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EC number: 643-078-7 | CAS number: 87855-59-2
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 May - 15 July, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
Test material
- Reference substance name:
- N-[ethenyl(N-ethylacetamido)methylsilyl]-N-ethylacetamide
- EC Number:
- 643-078-7
- Cas Number:
- 87855-59-2
- Molecular formula:
- C11 H22 N2 O2 Si Si(CH3)(CH=CH2)[N(CH2CH3)(C(=O)CH3)]2
- IUPAC Name:
- N-[ethenyl(N-ethylacetamido)methylsilyl]-N-ethylacetamide
- Test material form:
- solid: compact
- Details on test material:
- Identification: ZMATNo.4094103, supplied as Dow Coming® 1-6008
Source: Korea Biogen Co" Ltd" 690 Sinduk-Ri, SungnamMyuan, Chunan-City, Chungnam, 330-893, Korea
Description: Amber liquid
Lot Number: 091217
Purity: 77.9% ± 0,3 area %
Stability of Test Item: Stable under storage conditions.
Expiry Date: December 26, 20 I 0
Stability of Test Item dilution: The test item formulated in acetone-d6 appeared to be stable at concentrations of 50% and unstable at
I % within 30 minutes of preparation. Degradation at 10% and 5% was also noticeable.
Storage Conditions: At room temperature (range of 20 ± 5 QC), light protected.
Kept away from sources water or humid air.
Safety Precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Acetone-d6
- Concentration / amount:
- Concentrations at initial irritation screen (I): 100% (undiluted), 75%, 50%, 25% and acetone d-6 alone.
At induction, the test group was treated with the test item at 50% in acetone d-6 and the control group with acetone d-6 only.
At challenge, both test and conlrol group animals were treated with the test item at 1 % and 5% in acetone d-6 as well as with acetone d-6 alone.
Concentrations at initial irritation screen (2): 15%, 10%, 5% and 1 % in acetone d-6.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Acetone-d6
- Concentration / amount:
- Concentrations at initial irritation screen (I): 100% (undiluted), 75%, 50%, 25% and acetone d-6 alone.
At induction, the test group was treated with the test item at 50% in acetone d-6 and the control group with acetone d-6 only.
At challenge, both test and conlrol group animals were treated with the test item at 1 % and 5% in acetone d-6 as well as with acetone d-6 alone.
Concentrations at initial irritation screen (2): 15%, 10%, 5% and 1 % in acetone d-6.
- No. of animals per dose:
- 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% in acetone d-6
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% in acetone d-6. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% in acetone d-6
- 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: 1% in acetone d-6 . No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% in acetone d-6
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% in acetone d-6. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% in acetone d-6
- 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: 5% in acetone d-6. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% acetone d-6
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100% acetone d-6. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% acetone d-6
- 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: 100% acetone d-6. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- no visible change
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: no visible change.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- discrete or patchy erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- no visible change
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: no visible change.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- discrete or patchy erythrema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythrema.
Any other information on results incl. tables
Viability / Mortality / Macroscopic Findings
There were no deaths during the course of the study, hence no necropsies were performed.
Skin Reactions in the Induction
No skin effect was observed in the control group after treatment with acetone d-6 during the
three weeks of induction.
Discrete/patchy erythema was observed in 85% of the test animals after treatment with the test
item at 50% in acetone d-6 during the first week: of induction. Discrete/patchy erythema was
observed in all test animals during the second and third weeks of induction.
Skin Reactions in the Challenge
No skin reactions were observed in neither the control nor test animals after treatment with the
test item at 1 % and 5% in acetone d.6, or with acetone d-6 alone.
The control and test animals were depilated three hours prior to the 24-hour reading to facilitate
the reading of the skin reactions.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test substance did not exhibit the ability to induce dermal sensitization in guinea pigs when used as such,
- Executive summary:
The purpose of this skin sensitizing study was to assess the .ability of test item, ZMA T No.
4094103, to induce delayed contact hypersensitivity when administered topically to albino
guinea pigs.
For this purpose the "Buehler Test" modified by Ritz, H.L. and Buehler, E.V. (1980) was used.
Twenty male animals of the test group were treated topically with ZMATNo. 4094103 at 50% in
acetone d·6 once a week for a 3·week induction phase. The ten animals of the control group
were treated in the same way as the test animals with the vehicle (acetone d-6) only. Two weeks
aller the final induction application the control and test animals were challenged with the test
item at I % and 5% in acetone d-6 as well as with acetone d-6 alone.
No skin reactions were recorded in neither the control nor test groups after topical challenge with
ZMA T No, 4094103 at 1 % and 5% in acetone d·6 or with acetone d·6 alone.
Under the conditions of this study, ZMAT No, 4094103 did not exhibit the ability to induce
dermal sensitization in guinea pigs when used as such,
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