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EC number: 219-842-7 | CAS number: 2550-02-9
- 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
Endpoint summary
Administrative data
Description of key information
There are no measured data on the skin sensitisation potential of
triethoxypropylsilane, therefore the structural analogue substance
trimethoxypropylsilane (CAS: 1067-25-0) has been used to assess its skin
sensitisation potential.
Buehler test according to OECD TG 406: not sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
To reduce animal testing REACH recommends to make use of a read-across approach where appropriate based on the high accordance in properties relevant for the specific endpoint. In the case of skin sensitisation relevant properties are structural similarity as well as physical-chemical and basic toxicological parameters in the same range.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Target: triethoxy(propyl)silane (2550-02-9)
Source: trimethoxy(propyl)silane (CAS 1067-25-0)
3. ANALOGUE APPROACH JUSTIFICATION
To reduce animal testing REACH recommends to make use of a read-across approach where appropriate based on the high accordance in properties relevant for the specific endpoint. In the case of skin sensitisation relevant properties are structural similarity as well as physical-chemical and basic toxicological parameters in the same range. In the following paragraphs the read-across approach for triethoxy(propyl)silane is evaluated point by point.
No skin sensitisation study is available for triethoxy(propyl)silane. A Buehler test is available for the analogous substance trimethoxy(propyl)silane. Trimethoxy(propyl)silane was not sensitising in guinea pigs. Both substances, triethoxy(propyl)silane (2550-02-9) and trimethoxy(propyl)silane (CAS 1067-25-0), have a medium dermal absorption potential (50%), corresponding to a dermal absorption of 0.01965 and 0.02810 mg/cm²/h, respectively. This prediction was calculated with Dermwin (2012) on the basis of molecular weight (206.35 and 164.27 g/mol), water solubility (280 and 9200 mg/L), and log Kow(3.2 and 1.7). Both substances could undergo hydrolysis, resulting in the common hydrolysis product, propylsilanetriol. The hydrolysis product is supposed to have a dermal absorption that is comparable to that of the parent substances. None of the parent substances and hydrolysis products showed a chemical structural feature indicative of sensitising potential (OECD Toolbox 2.3.0.1132). Since skin penetration is one essential step during skin sensitisation, and in the absence of any chemical structural features indicative of sensitising potential, it is considered appropriate to read-across this result to the other members of the alkoxysilane analogue group. This is supported by a larger data set of skin sensitisation studies for alkyl alkoxysilanes (PFA, 2013t). In addition the hydrolysis products methanol and ethanol are not sensitising to skin.
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% at induction, 25% at challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% at induction, 25% at challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% at induction, 25% at challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% at induction, 25% at challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- In a guinea pig skin sensitisation study (Buehler test), conducted according to OECD 406 and in compliance with GLP (reliability score 1) the structural analogue substance trimethoxypropylsilane (CAS: 1067-25-0) was not a skin sensitiser. As explained in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in acute inhalation toxicity potential.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Studies were chosen as key when the available study was of relevance and of sufficient quality for classification and labelling and for risk assessment.
There are no measured data available to assess the skin sensitisation potential of triethoxypropylsilane, therefore the structural analogue substance trimethoxypropylsilane (CAS: 1067-25-0) has been used to assess its skin sensitisation potential.
In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and following the Read across assessment framework (RAAF, ECHA 2017) read across from an analogue substance has been applied to support the human health hazard assessment of tritethoxypropylsilane. Details on read across justifications can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.
In a key reliable Buehler test conducted according to OECD TG 406 and in compliance with GLP the structural analogue substance trimethoxypropylsilane (CAS: 1067-25-0) was found to be a non-sensitiser. The sensitisation index was calculated to be 0% for the test group following challenge. Appropriate positive and solvent controls were included and gave expected results (Hüls AG, 1997). The same result is also considered for triethoxypropylsilane.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No data available.
Justification for classification or non-classification
The available data on skin sensitisation of the structural analogue substance, trimethoxypropylsilane, do not meet the criteria for classification according to Regulation (EU) 1272/2008 and are therefore conclusive but not sufficient for classification of the registered substance.
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.
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