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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 484-460-1 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.735 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance in combination with company/substance specific justifications
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 13.22 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEC = NOAEL of 15 mg/kg bw/day * 1/0,38 * 6,7/10 * 1/2 (= default factor of 2 for oral to inhalation extrapolation as no route specific information is available.
- AF for dose response relationship:
- 1
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 1 may be supported as a NOAEL was established in the study.
- AF for differences in duration of exposure:
- 6
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 6 may be used for duration extrapolation (i.e., subacute to chronic).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No interspecies differences are to be taken into account for an inhalation DNEL
- AF for other interspecies differences:
- 1
- Justification:
- No interspecies differences are to be taken into account for an inhalation DNEL
- AF for intraspecies differences:
- 3
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 3 may be supported by data from similar compounds. Toxicological evaluation of other structurally similar oxime silanes demonstrated similar toxicities whose severity did not increase with longer duration exposure and showed recoverability once compound exposure was stopped.
- AF for the quality of the whole database:
- 1
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 1 may be supported as the study is robust and the effects observed were similar to those observed in studies conducted with other structurally similar oxime silanes following acute or repeated exposure by oral and inhalation routes of exposure.
- AF for remaining uncertainties:
- 1
- Justification:
- No AF for remaining uncertainties deemed necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.205 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- 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:
- 0.208 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance in combination with company/substance specific justifications
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dose descriptor starting value for the dermal DNEL is equal to the one determined in the oral study as (in the absence of toxicokinetics information) it can be assumed that dermal absorption will not be higher than oral absorption.
- AF for dose response relationship:
- 1
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 1 may be supported as a NOAEL was established in the study.
- AF for differences in duration of exposure:
- 6
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 6 may be used for duration extrapolation (i.e., subacute to chronic).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- According to REACH guidance 8.4.3.1, a factor of 4 is appropriate for allometric scaling between rats and humans.
- AF for other interspecies differences:
- 1
- Justification:
- No AF for additional differences was identified.
- AF for intraspecies differences:
- 3
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 3 may be supported by data from similar compounds. Toxicological evaluation of other structurally similar oxime silanes demonstrated similar toxicities whose severity did not increase with longer duration exposure and showed recoverability once compound exposure was stopped.
- AF for the quality of the whole database:
- 1
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 1 may be supported as the study is robust and the effects observed were similar to those observed in studies conducted with other structurally similar oxime silanes following acute or repeated exposure by oral and inhalation routes of exposure.
- AF for remaining uncertainties:
- 1
- Justification:
- No AF for remaining uncertainties deemed necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.624 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- 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:
- medium hazard (no threshold derived)
Additional information - workers
According to the REACH "Guidance on information requirements and chemical safety assessment", a leading DN(M)EL needs to be derived for every relevant human population and every relevant route, duration and frequency of exposure, if feasible.
As there is only a repeated dose study available for the oral route of exposure all DNELs have been derived using the NOAEL of that study as starting point.
Oral short term:
Short-term – oral, systemic effects. The REACH guidance states that the most relevant DNELacutefor workers and the general population is by inhalation. However, inhalation data for OS-1600 (or MPKO, the major hydrolysis product of OS-1600) is not available. Due to the limited data set (acute oral LD50) and the high level of uncertainty introduced by route-to-route extrapolation, the oral DNELacutewas based on the highest oral DNELlong term. An assessment factor of 3 was used, based on the GHS classification for acute toxicity (Category 4) for this material.
DNELacute= (DNELlong term) x 3 = 0.21 mg/kg bw/day x 3 = 0.63 mg/kg bw
Oral long term:
Long-term – oral, systemic effects. The DNELlong term was derived from the 28 -day repeat dose toxicity study of MPKO, the major hydrolysis product of OS-1600, in rats that was conducted with multiple dose levels and included evaluation of several endpoints.
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: |
MPKO affected the red blood cells, spleen weight and macroscopic appearance at dose levels of 50 mg/kg bw/day and above and hemosiderosis was seen at dose levels of 15 mg/kg bw/day and above with indicators of congestion and extramedullary hemopoisis at higher doses. The effects observed at 15 mg/kg bw/day were not considered adverse. |
Step 2) Modification of starting point |
- |
None needed |
Step 3) Assessment factors |
||
Interspecies |
4 |
According to REACH guidance 8.4.3.1, a factor of 4 is appropriate for allometric scaling between rats and humans. |
Intraspecies |
3 |
As per REACH guidance 8.4.3.1, a factor of 3 may be supported by data from similar compounds. Toxicological evaluation of other structurally similar oxime silanes demonstrated similar toxicities whose severity did not increase with longer duration exposure and showed recoverability once compound exposure was stopped. |
Exposure duration |
6 |
As per REACH guidance 8.4.3.1, a factor of 6 may be used for duration extrapolation (i.e., subacute to chronic). |
Dose response |
1 |
As per REACH guidance 8.4.3.1, a factor of 1 may be supported as a NOAEL was established in the study. |
Quality of database |
1 |
As per REACH guidance 8.4.3.1, a factor of 1 may be supported as the study is robust and the effects observed were similar to those observed in studies conducted with other structurally similar oxime silanes following acute or repeated exposure by oral and inhalation routes of exposure. |
DNELLong Term |
Value |
|
15 / (72) = 0.21 mg/kg bw/day |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.217 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance in combination with company/substance specific justifications
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 6.52 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEC = NOAEL of 15 mg/kg bw/day * 1/1,15 * 1/2 (= default factor of 2 for oral to inhalation extrapolation as no route specific information is available.
- AF for dose response relationship:
- 1
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 1 may be supported as a NOAEL was established in the study.
