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EC number: 248-765-1 | CAS number: 27987-25-3
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- July 2010
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- July 2012
- Principles of method if other than guideline:
- The study procedure was extended to include additional measures of lymph node response including lymph node cell count, lymph node weight and ear weight as an indicator of skin irritation to put the data into perspective.
The basis for these additions are described in:
- Kolle et al., Performance standards and alternative assays: practical insights from skin sensitization. Regul Toxicol Pharmacol. 2013 Mar; 65(2):278-85.
- Kolle et al., Further experience with the local lymph node assay using standard radioactive and nonradioactive cell count measurements. J Appl Toxicol. 2012 Aug; 32(8):597-607.
- Basketter et al., Experience with local lymph node assay performance standards using standard radioactivity and nonradioactive cell count measurements. J Appl Toxicol. 2012 Aug;32(8):590-6. - GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Bis(methylcyclohexyl) phthalate
- EC Number:
- 248-765-1
- EC Name:
- Bis(methylcyclohexyl) phthalate
- Cas Number:
- 27987-25-3
- Molecular formula:
- C22H30O4
- IUPAC Name:
- bis(1-methylcyclohexyl) phthalate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material:KN53200656
- Expiration date of the lot/batch: 2017-11-18
- Purity test date: 2017-02-13
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient, protected from light
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo, Netherlands
- Age at study initiation: 8 weeks
- Weight at study initiation: 18 - 21.2g
- Housing: single
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h/12h
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 10%, 50%, undilluted
- No. of animals per dose:
- 5
- Details on study design:
- Dose Selection Rational:
In a pre-test, two mice per group were treated with testsubstance concentrations of 10%, 50% and the undiluted test substance on three consecutive days.
Clinical signs were recorded after each application as well as on day 5. Signs of local irritation were recorded on day 1, 2 and 5. Prior to the first application of the test item (day 0), on day 2 and before sacrifice (day 5) the ear thickness was determined by using a micrometer. Furthermore, the ears were punched after sacrifice at the apical area by using a biopsy punch (Ø 0.8 cm) and were immediately pooled per animal and weighed by using an analytical balance. Additionally, the weight of the pooled lymph nodes from both sides was determined for each animal.
No signs of systemic toxicity were observed in the pretest. At the tested concentrations, the animals did not show relevant signs of local irritation as confirmed by determination of the ear weights (compared to current vehicle values) and ear thickness measurements. Slight swelling of the ear skin was noted at all concentrations tested, during the observation period. Very slight erythema was observed in the animals, treated with the undiluted test substance from study day 1 up to study day 5. In addition, accumulation of test item with accompanying distinct erythema (head- back region) was noted after application of the undiluted test substance on study day 2 and 5. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- EC3
- Value:
- 29.4
- Cellular proliferation data / Observations:
- SI
10%: 1.35
50%: 4.75
100%: 8.17
Lymph node cell counts
10%: 1.42
50%: 2.01
100%: 2.59
Lymph node weight
10%: 1.16
50%: 1.59
100%: 2.01
Any other information on results incl. tables
The test-substance concentrations did not cause biologically relevant increases (SI > 1.25) in ear weights demonstrating the absence of relevant ear skin irritation. However, a statistically significant increase in ear weights was noted at 50% (+5%) and 100% (+13%).
Slight swelling of the ear skin was observed in all test-substance treated animals, while severe adhesion of the test item producing distinct erythema (head/shoulder/neck region) was noticed after application of the 50% test-substance preparation and of the undiluted test substance, on study day 1 and/or 2, only.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
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