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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
9.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
18
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
176 mg/m³
AF for dose response relationship:
1
Justification:
Starting point is a NOAEL
AF for differences in duration of exposure:
6
Justification:
subacute to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
not applicable for oral to inhalation extrapolation
AF for other interspecies differences:
1
Justification:
based on pulmonary physiology and clearance dynamics of particulate matters/aerosols, no differences in absorption rate to be expected.
AF for intraspecies differences:
3
Justification:
analysis of various data sets have revealed that for workers a factor of 3 is sufficient for covering any intraspecies variability (ECETOC, 2010)
AF for the quality of the whole database:
1
Justification:
consistent and pertinent
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:
14 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
72
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
AF for dose response relationship:
1
Justification:
starting point is a NOAEL
AF for differences in duration of exposure:
6
Justification:
from subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling from rat to human
AF for other interspecies differences:
1
Justification:
included in the variability assessment
AF for intraspecies differences:
3
Justification:
Analysis of various data sets have revealed that for workers a factor of 3 is sufficient for covering any intraspecies variability (ECETOC, 2010)
AF for the quality of the whole database:
1
Justification:
complete and consistent
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:
high hazard (no threshold derived)

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:
DNEL (Derived No Effect Level)
Value:
0.83 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
120
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
AF for dose response relationship:
1
Justification:
starting point is a NOAEL
AF for differences in duration of exposure:
6
Justification:
from subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling from rat to human
AF for other interspecies differences:
1
Justification:
included in variability assessment
AF for intraspecies differences:
5
Justification:
Analysis of various data sets have revealed that for general population a factor of 5 is sufficient for covering any intraspecies variability (ECETOC, 2010)
AF for the quality of the whole database:
1
Justification:
complete and consistent
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

For the delineation of DNELs the following exposure patterns are considered:

 

Oral DNEL (general population via the environment):

Identified key study for DNEL derivation is a 28-day oral toxicity study in rats (Hoechst, 1990) which results in a NOAEL of 100 mg/kg body weight per day. Route to route extrapolation must therefore be not applied.

DNEL Value based on the Corrected oral systemic NOAEL = 100 mg/kg bw/d:

 

= 100 /(4 x 5 x 6 x 1 x 1) = 0.833 mg/kg bw/ day