- AF for differences in duration of exposure:
- 6
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 6 may be used for duration extrapolation (i.e., subacute to chronic).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No interspecies differences are to be taken into account for an inhalation DNEL
- AF for other interspecies differences:
- 1
- Justification:
- No interspecies differences are to be taken into account for an inhalation DNEL
- AF for intraspecies differences:
- 5
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 5 may be supported by data from similar compounds. Toxicological evaluation of other structurally similar oxime silanes demonstrated similar toxicities whose severity did not increase with longer duration exposure and showed recoverability once compound exposure was stopped.
- AF for the quality of the whole database:
- 1
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 1 may be supported as the study is robust and the effects observed were similar to those observed in studies conducted with other structurally similar oxime silanes following acute or repeated exposure by oral and inhalation routes of exposure.
- AF for remaining uncertainties:
- 1
- Justification:
- No AF for remaining uncertainties deemed necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.651 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- 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:
- 0.125 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance in combination with company/substance specific justifications
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dose descriptor starting value for the dermal DNEL is equal to the one determined in the oral study as (in the absence of toxicokinetics information) it can be assumed that dermal absorption will not be higher than oral absorption.
- AF for dose response relationship:
- 1
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 1 may be supported as a NOAEL was established in the study.
- AF for differences in duration of exposure:
- 6
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 6 may be used for duration extrapolation (i.e., subacute to chronic).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- According to REACH guidance 8.4.3.1, a factor of 4 is appropriate for allometric scaling between rats and humans.
- AF for other interspecies differences:
- 5
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 5 may be supported by data from similar compounds. Toxicological evaluation of other structurally similar oxime silanes demonstrated similar toxicities whose severity did not increase with longer duration exposure and showed recoverability once compound exposure was stopped.
- AF for intraspecies differences:
- 1
- Justification:
- No AF for additional differences was identified.
- AF for the quality of the whole database:
- 1
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 1 may be supported as the study is robust and the effects observed were similar to those observed in studies conducted with other structurally similar oxime silanes following acute or repeated exposure by oral and inhalation routes of exposure.
- AF for remaining uncertainties:
- 1
- Justification:
- No AF for remaining uncertainties deemed necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.375 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- 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:
- 0.125 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):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No justification required as there is no route to route extrapolation required (starting value is oral study).
- AF for dose response relationship:
- 1
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 1 may be supported as a NOAEL was established in the study.
- AF for differences in duration of exposure:
- 6
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 6 may be used for duration extrapolation (i.e., subacute to chronic).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- According to REACH guidance 8.4.3.1, a factor of 4 is appropriate for allometric scaling between rats and humans.
- AF for other interspecies differences:
- 1
- Justification:
- No AF for additional differences was identified.
- AF for intraspecies differences:
- 5
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 5 may be supported by data from similar compounds. Toxicological evaluation of other structurally similar oxime silanes demonstrated similar toxicities whose severity did not increase with longer duration exposure and showed recoverability once compound exposure was stopped.
- AF for the quality of the whole database:
- 1
- Justification:
- As per REACH guidance 8.4.3.1, a factor of 1 may be supported as the study is robust and the effects observed were similar to those observed in studies conducted with other structurally similar oxime silanes following acute or repeated exposure by oral and inhalation routes of exposure.
- AF for remaining uncertainties:
- 1
- Justification:
- No AF for remaining uncertainties deemed necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.375 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
As there is only a repeated dose study available for the oral route of exposure, all DNELs have been derived using the NOAEL of that study as starting point.
Oral short term:
Short-term – oral, systemic effects. The REACH guidance states that the most relevant DNELacutefor workers and the general population is by inhalation. However, inhalation data for OS-1600 (or MPKO, the major hydrolysis product of OS-1600) is not available. Due to the limited data set (acute oral LD50) and the high level of uncertainty introduced by route-to-route extrapolation, the oral DNELacutewas based on the highest oral DNELlong term. An assessment factor of 3 was used, based on the GHS classification for acute toxicity (Category 4) for this material.
DNELacute= (DNELlong term) x 3 = 0.125 mg/kg bw/day x 3 = 0.375 mg/kg bw
Oral long term:
Long-term – oral, systemic effects. The DNELLong Term was derived from the 28-day repeat dose toxicity study of MPKO, the major hydrolysis product of OS-1600, in rats that was conducted with multiple dose levels and included evaluation of several endpoints.
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: |
MPKO affected the red blood cells, spleen weight and macroscopic appearance at dose levels of 50 mg/kg bw/day and above and hemosiderosis was seen at dose levels of 15 mg/kg bw/day and above with indicators of congestion and extramedullary hemopoisis at higher doses. The effects observed at 15 mg/kg bw/day were not considered adverse. |
Step 2) Modification of starting point |
- |
None needed |
Step 3) Assessment factors |
||
Interspecies |
4 |
According to REACH guidance 8.4.3.1, a factor of 4 is appropriate for allometric scaling between rats and humans. |
Intraspecies |
5 |
As per REACH guidance 8.4.3.1, a factor of 5 may be supported by data from similar compounds. Toxicological evaluation of other structurally similar oxime silanes demonstrated similar toxicities whose severity did not increase with longer duration exposure and showed recoverability once compound exposure was stopped. |
Exposure duration |
6 |
As per REACH guidance 8.4.3.1, a factor of 6 may be used for duration extrapolation (i.e., subacute to chronic). |
Dose response |
1 |
As per REACH guidance 8.4.3.1, a factor of 1 may be supported as a NOAEL was established in the study. |
Quality of database |
1 |
As per REACH guidance 8.4.3.1, a factor of 1 may be supported as the study is robust and the effects observed were similar to those observed in studies conducted with other structurally similar oxime silanes following acute or repeated exposure by oral and inhalation routes of exposure. |
DNELLong Term |
Value |
|
15 / (120) = 0.125 mg/kg bw/day |
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