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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 249-385-9 | CAS number: 29043-70-7
- 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:
- 1995-08-02 to 1996-07-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation 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:
- Dimethylbis(octadecyloxy)silane
- EC Number:
- 249-385-9
- EC Name:
- Dimethylbis(octadecyloxy)silane
- Cas Number:
- 29043-70-7
- Molecular formula:
- C38H80O2Si
- IUPAC Name:
- dimethylbis(octadecyloxy)silane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A., Calco (Como), Italy.
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 300-350 g
- Housing: groups of up to 5 animals in stainless steel cages (63x48x41 cm), with a grid floor. Cages were suspended over metal trays which held an absorbent material.
- Diet: ad libitum - commercially available laboratory diet (Altromin MSK, A. Rieper S.p.A., Bolzani, Italy)
- Water: ad libitum
- Acclimation period: at least 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 45-65%
- Air changes (per hr): no information given in study report
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1995-10-26 To: 1995-12-07
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 10%
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 75%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 50%
- No. of animals per dose:
- test group: 20; control group: 10
- Details on study design:
- RANGE FINDING TESTS:
Intradermal injection tolerance test: The hair over the scapulae was clipped and 0.1 ml of 50, 20, 10, 5, 1 and 0.1% of test substance in coconut oil were administered to 2 guinea pigs by intradermal injection. Erythema and eschar formation was scored using the Draize scoring scale seven days after injection. The highest concentration which was reasonably tolerated by the test system was selected for the intradermal induction stage of the main study.
Topical application tolerance test: The hair over the scapulae was clipped from 5 guinea pigs. Each animal was injected intradermally with 2 injections, each of 1 ml of emulsified Freund's adjuvant. 7 days later, the flanks were clipped and each animal was dosed with 2 concentrations of the test substance, one on each flank. A gauze patch was soaked with 0.2 ml of the selected concentration of the test substance and placed onto the selected treatment site. The sites were covered with a strip of aluminium foil to act as an occlusive barrier and the trunk of the animal was wrapped with an elastic adhesive bandage. Concentrations of 75, 50, 20, 10 and 5% of test substance in coconut oil were applied in duplicate. The dressings and patches were removed after 24h contact with the skin. Each site was assessed and scored. The highest reasonably achievable concentration which was tolerated by the test system, exhibiting no irritant response, was selected for the topical induction stage of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Day 1 and 8
- Test groups: 3 pairs of 0.1 ml intradermal injections were made at the edge of the prepared site; the anterior (emulsified Freund's complete adjuvant) and median (10% test substance in coconut oil) injections were positioned close together and distant from the posterior (10% test substance in emulsified Freund's complete adjuvant) injections. Skin reaction at the injected sites was assessed approximately 24 hours after injection.
Six days after injection, animals were clipped and 0.5 ml of 10% sodium lauryl sulphate in petrolatum was spread evenly over the sites intended to enhance potential absorption of the test substance. On day 8 animals were treated with the 75% test substance. A gauze patch was covered with 0.4 ml of the substance and placed over the injection sites. This was covered with a strip of aluminium foil to serve as an occlusive barrier and the animal was wrapped with elastic adhesive bandage to maintain the patch in contact with the skin. Reaction to topical treatment was assessed approximately 24 hours after removal of dressing.
- Control group: Treated in the same manner as the test group on days 1 and 8 with the test substance being replaced by the vehicle alone. Skin reaction at the injected sites was assessed approximately 24 hours after injection. Reaction to topical treatment was assessed approximately 24 hours after dressing removal.
- Site: clipped scapular region over an area of approximately 2 0 x40 mm.
- Frequency of applications: a single induction by injection was followed on day 8 by a single topical induction.
- Duration: After a contact period of 48 hours the dressings were removed and the treated sites gently cleaned with warm water.
- Concentrations: 10% (intradermal), 75% (dermal)
B. CHALLENGE EXPOSURE
- No. of exposures: single exposure
- Day(s) of challenge: Day 22
- Exposure period: 24 hours
- Test groups: Patches of 20 x 20 mm gauze were soaked with 0.2 ml aliquots of 50% test substance and placed on the right flank of each animal in the centre of the prepared skin site. The left flank was similarly treated with patches soaked with 0.2 ml of coconut oil. The treated sites were covered with a strip of aluminium foil and wrapped with elastic adhesive bandage.
- Control group: Treated in the same manner as the test groups.
- Site: 50 x 50 mm clipped areas on flank
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 hours
OTHER: Freund's complete adjuvant (FCA), a mixture or paraffin oil, an emulsifier and killed mycobacteria, was used to enhance the potential of the substance to cause a delayed contact hypersensitivity reaction - used as a 50% v/v emulsion of FCA in sterile water. The test substance was mixed with the adjuvant prior to emulsification with sterile water. - Challenge controls:
- The sensitivity of the guinea pig breed used for the sensitisation test was monitored; the last sensitivity test was carried out from 31 July to 21 August 1995.
- Positive control substance(s):
- yes
- Remarks:
- Benzocaine
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: challenge
- Hours after challenge:
- 0
- Group:
- positive control
- Dose level:
- 30% Benzocaine in petrolatum
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 70% response to 30% Benzocaine in petrolatum in rest group and 0% response in control group (number of animals not specified) in reliability check carried out July to August 1995
Any other information on results incl. tables
Some test group animals (2/20) had reactions at the vehicle application site and at the test substance (50%) application site, 24 hours after challenge exposure. There were no such observations after 48 hours. An additonal 2/20 animals in the test group had reactions at the vehicle application site only. Therefore, overall 4/20 animals in the test group had reactions to the vehicle, which were quickly reversed (by 48 hours). This was suggestive of an irritant effect of the vehicle.
Control animals did not have any reactions at 24 or 48 hours after challenge exposure.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dimethylbis(octadecyloxy)silane has been tested for in a guinea pig maximisation study using the method of Magnusson and Kligman in a study conducted according to OECD TG 406 and in compliance with GLP. Two weeks after the induction phase of a single intradermal injection of 10% test substance in Alembicol D with and without Freund's adjuvant followed one week later by occlusive application of 75% test substance in Alembicol D the animals were challenged with a 50% solution of test substance in the same vehicle. In the test group, mild reactions to test substance (50% in vehicle) were observed in 2/20 animals and to vehicle alone in a further 2/20 test animals at the 24 hour observation; these were fully resolved by the 48 hour observation. No reactions were observed in any of the 10 negative control animals. It was concluded that the observed effects indicated a mild skin irritation reaction to the vehicle and the test substance was not sensitising to skin.
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.