Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 216-467-0 | CAS number: 1591-02-2
- 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:
- January 2015 - February 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to current OECD guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Dibutoxy(dimethyl)silane
- EC Number:
- 216-467-0
- EC Name:
- Dibutoxy(dimethyl)silane
- Cas Number:
- 1591-02-2
- Molecular formula:
- C10H24O2Si
- IUPAC Name:
- dibutoxydimethylsilane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: CrI: HA
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 4 weeks old
- Weight at study initiation: 330 - 403 g
- Housing: The animals were kept in groups in Terluran - cages on Altromin saw fibre bedding (lot no. 02102141114)
- Diet: Free access to autoclaved hay and to Altromin 3122 maintenance diet for guinea pigs (lot no. 0830), rich in crude fibre
- Water: Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 10%
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- Induction - 100%
Challenge - 25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- Induction - 100%
Challenge - 25%
- No. of animals per dose:
- preliminary test: 4
the test group: 20
negative-control group: 10 - Details on study design:
- RANGE FINDING TESTS:
Based on the results of this preliminary test the following concentrations were chosen for the main test:
100% for the dermal inductions (highest possible concentration that produced mild irritation)
25% for the challenge application (maximum non-irritant concentration)
MAIN STUDY
A. INDUCTION EXPOSURE
The left flank was cleared of hair (close-clipped) prior to the first application and again prior to further applications. A gauze patch was loaded with 0.5 mL of the test substance. The patch was applied to the test area of approximately 2.5 x 2.5 cm and was held in contact with the help of an occlusive dressing for 6 hours. This procedure was repeated once a week at the same test area at weekly intervals for 3 weeks. Control group received a similar treatment with no test item.
B. CHALLENGE EXPOSURE
Both flanks were cleared of hair (close-clipped) prior to the challenge application. 14 days after the last induction application the prepared test substance was applied to an area of approximately 2.5 x 2.5 cm on the right flank and was held in contact with the help of an occlusive dressing for 6 hours. A patch loaded with the vehicle was applied to an area of approximately 2.5 x 2.5 cm on the left flank (intraspecific control) and was held in contact with the help of an occlusive dressing for 6 hours. - Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Induction 1
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Erythema Grade 1
- Remarks on result:
- other: Reading: other: Induction 1. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: Erythema Grade 1 .
- Reading:
- other: Induction 2
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Clinical observations:
- Erythema Grade 1
- Remarks on result:
- other: Reading: other: Induction 2. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 15.0. Total no. in groups: 20.0. Clinical observations: Erythema Grade 1 .
- Reading:
- other: Induction 3
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- Erythema Grade 1
- Remarks on result:
- other: Reading: other: Induction 3. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: Erythema Grade 1 .
- Reading:
- other: Challenge
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No evidence of sensitisation in any animals at any time point.
- Remarks on result:
- other: Reading: other: Challenge. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No evidence of sensitisation in any animals at any time point..
- Reading:
- other: induction and challenge
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No reactions were recorded at any time point in any animals.
- Remarks on result:
- other: Reading: other: induction and challenge. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No reactions were recorded at any time point in any animals..
- Reading:
- other: challenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 15%
- Clinical observations:
- 60% of the animals were sensitised at 24 hours
- Remarks on result:
- other: Reading: other: challenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 15%. Clinical observations: 60% of the animals were sensitised at 24 hours.
- Reading:
- other: challenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 15%
- Clinical observations:
- 40% of the animals were sensitised at 48 hours
- Remarks on result:
- other: Reading: other: challenge. . Hours after challenge: 48.0. Group: positive control. Dose level: 15%. Clinical observations: 40% of the animals were sensitised at 48 hours.
Any other information on results incl. tables
The body weight development of all animals was within the range of variation for the strain of animals used.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was found not sensitising in a Buehler test, in a study conducted according to guideline and in compliance with GLP.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.