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EC number: 289-390-3 | CAS number: 88127-84-8
- 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:
- 8.82 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The toxicity of 9-[2-(2-METHOXYETHOXY)ETHOXY]-9-[3(OXIRANYLMETHOXY)PROPYL]-2,5,8,10,13,16-HEXAOXA-9-SILAHEPTADECANE was investigated the systemic toxicity and potential adverse effects of the test item on reproduction (including offspring development) and was designed to be compatible with the requirements of the OECD Guidelines for Testing of Chemicals No. 422 “Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test” (adopted 22 March 1996).
This study was also designed to be compatible with Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 1000 mg/kg bw/day.
The ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 1000 mg/kg bw/day.
Since only a sub-chronic oral toxicity study is available a route-to-route extrapolation is needed to derive the DNELs for dermal and inhalation routes. According to Chapter R.8 of REACH Guidance on information requirements and chemical safety assessment, it is proposed in the absence of route specific information on the starting route, to include a default factor of 2 in the case of oral-inhalation extrapolation. On the assumption, that in general, dermal absorption will not be higher than oral absorption, no default factor is introduced for the oral to dermal extrapolation. The REACH Guidance on information requirements and chemical safety assessment (R.8.4.2) prescribes a default factor of 1 in case of oral to dermal extrapolation. This approach will be taken forward to DNEL derivation.
- AF for differences in duration of exposure:
- 2
- Justification:
- Assessment factor of two included due to extrapolation from a sub-chronic to chronic endpoint
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- Default, to correct for differences in metabolic rate (allometric scaling) and to apply an additional factor of 2.5 for other interspecies differences, i.e. toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part). As described in R.8.4.3.1 Assessment factors relating to the extrapolation procedure of the REACH Guidance
- AF for other interspecies differences:
- 5
- Justification:
- For workers, as standard procedure for threshold effects a default assessment factor of 5 is to be used, based on the fact that this sub population does not cover the very young, the very old, and the very ill.
- AF for intraspecies differences:
- 4
- Justification:
- Assuming body weight of rat 0.250 kg an allometric scaling factor of 4 is applied based on the assumed Human weight of 70 kg (as detailed in Table R8-3 of REACH Guidance on information requirements and chemical safety assessment)
- Justification:
- The database is considered to be of good and there is no need to include an assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 35.3 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The acute oral toxicity to the rat was assessed based on the OECD 420 Acute Oral Toxicity-Fixed dose method, Animals were dosed at 2000 mg/kg bw d and no mortalities occurred therefore the LD50 was determined to be >2000 mg/kg bw/d. Due to a lack of effects ay this dose has been used to derive DNEL values for acute/short term exposure.
An toxicity study by the inhalation is not available so a route-to-route extrapolation is needed to derive the DNELs for dermal and inhalation routes. According to Chapter R.8 of REACH Guidance on information requirements and chemical safety assessment, it is proposed in the absence of route specific information on the starting route, to include a default factor of 2 in the case of oral-inhalation extrapolation.
2000/2 (absorption rate) / 0.38 m3/kg bw = Inhalation NOAEL Rat of 2631.5 mg/m3 (8h)
2631.5 x 0.67 = 1763.2 mg/m3
Assessment factor for dose response is not required, the NOAEL from an acute study has been used for derivation of the DNEL/NOAEC. The acute laboratory endpoint is considered to reflect the most appropriate endpoint for assessing acute risk.
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- Default, to correct for differences in metabolic rate (allometric scaling) and to apply an additional factor of 2.5 for other interspecies differences, i.e. toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part). As described in R.8.4.3.1 Assessment factors relating to the extrapolation procedure of the REACH Guidance
- AF for other interspecies differences:
- 4
- Justification:
- Assuming body weight of rat 0.250 kg an allometric scaling factor of 4 is applied based on the assumed Human weight of 70 kg (as detailed in Table R8-3 of REACH Guidance on information requirements and chemical safety assessment)
- AF for intraspecies differences:
- 5
- Justification:
- For workers, as standard procedure for threshold effects a default assessment factor of 5 is to be used, based on the fact that this sub population does not cover the very young, the very old, and the very ill.
- Justification:
- The database is considered to be of good and there is no need to include an assessment factor.
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The acute dermal LD50 9-[2-(2-METHOXYETHOXY)ETHOXY]-9-[3(OXIRANYLMETHOXY)PROPYL]-2,5,8,10,13,16-HEXAOXA-9-SILAHEPTADECANE in rats of both sexes observed in a OECD 402 Acute Dermal study and determined to be greater than 2000 mg/kg, The test material has therefore practically no acute toxicity to the rat by this route of application. Skin irritation was also not observed. As a long term dermal toxicity study is not available the oral reproductive toxicity endpoint determined using a the OECD Guidelines for Testing of Chemicals No. 422 “Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening test design will be used for assessment purposes. The NOAEL was determined to be 1000 mg/kg bw day, this was also the maximum tested dose.
