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Diss Factsheets
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EC number: 700-805-3 | CAS number: -
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- reaction mass of 1-vinylcyclohex-3-enecarbaldehyde and 4-vinylcyclohex-1-enecarbaldehyde
- EC Number:
- 700-805-3
- Molecular formula:
- C9H12O
- IUPAC Name:
- reaction mass of 1-vinylcyclohex-3-enecarbaldehyde and 4-vinylcyclohex-1-enecarbaldehyde
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 1, 10 and 50% (w/v)
- No. of animals per dose:
- 5
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Test item concentration S.I. Vehicle Control Group (acetone:olive oil (4+1 v/v)) 1.00 1% GR-50-0091 1.42 10% GR-50-0091 1.68 50% GR-50-0091 6.59
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Test item concentration Mean DPM per animal (2 lymph nodes) Vehicle Control Group (acetone:olive oil (4+1 v/v)) 661.8 1% GR-50-0091 938.6 10% GR-50-0091 1109.8 50% GR-50-0091 4363.0
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In order to study a possible contact allergenic potential of GR-50-0091, three groups each
of five female mice were treated once daily with the test item at a concentrations of 1, 10,
and 50% (w/v) in acetone:olive oil (4+1 v/v) by topical application to the dorsum of each
ear for three consecutive days. The highest concentration tested was the highest
concentration that could be achieved whilst avoiding systemic toxicity and excessive local
skin irritation as confirmed by two pre-experiments. Two further groups each of five mice
were treated with the vehicle only (acetone:olive oil (4+1 v/v)) or with the positive control
item at 25% (w/v). Five days after the first topical application the mice were injected
intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine).
Approximately five hours after intravenous injection, the mice were sacrificed, the draining
auricular lymph nodes excised and pooled per animal. Single cell suspensions of lymph
node cells were prepared from pooled lymph nodes, which were subsequently washed and
incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph
node cells was determined by the incorporation of 3H-methyl thymidine measured in a -
scintillation counter.
Cases of mortality were not observed during the course of the study. Animals treated with
the highest test item concentration showed an erythema of the ear skin (Score 1) on
application day 4 and 5. A statistically significant increase in ear weight was seen in the
groups treated with 50 and 10% test item concentration; however, as the observed
increase (18.7% in the mid dose and 17.3% in the high dose group, respectively) was well
below the threshold of 25% for excessive skin irritation, this was not considered as
biologically relevant. Furthermore, the measured ear thickness did not show a relevant
increase.
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test
concentration resulted in a 3-fold or greater increase in incorporation of 3HTdR compared
with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated
concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value.
In this study Stimulation Indices of 1.42, 1.68, and 6.59 were determined with the test item
at concentrations of 1, 10, and 50% (w/v) in acetone:olive oil (4+1 v/v). A clear dose
response was observed. A statistically significant increase in the mean DPM value was
observed in the group treated with 50% test item concentration in comparison to the value
of the vehicle control group. The EC3 value calculated was 20.8 %. The S.I. determined
for the positive control was 9.56, demonstrating the validity of the study.
The test item GR-50-0091 was found to be a skin sensitiser under the test conditions of
this study.
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