default assessment factor when the starting point for the DNEL calculation is a NOAEL.
AF for differences in duration of exposure:
6
Justification:
Default assessment factor for extrapolation from subacute to chronic - as worst case assumption.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling done at route to route extrapolation step in accordance with left hand side of Example R. 8-2 of Appendix R. 8-2, part 1.
AF for other interspecies differences:
1
Justification:
Allometric scaling factor considered sufficient to account for interspecies differences.
AF for intraspecies differences:
10
Justification:
Default assessment factor of 10 is used for general population.
AF for the quality of the whole database:
1
Justification:
GLP study conducted in accordance with OECD Guideline.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL extrapolated from long term DNEL

General Population - 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:
ECHA REACH Guidance
Overall assessment factor (AF):
240
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
An oral absorption in rat of 100 % and a dermal absorption in humans of 100 % has been used as a worst case assumption.
AF for dose response relationship:
1
Justification:
Default assessment factor when the starting point for the DNEL calculation is a NOAEL.
AF for differences in duration of exposure:
6
Justification:
Default assessment factor for extrapolation from subacute to chronic - as worst case assumption.
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling factor for rat compared with humans is 4.
AF for other interspecies differences:
1
Justification:
Allometric scaling factor considered sufficient to account for interspecies differences.
AF for intraspecies differences:
10
Justification:
Default assessment factor for general population is 10.
AF for the quality of the whole database:
1
Justification:
GLP study conducted in accordance with OECD Guideline.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

General Population - Hazard via oral 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:
ECHA REACH Guidance
Overall assessment factor (AF):
240
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Route to route extrapolation not required.
AF for dose response relationship:
1
Justification:
Default assessment factor when the starting point for the DNEL calculation is a NOAEL.
AF for differences in duration of exposure:
6
Justification:
Default assessment factor for extrapolation from subacute to chronic - as worst case assumption.
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling factor for rat compared with humans is 4.
AF for other interspecies differences:
1
Justification:
Allometric scaling factor considered sufficient to account for interspecies differences.
AF for intraspecies differences:
10
Justification:
Default assessment factor for the general population.
AF for the quality of the whole database:
1
Justification:
GLP study conducted in accordance with OECD Guideline.
AF for remaining uncertainties:
1
Justification:
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