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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
16.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEC
Value:
813 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
409 mg/m³
Explanation for the modification of the dose descriptor starting point:

The interim DNEL for systemic effects via the inhalation route is determined on the basis of route-to-route extrapolation from the inhalation 90-day NOAEC derived for the source substance, (3-chloropropyl)trimethoxysilane (813 mg/m³). The following corrections were made: Correction for experimental exposure duration (6 h/d to 8 h/d): 6/8 (ECHA default). Correction for respiratory volume (worker): 6.7 m³/d/10 m³/d (ECHA default) Therefore, the corrected NOAEC is: 813*(6 h/ 8 h)*(6.7 m³/day/10 m³/day) = 409 mg/m³.

AF for dose response relationship:
1
Justification:
A clear NOAEC has been determined
AF for differences in duration of exposure:
2
Justification:
Default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (inhaled rat to inhaled human)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
The available studies were conducted according to relevant OECD test guidelines and in compliance with GLP.
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:
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:
2.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
Value:
813 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
231.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The interim DNEL for systemic effects via the dermal route is determined on the basis of route-to-route extrapolation from the inhalation NOAEC for the source substance, (3-chloropropyl)trimethoxysilane (813 mg/m3) from the 90-day study in rats.

The following correction was made to the NOAEC (inhaled): Correction respiratory volume rat (8 hour) = 0.38 m³/kg bw. Correction for duration: 6 hours/8 hours. Therefore, the corrected NOAEL is: 813*0.38*(6/8) = 231.7 mg/kg bw/day

AF for dose response relationship:
1
Justification:
A clear NOAEL has been determined
AF for differences in duration of exposure:
2
Justification:
Default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (inhaled rat to dermal human)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
The available studies were conducted according to relevant OECD test guidelines and in compliance with GLP.
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:
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:
2.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEC
Value:
813 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
145 mg/m³
Explanation for the modification of the dose descriptor starting point:

The interim DNEL for systemic effects via the inhalation route is determined on the basis of the 90-day inhalation NOAEC for the source substance, (3-chloropropyl)trimethoxysilane (813 mg/m³). The following corrections were made: Correction for experimental exposure duration (6 h/d to 24 h/d): 6/24 (ECHA default). Correction for dosing frequency: 5 days/7 days. Therefore, the corrected NOAEC is: 813*(6 h/ 24 h)*(5 days/7 days) = 145 mg/m³.

AF for dose response relationship:
1
Justification:
A clear NOAEL has been determined
AF for differences in duration of exposure:
2
Justification:
Default (subchronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (rat inhaled to human inhaled)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default (general population)
AF for the quality of the whole database:
1
Justification:
The available studies were conducted according to relevant OECD test guidelines and in compliance with GLP.
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:
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:
3.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEC
Value:
813 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
667.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The interim DNEL for systemic effects via the dermal route is determined on the basis of the 90-day inhalation NOAEC for the source substance, (3-chloropropyl)trimethoxysilane (813 mg/m³).

The following corrections were made: Correction respiratory volume rat (24 hour) = 1.15 m³/kg bw. Correction for dosing frequency: 5 days/7 days. Therefore, the corrected NOAEL is: 813*1.15*(5 days/7 days) = 667.8 mg/kg bw/day.
AF for dose response relationship:
1
Justification:
A clear NOAEC has been established.
AF for differences in duration of exposure:
2
Justification:
Default (subchronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (inhaled rat to dermal human)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
Default (general population)
AF for the quality of the whole database:
1
Justification:
The available studies were conducted according to relevant OECD test guidelines and in compliance with GLP.
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:
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:
3.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEC
Value:
813 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
667.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The interim DNEL for systemic effects via the oral route is determined on the basis of route-to-route extrapolation from the inhalation NOAEC for the source substance, (3-chloropropyl)trimethoxysilane (813 mg/m3) from the 90-day study in rats.

The following corrections were made to the NOAEC (inhaled): Correction respiratory volume rat (24 hour) = 1.15 m³/kg bw. Correction for dosing frequency: 5 days/7 days. Therefore, the corrected NOAEL is: 813*1.15*(5/7) = 667.8 mg/kg/day.

AF for dose response relationship:
1
Justification:
A clear NOAEC has been established
AF for differences in duration of exposure:
2
Justification:
Default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (inhaled rat to oral human)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA defaulth
AF for the quality of the whole database:
1
Justification:
The available studies are conducted according to relevant guidelines and in compliance with GLP
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