On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor is introduced for the oral to dermal extrapolation. The REACH Guidance on information requirements and chemical safety assessment (R.8.4.2) prescribes a default factor of 1 in case of oral to dermal extrapolation. However, based on the log Kow of <0.507 and molecular weight of the substance (500.65), the skin permeability according to Fitzpatrick et al (2004) of the substance is considered to be marginally permeable to the skin based on a calculated Log skin permeation coefficient of -7.38. Therefore, a ratio of 0.5 for oral to dermal absorption is provisonally suggested for DNEL derivation.
Modified dose descriptor (dermal) = 1000/0.5 (skin absorption rate for slightly permeable substance) = 2000 mg/kg bw
- AF for dose response relationship:
- 2
- Justification:
- Assessment factor of two included due to extrapolation from a sub-chronic to chronic endpoint
- AF for differences in duration of exposure:
- 2.5
- Justification:
- Default, to correct for differences in metabolic rate (allometric scaling) and to apply an additional factor of 2.5 for other interspecies differences, i.e. toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part). As described in R.8.4.3.1 Assessment factors relating to the extrapolation procedure of the REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Assuming body weight of rat 0.250 kg an allometric scaling factor of 4 is applied based on the assumed Human weight of 70 kg (as detailed in Table R8-3 of REACH Guidance on information requirements and chemical safety assessment)
- AF for other interspecies differences:
- 5
- Justification:
- For workers, as standard procedure for threshold effects a default assessment factor of 5 is to be used, based on the fact that this sub population does not cover the very young, the very old, and the very ill.
- Justification:
- The database is considered to be of good and there is no need to include an assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The acute dermal LD50 9-[2-(2-METHOXYETHOXY)ETHOXY]-9-[3(OXIRANYLMETHOXY)PROPYL]-2,5,8,10,13,16-HEXAOXA-9-SILAHEPTADECANE in rats of both sexes observed in an OECD 402 Acute Dermal study and determined to be greater than 2000 mg/kg, The test material has therefore practically no acute toxicity to the rat by this route of application. Skin irritation was also not observed in Dermal irritation, Episkin irritation, Epiderm corrrosion studies.
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
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.
Short-term toxicity:
The acute oral toxicity to the rat was assessed based on the OECD 420 Acute Oral Toxicity-Fixed dose method, Animals were dosed at 2000 mg/kg bw d and no mortalities occurred therefore the LD50 was determined to be >2000 mg/kg bw/d. Due to a lack of effects ay this dose has been used to derive DNEL values for acute/short term exposure.
The acute dermal LD50 9-[2-(2-METHOXYETHOXY)ETHOXY]-9-[3(OXIRANYLMETHOXY)PROPYL]-2,5,8,10,13,16-HEXAOXA-9-SILAHEPTADECANE in rats of both sexes observed in anOECD 402 Acute Dermal study and determined to be greater than 2000 mg/kg, The test material has therefore practically no acute toxicity to the rat by this route of application. Skin irritation was also not observed in Dermal irritation, Episkin irritation, Epiderm corrrosion studies and sensitization was not apparent in an LLNA study.
No particular hazards were identified
Long-term toxicity:
The toxicity of 9-[2-(2-METHOXYETHOXY)ETHOXY]-9-[3(OXIRANYLMETHOXY)PROPYL]-2,5,8,10,13,16-HEXAOXA-9-SILAHEPTADECANE was investigated the systemic toxicity and potential adverse effects of the test item on reproduction (including offspring development) and was designed to be compatible with the requirements of the OECD Guidelines for Testing of Chemicals No. 422 “Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test” (adopted 22 March 1996). This study was also designed to be compatible with Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 1000 mg/kg bw/day. The ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 1000 mg/kg bw/day.
Since only a sub-chronic toxicity study is available a route-to-route extrapolation is needed to derive the DNELs for dermal and inhalation route. According to Chapter R.8 of REACH Guidance on information requirements and chemical safety assessment, it is
proposed in the absence of route-specific information on the starting route, to include a default factor of 2 in the case of oral-to-inhalation extrapolation. On the assumption that, in general, dermal absorption will not be higher than oral absorption, The REACH Guidance on information requirements and chemical safety assessment (R.8.4.2) prescribes a default factor of 1 in case of oral to dermal extrapolation. However, based on the log Kow of <0.507and molecular weight of the substance (500.65), the skin permeability according to Fitzpatrick et al (2004) of the substance is considered to be marginally permeable to the skin. Therefore, a ratio of 0.5 for oral to dermal absorption is provisonally suggested for DNEL derivation
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not intended to be marketed for consumer use.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not intended to be marketed for consumer use.
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
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not intended to be marketed for consumer use.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not intended to be marketed for consumer use.
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:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not intended to be marketed for consumer use.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not intended to be marketed for consumer use.
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The substance is not intended to be marketed for consumer use.
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.