Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
nonapotassium 2,4,6-trihydroxy-4-methyl-3,5-dioxa-2,4,6-trisilaheptane-2,6-bis(olate) 2,6,8-trihydroxy-4,6-dimethyl-3,5,7-trioxa-2,4,6,8-tetrasilanonane-2,4,8-tris(olate) 6-hydroxy-2,4,6-trimethyl-1,3,5,2,4,6-trioxatrisilinane-2,4-bis(olate) dihydroxy(methyl)silanolate {[dihydroxy(methyl)silyl]oxy}(hydroxy)methylsilanolate
EC number: 935-877-7 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 47 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 6
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 280 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The DNEL for systemic effects via the inhalation route is determined on the basis of read-across of the 90-day inhalation NOAEC for trimethoxy(methyl) silane (557 mg/m³). No correction for molecular weight is applied for read-across. 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/day/10 m³/day (ECHA default). Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 557*(6 h/ 8 h) *(6.7 m³/day/10 m³/day) =280 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA default (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- DNEL is based on inhalation study
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC default
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC default
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECETOC default
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 47 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 6
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 280 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The DNEL for systemic effects via the inhalation route is determined on the basis of read-across of the 90-day inhalation NOAEC for trimethoxy(methyl) silane (557 mg/m³). No correction for molecular weight is applied for read-across. 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/day/10 m³/day (ECHA default). Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 557*(6 h/ 8 h) *(6.7 m³/day/10 m³/day) =280 mg/m³.
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 158.7 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 NOAEC for trimethoxy(methyl) silane (557 mg/m³) from the 90-day study in rats. No correction for molecular weight is applied for read-across. The following corrections were made: correction for exposure duration: 6 h/8 h (ECHA default for workers), correction for respiratory volume: 0.38 m³/kg (ECHA default, rat, 8 hour). The corrected NOAEL(dermal) is therefore: (557*(6 h/8 h) *0.38 m³/kg) = 158.7 mg/kg/day
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA default (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default (rat to human)
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC default
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC default
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECETOC default
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 158.7 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 NOAEC for trimethoxy(methyl) silane (557 mg/m³) from the 90-day study in rats. No correction for molecular weight is applied for read-across. The following corrections were made: correction for exposure duration: 6 h/8 h (ECHA default for workers), correction for respiratory volume: 0.38 m³/kg (ECHA default, rat, 8 hour). The corrected NOAEL(dermal) is therefore: (557*(6 h/8 h) *0.38 m³/kg) = 158.7 mg/kg/day
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
Dermal route
The DNEL for systemic effects via the dermal route is determined on the basis of route-to-route extrapolation from the inhalation NOAEC for trimethoxy(methyl)silane (557 mg/m3) from the 90-day study in rats.
No correction for molecular weight is applied for read-across. The following corrections were made:
Correction for experimental exposure duration: 6 h/8 h (ECHA default for workers)
Correction for respiratory volume: 0.38 m3/kg (ECHA default, rat, 8 hour)
The corrected NOAEL(dermal) is therefore: (557*(6 h/8 h)*0.38 m3/kg) = 158.7 mg/kg bw/day
The following assessment factors were applied to the corrected NOAEL:
Assessment factor for route to route extrapolation (inhalation to dermal): 1 (ECHA default)
Assessment factor for allometric scaling (rat to human): 4 (ECHA default)
Assessment factor for extrapolation of exposure duration (sub-chronic to chronic): 2 (ECHA default)Assessment factor for interspecies differences (systemic): 1 (ECETOC default)
Assessment factor for intraspecies differences (systemic): 3 (ECETOC default)
The overall DNEL (repeated-dose – systemic – dermal) is therefore 158.7/(1*4*2*1*3) =6.6 mg/kg bw/day
Inhalation route
The DNEL for systemic effects via the inhalation route is determined on the basis of read-across of the 90-day inhalation NOAEC for trimethoxy(methyl)silane (557 mg/m3).
No correction for molecular weight is applied for read-across. 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/day/10 m3/day (ECHA default)
Therefore the corrected NOAEC for repeated-dose local effects via the inhalation route is:
557*(6 h/ 8 h)*(6.7 m3/day/10 m3/day) = 280 mg/m3.
The assessment factors used to determine the DNEL (inhalation) were selected on the following basis:
Assessment factor for extrapolation of exposure duration (sub-chronic to chronic): 2 (ECHA default)
Assessment factor for interspecies differences: 1 (ECECTOC default)
Assessment factor for intraspecies differences: 3 (ECETOC default)
The overall DNEL (repeated-dose – systemic – inhalation) is therefore: 280 mg/m3/(2*1*3)= 47 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 99.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The DNEL for systemic effects via the inhalation route is determined on the basis of read-across of the 90-day inhalation NOAEC for trimethoxy(methyl) silane (557 mg/m³). No correction for molecular weight is applied for read-across. The following corrections were made: correction for experimental exposure duration (6 h/d to 24 h/d): 6/24 (ECHA default), correction for number of exposures per week: 5 d/7 d (study data). Therefore the corrected NOAEC for repeated-dose local effects via the inhalation route is: 557*(6 h/ 24 h) *(5 d/7 d) =99.5 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA default (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- DNEL is based on inhalation study
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC default
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC default
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECETOC default
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 99.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The DNEL for systemic effects via the inhalation route is determined on the basis of read-across of the 90-day inhalation NOAEC for trimethoxy(methyl) silane (557 mg/m³). No correction for molecular weight is applied for read-across. The following corrections were made: correction for experimental exposure duration (6 h/d to 24 h/d): 6/24 (ECHA default), correction for number of exposures per week: 5 d/7 d (study data). Therefore the corrected NOAEC for repeated-dose local effects via the inhalation route is: 557*(6 h/ 24 h) *(5 d/7 d) =99.5 mg/m³.
