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Registration Dossier
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EC number: 213-668-5 | CAS number: 999-97-3
- 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:
- OECD 406 (Buehler test) commissioned
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- 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:
- N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine
- EC Number:
- 231-701-1
- EC Name:
- N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine
- Cas Number:
- 7691-02-3
- Molecular formula:
- C8H19NSi2
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan laboratories, The Netherlands
- Age at study initiation: 4-6 weeks
- Weight at study initiation: test group: 373.1-408 g
- Housing: in groups of up to ten in stainless steel cages with standard softwood bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: diglyme, 75% w/w mixture
- Concentration / amount:
- INDUCTION: 25% w/w
CHALLENGE: 0.1% w/w and 0.5% w/w
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: diglyme, 75% w/w mixture
- Concentration / amount:
- INDUCTION: 25% w/w
CHALLENGE: 0.1% w/w and 0.5% w/w
- No. of animals per dose:
- Pretests: 3
Controls: 10
Test group: 20 - Details on study design:
- RANGE FINDING TESTS: Pretest 1 was performed during the acclimatization of the main study animals. The test item concentrations were selected during the preliminary solubility testing. The test item was formulated in the vehicle. Pretests 2 and 3 were performed during the induction period in order to find the highest non-irritant test item concentration for the challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
The induction of the main test was performed within three weeks. A total of three inductions (one per week) was performed. The test item concentration used for the induction was determined based on the results of pretest 1. A test item concentration of 25% (w/w) in diglyme was well tolerated systemically and caused mild-to-moderate skin irritation.
The application was performed at the same shoulder of the animals in the first and in the second week of the induction period. As crusts were observed after the second induction in the test group, a naive application site on the right shoulder was used for the third induction for both test and control group. After the last induction exposure, the animals were left untreated for approximately 2 weeks before the challenge.
B. CHALLENGE EXPOSURE
The challenge was performed ca. 2 weeks after the last induction. The test item concentration used for the challenge was determined based on the results of the pretests. All concentrations higher than 0.5% (w/w) tested in the pretests produced in signs of skin irritation. Test item concentrations of 0.5% (w/w) and 0.1% (w/w) in diglyme were well tolerated systemically and 0.5% (w/w) in diglyme was the highest non-irritant concentration. - Challenge controls:
- No skin reactions were observed.
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Vehicle (diglyme, 75% w/w mixture)
- No. with + reactions:
- 0
- 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:
- Vehicle (diglyme, 75% w/w mixture)
- 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:
- negative control
- Dose level:
- Vehicle (diglyme, 75% w/w mixture)
- 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:
- Vehicle (diglyme, 75% w/w mixture)
- 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:
- 0.5% test item in diglyme
- No. with + reactions:
- 0
- 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:
- 0.5% test item in diglyme
- 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:
- negative control
- Dose level:
- 0.5% test item in diglyme
- 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:
- 0.5% test item in diglyme
- 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:
- 0.1% test item in diglyme
- No. with + reactions:
- 0
- 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:
- 0.1% test item in diglyme
- 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:
- negative control
- Dose level:
- 0.1% test item in diglyme
- 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:
- 0.1% test item in diglyme
- 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:
- positive control
- Dose level:
- alpha-hexylcinnamaldehyde
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- >15 % of the animals got dermatitis
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- alpha-hexylcinnamaldehyde
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- >15 % of the animals got dermatitis
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on a non-adjuvant sensitisation test in guinea pigs conducted according to OECD Test Guideline 406 and in compliance with GLP, the test item N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylaminen (CAS 7691 -02 -3) was found not sensitising to guinea-pig skin.
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