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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
85 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: Based on inhalation OEL for tetraethyl orthosilicate
Overall assessment factor (AF):
1
Modified dose descriptor starting point:
other: OEL
Value:
85 mg/m³
Explanation for the modification of the dose descriptor starting point:
N/A based on inhalation OEL
AF for dose response relationship:
1
Justification:
N/A based on OEL
AF for differences in duration of exposure:
1
Justification:
N/A based on OEL
AF for interspecies differences (allometric scaling):
1
Justification:
N/A based on OEL
AF for other interspecies differences:
1
Justification:
N/A based on OEL
AF for intraspecies differences:
1
Justification:
N/A based on OEL
AF for the quality of the whole database:
1
Justification:
N/A based on OEL
AF for remaining uncertainties:
1
Justification:
N/A based on OEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
85 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: Based on inhalation OEL for tetraethyl orthosilicate
Overall assessment factor (AF):
1
DNEL extrapolated from long term DNEL

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:
12 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: Based on inhalation OEL for tetraethyl orthosilicate
Overall assessment factor (AF):
1
Modified dose descriptor starting point:
other: OEL
Value:
12 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The repeated oral and inhalation studies suggest similar effects, such as those on the kidneys, irrespective of route of exposure. If the respiratory rate (8 hour) of a worker is assumed to be 10 m3/person with a body weight of 70 kg the corrected NOAEL(dermal) is therefore: = 85 mg/m3 * 10 m3/70 kg = 12 mg/kg bw/day (8 hour day)
AF for dose response relationship:
1
Justification:
N/A based on OEL
AF for differences in duration of exposure:
1
Justification:
N/A based on OEL
AF for interspecies differences (allometric scaling):
1
Justification:
N/A based on OEL
AF for other interspecies differences:
1
Justification:
N/A based on OEL
AF for intraspecies differences:
1
Justification:
N/A based on OEL
AF for the quality of the whole database:
1
Justification:
N/A based on OEL
AF for remaining uncertainties:
1
Justification:
N/A based on OEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: Based on inhalation OEL for tetraethyl orthosilicate
Overall assessment factor (AF):
1
DNEL extrapolated from long term DNEL

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:
DNEL (Derived No Effect Level)
Value:
21 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: Based on inhalation OEL for tetraethyl orthosilicate
Overall assessment factor (AF):
2
Modified dose descriptor starting point:
other:
Value:
42.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
N/A inhalation OEL used. It is assumed that the OEL applies to workers and consumers, and that exposure should be no more than 85 mg/m3 for an 8 hour exposure period. Therefore the equivalent exposure limit for consumers with 20 m3/person respiratory volume is: 85 mg/hour*10m3/day/20 m3/day = 42.5 mg/m3
AF for dose response relationship:
1
Justification:
N/A based on OEL
AF for differences in duration of exposure:
1
Justification:
N/A based on OEL
AF for interspecies differences (allometric scaling):
1
Justification:
N/A based on OEL
AF for other interspecies differences:
1
Justification:
N/A based on OEL
AF for intraspecies differences:
2
Justification:
Assessment factor for difference in susceptibility of consumers compared with workers, assuming that the OEL already incorporates an assessment factor of 5 for workers
AF for the quality of the whole database:
1
Justification:
N/A based on OEL
AF for remaining uncertainties:
1
Justification:
N/A based on OEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: Based on inhalation OEL for tetraethyl orthosilicate
Overall assessment factor (AF):
2
DNEL extrapolated from long term DNEL

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:
DNEL (Derived No Effect Level)
Value:
6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: Based on inhalation OEL for tetraethyl orthosilicate
Overall assessment factor (AF):
2
Modified dose descriptor starting point:
other:
Value:
12.1 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The repeated oral and inhalation studies suggest similar effects, such as those on the kidneys, irrespective of route of exposure. It is assumed that the OEL applies to workers and consumers, and that exposure should be no more than 85 mg/m3 for an 8 hour exposure period. If the respiratory rate (24 hour) of a consumer is assumed to be 10 m3/person with a body weight of 70 kg the corrected NOAEL(dermal) is therefore: = 85 mg/m3*10 m3/70 kg = 12.1mg/kg bw/day
AF for dose response relationship:
1
Justification:
N/A based on OEL
AF for differences in duration of exposure:
1
Justification:
N/A based on OEL
AF for interspecies differences (allometric scaling):
1
Justification:
N/A based on OEL
AF for other interspecies differences:
2
Justification:
Assessment factor for difference in susceptibility of consumers compared with workers, assuming that the OEL already incorporates an assessment factor of 5 for workers
AF for intraspecies differences:
1
Justification:
N/A based on OEL
AF for the quality of the whole database:
1
Justification:
N/A based on OEL
AF for remaining uncertainties:
1
Justification:
N/A based on OEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: Based on inhalation OEL for tetraethyl orthosilicate
Overall assessment factor (AF):
2
DNEL extrapolated from long term DNEL

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:
6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: Based on inhalation OEL for tetraethyl orthosilicate
Overall assessment factor (AF):
2
Modified dose descriptor starting point:
other:
Value:
12.1 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The repeated oral and inhalation studies suggest similar effects, such as those on the kidneys, irrespective of route of exposure. It is assumed that the OEL applies to workers and consumers, and that exposure should be no more than 85 mg/m3 for an 8 hour exposure period. If the respiratory rate (24 hour) of a consumer is assumed to be 10 m3/person with a body weight of 70 kg the corrected NOAEL(oral) is therefore: = 85 mg/m3*10 m3/70 kg = 12.1mg/kg bw/day
AF for dose response relationship:
1
Justification:
N/A based on OEL
AF for differences in duration of exposure:
1
Justification:
N/A based on OEL
AF for interspecies differences (allometric scaling):
1
Justification:
N/A based on OEL
AF for other interspecies differences:
1
Justification:
N/A based on OEL
AF for intraspecies differences:
2
Justification:
Assessment factor for difference in susceptibility of consumers compared with workers, assuming that the OEL already incorporates an assessment factor of 5 for workers
AF for the quality of the whole database:
1
Justification:
N/A based on OEL
AF for remaining uncertainties:
1
Justification:
N/A based on OEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: Based on inhalation OEL for tetraethyl orthosilicate
Overall assessment factor (AF):
2
DNEL extrapolated from long term DNEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population