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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
27.6 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):
11
Dose descriptor starting point:
NOAEC
Value:
605 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
304.01 mg/m³
Explanation for the modification of the dose descriptor starting point:

The following correction was made to the NOAEC (inhalation): Correction for experimental exposure duration (6 h/d to 8 h/d), Correction for respiratory volume (worker): 6.7 m3/10 m3. Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 605*(6 h/ 8 h) *(6.7 m3/10 m3) = 304.01 mg/m3.

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
2
Justification:
Default
AF for interspecies differences (allometric scaling):
1
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
2.2
Justification:
Substance-specific assessment factor (see section 7.1 on Toxicokinetics, metabolism and distribution)
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:
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:
3.9 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):
44
Dose descriptor starting point:
NOAEC
Value:
605 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
172.43 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

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. (or relevant exposure period from study/8 hour working day). Therefore, the corrected NOAEL for repeat-dose systemic effects via the dermal route is: inhaled 605*0.38*(6/8) = 172.43 mg/kg bw/day

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
2
Justification:
Default
AF for interspecies differences (allometric scaling):
4
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
2.2
Justification:
Substance-specific assessment factor (see section 7.1 on Toxicokinetics, metabolism and distribution)
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:
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

Currently, there is an ongoing OECD 443 test. Once this test is completed the DNELs for trimethoxy(vinyl)silane will be updated in line with new toxicity test results, using appropriate assessment factors.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
18.9 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):
8
Dose descriptor starting point:
NOAEC
Value:
605 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
151.25 mg/m³
Explanation for the modification of the dose descriptor starting point:

DNEL for infrequent inhalation exposures

Correction for exposure duration (6h/24h) was applied, but no correction for number of exposures (5d/7d) was made as infrequent exposure is expected. Therefore, 605*(6/24) = 151.25 mg/m³

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Default for infrequent exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
3.2
Justification:
Substance-specific assessment factor (see section 7.1 on Toxicokinetics, metabolism and distribution)
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:
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
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:
7.8 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):
64
Dose descriptor starting point:
NOAEC
Value:
605
Modified dose descriptor starting point:
NOAEL
Value:
496.96 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The following correction was 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 for repeat-dose systemic effects via the oral route is: inhaled 605*1.15*(5/7) = 496.96 mg/kg bw/day

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
2
Justification:
Default
AF for interspecies differences (allometric scaling):
4
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
3.2
Justification:
Substance-specific assessment factor (see section 7.1 on Toxicokinetics, metabolism and distribution)
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:
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:
0.3 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):
192
Dose descriptor starting point:
NOAEL
Value:
62.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
62.5 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
6
Justification:
Default
AF for interspecies differences (allometric scaling):
4
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
3.2
Justification:
Substance-specific assessment factor (see section 7.1 on Toxicokinetics, metabolism and distribution)
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:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Currently, there is an ongoing OECD 443 test. Once this test is completed the DNELs for trimethoxy(vinyl)silane will be updated in line with new toxicity test results, using appropriate assessment factors.