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.9 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 114.4 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 NOAEC for trimethoxy(methyl)silane (557 mg/m³) from the 90-day study in rats. No correction for molecular weight is applied for read-across. The following corrections were made: correction for exposure duration: 6 h/24 h (ECHA default for consumers), correction for number of exposures per week: 5/7 (study data), correction for respiratory volume: 1.15 m³/kg (ECHA default, rat, 24 hour). The corrected NOAEL(dermal) is therefore: (560*(6 h/24 h)*(5/7)*1.15 m³/kg) = 114.4 mg/kg/day.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA default (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default (rat to human)
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC default
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC default
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECETOC default
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.9 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 114.4 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 NOAEC for trimethoxy(methyl)silane (557 mg/m³) from the 90-day study in rats. No correction for molecular weight is applied for read-across. The following corrections were made: correction for exposure duration: 6 h/24 h (ECHA default for consumers), correction for number of exposures per week: 5/7 (study data), correction for respiratory volume: 1.15 m³/kg (ECHA default, rat, 24 hour). The corrected NOAEL(dermal) is therefore: (560*(6 h/24 h)*(5/7)*1.15 m³/kg) = 114.4 mg/kg/day.
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.42 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 6
- Justification:
- There are insufficient data to determine whether effects are in/dependent of exposure duration, therefore an assessment factor for extrapolation of exposure duration (sub-acute to chronic) has been applied.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default (rat to human)
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC default
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC default
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECETOC default
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.42 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 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 the 28-day oral NOAEL for MTMS (50 mg/kg/day).
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
Dermal route
The DNEL for systemic effects via the dermal route is determined on the basis of route-to-route extrapolation from the inhalation NOAEC for trimethoxy(methyl)silane (557 mg/m3) from the 90-day study in rats.
No correction for molecular weight is applied for read-across. The following corrections were made:
Correction for exposure duration: 6 h/24 h (ECHA default for consumers)
Correction for number of exposures per week: 5/7 (study data)
Correction for respiratory volume: 1.15 m3/kg (ECHA default, rat, 24 hour)
The corrected NOAEL(dermal) is therefore: (557*(6 h/24 h)*(5/7)*1.15 m3/kg) = 114.4 mg/kg/day
The following assessment factors were applied to the corrected NOAEL:
Assessment factor for route to route extrapolation (inhalation to dermal): 1 (ECHA default)
Assessment factor for allometric scaling (rat to human): 4 (ECHA default)
Assessment factor for extrapolation of exposure duration (sub-chronic to chronic): 2 (ECHA default)Assessment factor for interspecies differences (systemic): 1 (ECETOC default)
Assessment factor for intraspecies differences (systemic): 5 (ECETOC default)
The overall DNEL (repeated-dose – systemic – dermal - consumer) is therefore 114.4/(1*4*2*1*5) = 2.9 mg/kg/day
Oral route
The DNEL for systemic effects via the oral route is determined on the basis of the 28-day oral NOAEL for MTMS (50 mg/kg/day).
The assessment factors used to determine the DNEL (oral) were selected on the following basis:
There are insufficient data to determine whether effects are in/dependent of exposure duration, therefore an assessment factor for extrapolation of exposure duration (sub-acute to chronic) has been applied.
Assessment factor for extrapolation of exposure duration (sub-acute to chronic): 6 (ECHA default)
Assessment factor for allometric scaling (rat to human): 4 (ECHA default)
Assessment factor for interspecies differences: 1 (ECECTOC default)
Assessment factor for intraspecies differences: 5 (ECETOC default)
The overall DNEL (repeated-dose – systemic – oral) is therefore: 50 mg/kg/day/(6*4*1*5)= 0.42 mg/kg/day
Inhalation route
The DNEL for systemic effects via the inhalation route is determined on the basis of read-across of the 90-day inhalation NOAEC for trimethoxy(methyl)silane (557 mg/m3).
No correction for molecular weight is applied for read-across. The following corrections were made:
Correction for experimental exposure duration (6 h/d to 24 h/d): 6/24 (ECHA default)
Correction for number of exposures per week: 5 d/7 d (study data)
Therefore the corrected NOAEC for repeated-dose local effects via the inhalation route is:
557*(6 h/ 24 h)*(5 d/7 d) =99.5 mg/m3.
The assessment factors used to determine the DNEL (inhalation) were selected on the following basis:
Assessment factor for extrapolation of exposure duration (sub-chronic to chronic): 2 (ECHA default)
Assessment factor for interspecies differences: 1 (ECECTOC default)
Assessment factor for intraspecies differences: 5 (ECETOC default)
The overall DNEL (repeated-dose – systemic – inhalation) is therefore: 99.5 mg/m3/(2*1*5)= 10 mg/m3
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
