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EC number: 274-936-5 | CAS number: 70851-50-2
- 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
Buehler test (OECD 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Aug 2014 – 29 Sep 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- (2003)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Buehler type of sensitization test was selected since the test substance is a functional silane and the Local Lymph Node Assay as the preferred alternative has shown to provide false positive results for silicone substances.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L’Arbresle Cedex, France
- Age at study initiation: approximately 4 weeks old
- Housing: in groups of maximum 5 animals per labelled Noryl cage (Tecniplast; 74 cm x 54 cm x 25 cm height) containing sterilised sawdust as bedding material (Lignocel S 8-15, JRS – J. Rettenmaier & Söhne GmbH + CO. KG, Roshenberg, Germany) and shelters (CS3B02A Play tunnels (90 mm x 5 mm x 125 mm), Datesand, Manchester, UK) as cage enrichment.
- Diet: complete maintenance diet for guinea pigs (MS-H, SSNIFF® Spezialdiäten GmbH, Soest, Germany). Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least twice a week.
- Water: tap water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- - Range finding study: 10, 20, 50 and 100% (v/v)
- Main study: 100% (neat test material) - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- - Range finding study: 10, 20, 50 and 100% (v/v)
- Main study: 100% (neat test material) - No. of animals per dose:
- 4 in the preliminary irritation test
20 in the test group of main study
10 in the negative control goup of the main study - Details on study design:
- RANGE FINDING TESTS:
4 animals were used in total in the range finding test. Two different concentrations (2 animals at 10% and 20%; 2 animals at 50% and 100%) were applied (0.5 ml) per animal to the clipped flank using Metalline patches (2x3) mounted on Medical tape, then held in place with Micropore tape and subsequently Coban elastic bandage. After 6 hours, the dressing was removed and the skin cleaned of residual test substance with water. The resulting dermal reactions were assessed for irritation 24 and 48 hours after removal of the last dressing. Based on the results of this preliminary test the following concentrations were chosen for the main test:
- 100% for the dermal inductions
- 100% for the challenge application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 0.5 ml of the neat test substance
- Control group: 0.5 ml of corn oil
- Site: left flank
- Frequency of applications: every 7 days (days 8 and 15 of the study)
- Duration: days 1-15
- Concentrations: 100% (undiluted)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 h
- Test groups: 0.1 ml of the neat test substance and 0.1 ml of the vehicle
- Control group: 0.1 ml of the neat test substance and 0.1 ml of the vehicle
- Site: posterior right flank (test substance) and anterior right flank (corn oil)
- Concentrations: 100% (undiluted)
- Evaluation (hr after challenge): 24 and 48 h
Animals used in the main sensitisation assessment were weighed on Day 1 of the study and again on termination of the study following completion of the challenge procedures.
All animals were killed following the end of the experimental procedure. No necropsy examination was performed in these animals. - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- The recent reliability check was performed in September 2014: Alpha-hexylcinnamicaldehyde undiluted (induction) and 50% in water (challenge)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 100%; challenge: 100%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- A grade 1 skin reaction was observed in one experimental animal on day 29 in response to the test substance
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Induction: 100%; challenge: 100%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: A grade 1 skin reaction was observed in one experimental animal on day 29 in response to the test substance.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 100%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- A grade 1 skin reaction was observed in one control animal on day 29 in response to the test item
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Induction: 0%; challenge: 100%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: A grade 1 skin reaction was observed in one control animal on day 29 in response to the test item.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Induction: 0%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 100%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Induction: 100%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- The test item was investigated for skin sensitising potential in a Buehler Test conducted in accordance with OECD TG 406 and in compliance with GLP. The skin reaction observed in response to the undiluted test substance in one (of the twenty) experimental animals in the challenge phase was considered not indicative of sensitisation, based on the presence of a similar response in one of the control animal. Therefore, the test item is concluded to be not sensitising under the conditions of this test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitising potential of dimethoxymethyloctadecylsilane was investigated in a guinea pig skin sensitisation study (Buehler test) according to OECD 406 and in compliance with GLP (WIL, 2004). The animals were induced thrice (every 7 days) with 0.5 ml of the undiluted test substance (20 animals of the test group) or with vehicle (10 animals of the control group) for 6 hours, each, under occlusive conditions. The challenge was performed in the same way as the induction. The skin reactions were scored 24 and 48 h after application. A grade 1 skin reaction was observed in one experimental and one control animal on day 29 in response to the test substance. The skin reaction observed in response to the undiluted test substance in one (of the twenty) experimental animal in the challenge phase was not indicative of sensitisation, based on the presence of a similar response in one of the control animals. In conclusion, dimethoxymethyloctadecylsilane is not sensitising to the skin under the conditions applied.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation of the registered substance do not meet the criteria for classification according to Regulation 1272/2008 or EU Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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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