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EC number: 230-636-6 | CAS number: 7235-40-7
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2010-01-26 to 2010-02-16
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study, according to OECD guideline. The study was performed with a formulation containing 13.1% beta-Carotene.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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:
- β,β-carotene
- EC Number:
- 230-636-6
- EC Name:
- β,β-carotene
- Cas Number:
- 7235-40-7
- Molecular formula:
- C40H56
- IUPAC Name:
- β,β-carotene
- Details on test material:
- - Name of test material (as cited in study report): beta-carotene 10% CWS Star
- Analytical purity: 13.1% beta-Carotene content, dose calculation not adjusted to purity
- Lot/batch No.: UT08070004
- Expiration date of the lot/batch: July 2011
- Storage condition of test material: at +2 - +8 °C, light and moisture protected
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories BV, Postbus 6174, 5960 AD Horst / The Netherlands
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 18-22 g
- Housing: single
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 20-65
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol:deionised water (3+7)
- Concentration:
- 5, 10, 25%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 25% (w/w) suspension in ethanol:deionised water (3+7)
- Irritation: the top dose (25%) is the highest technically achievable concentration whilst avoiding systemic toxicity and excessive local irritation
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response:
-exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index.
-the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
Topical Application
Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear (left and right) with different test item concentrations of 5, 10 and 25% (w/w) in ethanol:deionised water (3+7). The application volume, 25 µL, was spread over the entire dorsal surface (Ø ~ 8 mm) of each ear once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals)
Administration of 3H-Methyl Thymidine (3HTdR)
Five days after the first topical application, all mice received a single dose of 250 µL of 80.9 µCi/mL 3HTdR (corresponds to 20.2 µCi 3HTdR per mouse) by intravenous injection via a tail vein. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations of the body weight were calculated.
Results and discussion
- Positive control results:
- A GLP-conform study with the positive reference substance revealed the sensitivity and suitability of the test system.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.52
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 1.37
- Test group / Remarks:
- 10 %
- Parameter:
- SI
- Value:
- 1.5
- Test group / Remarks:
- 25 %
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 5 %: 359.8 10 %: 324.2 25 %: 355.4
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- The test item beta-Carotene 10 % CWS Star was not a skin sensitiser under the described conditions.
- Executive summary:
In a GLP and the OECD guideline 429 conform study, the test item beta-Carotene 10 % CWS Star suspended in ethanol:deionised water (3:7) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed using test item concentrations of 5, 10 and 25 % (w/w). The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study, Stimulation Indices (SI) of 1.52, 1.37 and 1.50 were calculated for the groups treated with the test item at concentrations of 5, 10 and 25 % in ethanol:deionised water (3:7), respectively. The test item beta-carotene 10 % CWS Star was not a skin sensitiser in this assay.
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