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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 DNEL for systemic effects via the inhalation route is based on results from the inhalation OECD 413 study with 3-chloropropyl(trimethoxy)silane. In this study a NOAEC of at least 100 ppm as no adverse treatment-related effects were observed up to the highest concentration tested.  NOAEC ≥100 ppm (≥813 mg/m3 based on a molecular weight of 198.72). The following correction was made to the NOAEC:  Modification for experimental exposure duration (6 h in study to 8 h in workers): 0.75;  Modification for respiratory volume (rat to human): 6.7/10.  Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: [≥813 mg/m3*(6.7/10)*(0.75)] ≥ 409 mg/m3.

AF for dose response relationship:
1
Justification:
A clear NOAEC was established
AF for differences in duration of exposure:
2
Justification:
Default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (inhalation route)
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Guideline, GLP study
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:
232 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The DNEL for systemic effects via the dermal route is determined on the basis of route-to-route extrapolation from the inhalation OECD 413 study with 3-chloropropyl(trimethoxy)silane. In this study a NOAEC of at least 100 ppm was derived, as no adverse treatment-related effects were observed up to the highest concentration tested.  NOAEC ≥100 ppm (≥813 mg/m3 based on a molecular weight of 198.72). The following correction was made to the NOAEC:  Modification for exposure duration: 6 h/8 h. Modification for respiratory volume: 0.38 m3/kg. The corrected NOAEL(dermal) is therefore: (≥ 813 mg/m3*(6/8)*0.38 m3/kg) ≥ 232 mg/kg bw/day

AF for dose response relationship:
1
Justification:
A clear NOAEL was established
AF for differences in duration of exposure:
2
Justification:
Default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Guideline, GLP study
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

Short-term high exposures are considered to be unlikely given the high levels of control in place at sites producing and using the substance (see exposure section). DNELs for long-term exposure are therefore adequate to protect against short-term exposures and no separate short-term DNELs are calculated. Although no adverse systemic effects were seen in repeated-dose studies with the read-across substance, mortalities and clinical findings were observed in the acute oral toxicity studies with both the registered substance and the read-across substance. While uptake by the inhalation route is likely to be lower than by the oral route, as a precautionary measure long-term DNELs are calculated from the repeated dose inhalation study for risk characterisation purposes.

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:
145.18 mg/m³
Explanation for the modification of the dose descriptor starting point:

The DNEL for systemic effects via the inhalation route is based on results from the inhalation OECD 413 study with 3-chloropropyl(trimethoxy)silane. In this study a NOAEC of at least 100 ppm as no adverse treatment-related effects were observed up to the highest concentration tested.  NOAEC ≥100 ppm (≥813 mg/m3 based on a molecular weight of 198.72). The following correction was made to the NOAEC:  Modification for experimental exposure duration (6 h in study to 24 h for general population): 0.25 hours;  Correction for dosing frequency: 5 days/7 days: 5/7 days.  Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: [≥813 mg/m3*(0.25 hours)*5/7 days] ≥ 145.18 mg/m3.

AF for dose response relationship:
1
Justification:
A clear NOAEC was established
AF for differences in duration of exposure:
2
Justification:
Default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (inhalation route)
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Guideline, GLP study
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:
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:
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
Modified dose descriptor starting point:
NOAEL
Value:
668 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The DNEL for systemic effects via the oral route is determined on the basis of route-to-route extrapolation from the inhalation OECD 413 study with 3-chloropropyl(trimethoxy)silane. In this study a NOAEC of at least 100 ppm was derived, as no adverse treatment-related effects were observed up to the highest concentration tested. NOAEC ≥100 ppm (≥813 mg/m3 based on a molecular weight of 198.72). Modification for number of exposures per week (5 in study to 7 in human consumers): 5/7.  Correction for respiratory volume: 1.15 m3/kg. The corrected NOAEL(oral) is therefore: (≥813 mg/m3*5/7*1.15 m3/kg) ≥668 mg/kg bw/day

AF for dose response relationship:
1
Justification:
A clear NOAEC was established
AF for differences in duration of exposure:
2
Justification:
Default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default for allometric scaling
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.84 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
DNEL extrapolated from long term DNEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

There are no consumer uses of 3-chloropropyl(dimethoxy)methylsilane therefore DNELs for the dermal and inhalation routes are not required for consumers. An oral DNEL is presented for the purposes of assessment of man exposed via the environment.