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EC number: 250-437-8 | CAS number: 31024-56-3
- 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:
- 04 Dec 2012 - 13 Feb 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- 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 (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Erlangen, Germany
- 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.
Test material
- Reference substance name:
- N-[3-(trimethoxysilyl)propyl]butylamine
- EC Number:
- 250-437-8
- EC Name:
- N-[3-(trimethoxysilyl)propyl]butylamine
- Cas Number:
- 31024-56-3
- Molecular formula:
- C10H25NO3Si
- IUPAC Name:
- butyl[3-(trimethoxysilyl)propyl]amine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hartley (Crl:HA-Guinea Pigs (full barrier))
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: approximately 4 weeks old
- Weight at study initiation: 301-377 g
- Housing: in groups in Terluran-cages on Altromin saw fibre bedding (lot no. 011012)
- Diet: autoclaved hay and Altromin 3122 maintenance diet for guinea pigs (lot no. 1311/0807), rich in crude fibre, ad libitum
- Water: tap water (drinking water, municipal residue control, microbiological controls at regular intervals), ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% (neat test material)
- Day(s)/duration:
- Days 1, 8 and 15
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- Day 28
- No. of animals per dose:
- - 2 for the preliminary 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:
2 animals were treated topically with concentrations of 50% and 100% of the test item (suspended with vaseline) for 6 hours. Vaseline was chosen as vehicle due to its non-irritating characteristics. 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: a gauze patch loaded with 0.5 ml of the neat test substance
- Control group: a dry gauze patch, as no vehicle was used in the main study
- Site: left flank
- Frequency of applications: once a week
- 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: a gauze patch loaded with 0.5 ml of the neat test substance (right flank) and a dry gauze patch, as no vehicle was used in the main study (left flank)
- Control group: a gauze patch loaded with 0.5 ml of the neat test substance (right flank) and a dry gauze patch, as no vehicle was used in the main study (left flank)
- Site: right and left flanks
- Concentrations: 100% (undiluted)
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- The recent reliability check was performed in October/November 2012: mercaptobenzothiazole (purity 98%), 50% in vaseline (induction) and 25% in vaseline (challenge)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- positive control is checked in laboratory on regular basis
Any other information on results incl. tables
Preliminary Test
2 animals were treated topically with concentrations of 50% and 100% of the test item (suspended with vaseline) for 6 hours. Based on the results of this preliminary test, a concentration of 100% was selected for the inductions as well as for the challenge. This concentration did not cause any signs of irritation after a topical treatment over a period of 6 hours.
Main Test
Dermal Induction I, II and III (6-hour exposure, occlusive):
- Immediately after removing the patch: no signs of irritation were observed in any of the animals
- 24 hours after removing the patch: no signs of irritation were observed in any of the animals
Challenge Exposure (6-hour exposure, occlusive):
- The results of the test animals at the challenge phase were compared to the results of the control animals. Neither erythema nor oedema was observed in any animal at any time of observation. There was no evidence of sensitisation and the percentage of sensitised animals was 0%.
- All animals of both groups survived throughout the test period. No signs of toxicity were recorded. The body weight development was within the biological range for all animals compared to historical data.
Applicant's summary and conclusion
- 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. There were no signs of skin reactions after induction and challenge with the neat test material in any of the animals. Therefore, the test item is concluded to be not sensitising under the conditions of this test.
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