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EC number: 217-126-9 | CAS number: 1746-23-2
- 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:
- July, 2016 to October, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A guinea pig maximisation study was conducted as the most approriate test method for the test substance.
Test material
- Reference substance name:
- Vinyltoluene
- EC Number:
- 246-562-2
- EC Name:
- Vinyltoluene
- Cas Number:
- 25013-15-4
- Molecular formula:
- C9H10
- IUPAC Name:
- Ethenylmethylbenzene
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: BFA (Albino)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lubos Sobota, Czech Republic
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Adults
- Housing: in cages on soft wood shavings
- Diet (e.g. ad libitum): Altromin Spezialfutter GmbH
- Water (e.g. ad libitum): Yes
- Acclimation period: min 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 / 12
- IN-LIFE DATES: From: To:25.7 - 26.8.2016
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Freund's Complete Adjuvant:Saline (1:1; v/v)
- Concentration / amount:
- 0.1 ml
- Day(s)/duration:
- Single injection on Day 0
- Adequacy of induction:
- other: Treated group
- Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- 0.1 ml, 20% test substance in olive oil
- Day(s)/duration:
- Single injection on Day 0
- Adequacy of induction:
- other: Treated group
- Route:
- intradermal
- Vehicle:
- other: Freund's Complete Adjuvant: Saline (1:1, v/v)
- Concentration / amount:
- 0.1 ml, 20% test substance in FCA:Saline (1:1)
- Day(s)/duration:
- Single injection on Day 0
- Adequacy of induction:
- other: Treated group
- Route:
- intradermal
- Vehicle:
- other: Freund's Complete Adjuvant: Saline (1:1, v/v)
- Concentration / amount:
- 0.1 ml
- Day(s)/duration:
- Single injection on Day 0
- Adequacy of induction:
- other: Control group
- Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- 0.1 ml
- Day(s)/duration:
- Single injection on Day 0
- Adequacy of induction:
- other: Control group
- Route:
- intradermal
- Vehicle:
- other: 50% formulation of Freund's Complete Adjuvant:saline (1:1, v/v)
- Concentration / amount:
- 0.1 ml
- Day(s)/duration:
- Sngle injection on Day 0
- Adequacy of induction:
- other: Control group
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% test substance
- Day(s)/duration:
- 48 h application on shaved skin on Day 6
- Adequacy of induction:
- other: Treated Group
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 100%
- Day(s)/duration:
- 48 h application on shaved skin on Day 6
- Adequacy of induction:
- other: Control group
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 70% test substance in olive oil
- Day(s)/duration:
- 24 h application on shaved skin on Day 20, right flank of all animals
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 100% olive oil
- Day(s)/duration:
- 24 h application on shaved skin on Day 20, left flank of all animals
- No. of animals per dose:
- Treated group: 20 animals (11 males and 9 females)
Control group; 10 animals (6 males and 4 females) - Details on study design:
- Obervation of skin reactions on Days 22-23 at 48 h from the challenge application, then again 24 h later (72 h from challenge application)
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20% test substance in olive oil (induction), 70% test substance in olive oil (challenge)
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- One animal with discrete or patchy erythema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 20% test substance in olive oil (induction), 70% test substance in olive oil (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- None
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- Not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- None
Any other information on results incl. tables
The bodyweights of the animals in the treated groups did not differ significantly from those of the control group throughout the study.
Treated animals did not show any clinical symptoms of intoxication.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the Magnusson and Kligman Guinea pig maximisation study, the test substance was not considered to be sensitising.
- Executive summary:
A study was conducted to determine the skin sensitisation potential of the test substance according to EU Method B6 (Magnusson and Kligman maximisation test), in compliance with GLP. A pilot experiment was implemented on 3 animals. The main study was performed on 20 treated and 10 control animals (males and females). The experiment proceeded in 3 phases: two induction phases (intradermal injections and topical occlusive application) and the challenge phase. Potential skin reactions were evaluated at the end of the experiment. The evaluation of skin reactions in the treated group carried out 48 h after the start of the challenge phase showed discrete erythema in 1 of 20 animals (5%) in the left flank exposed to the test substance. No other negative clinical symptoms were recorded throughout the experiment. Under the conditions of the Magnusson and Kligman Guinea pig maximisation study, the test substance was not considered to be sensitising (Chudobová, 2016).
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