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EC number: 253-634-7 | CAS number: 37697-65-7
- 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:
- 1988-08-05 to 1990-04-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Information regarding positive control group not included in the report.
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
Test material
- Reference substance name:
- 1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine
- EC Number:
- 253-634-7
- EC Name:
- 1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine
- Cas Number:
- 37697-65-7
- Molecular formula:
- C13H33N3Si
- IUPAC Name:
- {bis[(butan-2-yl)amino](methyl)silyl}(butan-2-yl)amine
- Test material form:
- other: viscous liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elevage Lebeau, France
- Age at study initiation: young adults
- Weight at study initiation: 341 - 500 g
- Housing: housed by sex in groups of 5 or 6 in polystyrene cages
- Diet: complete pelleted guinea-pig maintenance diet, ad libitum
- Water: filtered and softened drinking water, ad libitum
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 27.5
- Humidity (%): 23 - 83
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sterile Codex liquid paraffine
- Concentration / amount:
- Range finder: Undiluted, 25%, 10%, 5% and 1%
Test group:
Induction - 1 %
Challenge - 1 %
0.5 ml of the test article in 1 % (W/W) solution in sterile Codex liquid paraffin.
Negative control group: 0.5 ml per animal of sterile Codex liquid paraffin.
Positive control group: not included in the study
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sterile Codex liquid paraffin
- Concentration / amount:
- Range finder: Undiluted, 25%, 10%, 5% and 1%
Test group:
Induction - 1 %
Challenge - 1 %
0.5 ml of the test article in 1 % (W/W) solution in sterile Codex liquid paraffin.
Negative control group: 0.5 ml per animal of sterile Codex liquid paraffin.
Positive control group: not included in the study
- No. of animals per dose:
- Test group: 10 (+1) males, 10 (+1) females
Control group: 10 males, 10 females - Details on study design:
- RANGE FINDING TESTS:
PRELIMINARY STUDY:
The test material was applied undiluted, then in 25 %, 10 %, 5 % and 1 % (w/w) solution in sterile Codex liquid paraffin to guinea-pig skin. When undiluted, total necrosis of the application site was observed in the 4 treated animals. When 25 % solution of the test material was applied to the skin, moderate irritation and less than a quarter burnt aspect of the application site was observed in 3 out of 4 animals. Following 10 % solution application, erythema was noted in 3 out of 4 guinea-pigs. When 5 % solution was applied to the skin, less than a quarter of the area was burnt in 1 out 4 animals with no evidence of erythema or oedema. Following 1 % solution of the test material in sterile Codex liquid paraffin, no cutaneous abnormality was observed.
MAIN STUDY
A. INDUCTION EXPOSURE
The left lateral abdominal region was clipped and shaved. The test material and the vehicle (sterile Codex liquid paraffin) were applied at days 1, 8 and 15. 0.5 ml of sterile Codex liquid paraffin was applied to the control group and 0.5 ml in 1 % (W/W) sterile Codex liquid paraffin was applied to the treated group. An occlusive dressing kept the test material/vehicle in contact with the skin. The exposure period was 6 hours. The animals were not subject to treatment from day 15 until day 29 from the study period.
B. CHALLENGE EXPOSURE
The application area was clipped and then shaved. 0.5 ml of the test material in 1 % (W/W) sterile Codex liquid paraffin was applied to the posterior flank of the abdominal region and 0.5 ml of sterile Codex paraffin was applied to the anterior flank of the abdominal region. The test material was applied at day 29 from the study period. The test material and the vehicle were both kept with an occlusive patch for 6 hours onto the skin. - Challenge controls:
- 0.5 ml per animal of sterile Codex liquid paraffin.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No positive control data.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 ml of sterile Codex liquid paraffin
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 ml of sterile Codex liquid paraffin
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 ml sterile Codex liquid paraffin
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 ml sterile Codex liquid paraffin
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Two females were found dead at 1 day and 1 month after the 'challenge' application. No clinical sings were observed after necropsy. Both animals were replaced by guinea-pigs from the complementary group. No other clinical changes were observed.
Slight increase in the body weight was observed during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 1-Methyl-N,N',N''-tris(1-methylpropyl)silanetriamine is reported to be not sensitising to guinea pig skin in the study, conducted according to OECD TG 406 and in compliance with GLP.
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