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EC number: 279-576-2 | CAS number: 80858-47-5
- 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)
- Remarks:
- Test is performed before October 2016 when the REACH regulation came into force requesting in vitro studies first
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 January - 7 March 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Reliability 2 is assigned because although the study was conducted similar to the OECD TG 406, the guideline is not referenced, also because the official guideline was established 2 months after the report of this study was completed. However, it is assumed that the authors of the report / study director followed a draft version of this guideline, which resulted in a study similar to the current OECD TG 406. Therefore, this did not influence the reliability of the results. Except for this, this study is probably non-GLP. Additionally, a diluent which was used to dilute the test substance for testing is unknown, as well as the positive control used. This is not expected to influence the positive results of this study.
- Justification for type of information:
- Test is performed before October 2016 when the REACH regulation came into force requesting in vitro studies first.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1981)
- Deviations:
- yes
- Remarks:
- The study has a number of limitations and deviations. The test substance was diluted with an unknown diluent. This is not expected to influence the positive results of this study. An unknown positive control was used.
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The skin sensitisation information is available before the LLNA guideline was initiated.
Test material
- Reference substance name:
- [2-(cyclohexyloxy)ethyl]benzene
- EC Number:
- 279-576-2
- EC Name:
- [2-(cyclohexyloxy)ethyl]benzene
- Cas Number:
- 80858-47-5
- Molecular formula:
- C14H20O
- IUPAC Name:
- [2-(cyclohexyloxy)ethyl]benzene
- Test material form:
- liquid
1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- albino strain
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS:
- Source: Murphy Breeding Laboratories
- Age at Acclimatization Start: No information provided
- Weight at Acclimatization Start: 300-400 g
- Housing: individually in wire mesh cages, suspended above the droppings
- Diet: Purina Guinea Pig Chow was available ad libitum throughout the study
- Water: First, the animals were maintained on medicated water containing 4% of sulfaethoxypyridazine for four days. At the end of this period, they were furnished with non-medicated water ad libitum.
- Acclimation period: at least one week.
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): No information provided
- Humidity (%): No information provided
- Air changes (per hr): No information provided
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- Test substance was used at 3% in the amount of 0.4 ml.
- Day(s)/duration:
- The exposure was done for 6-6.5 hours once each week for three weeks.
- Adequacy of induction:
- other: Concentration causing a very mild irritation
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- Test substance was used at 3% in the amount of 0.4 ml.
- Day(s)/duration:
- The exposure was done for 6 and one-quarter hours.
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test animals: 15
Control animals: 15 (10 used as positive controls and 5 as negative controls) - Details on study design:
- RANGE FINDING TESTS
- Topical application:
Prior to the induction phase of the study, the test material was applied to four additional guinea pigs to determine the highest non-irritating concentration which could be applied for the inductions and the primary challenge. For this purpose, the test substance was tested as 25%, 12.5%, 6.0% and 3.0% v/v solutions in the diluent. On the day before applications, the backs of the guinea pigs were clipped with electric clippers. This provided space to test four concentrations on each guinea pig. On the following day, a patch was applied for six hours to each animal using 0.4 ml of each test solution.
On the day following application, the clipped areas were depilated with Neet Cream Hair Remover. The depilatory was allowed to remain on the sites for 30 minutes and then washed off with warm tap water. The patch sites were scored for irritation approximately five hours later.
MAIN STUDY
A. INDUCTION EXPOSURE
Topical applications
- Concentration: 3.0%
- Amount: 0.4 ml
- Area: 4 cm2
- Exposure length: 6-6.5 hours (occlusive)
- Exposure period: the patches were reapplied to the same site once each week for a total of three applications.
B. CHALLENGE EXPOSURE (control and test group)
- Day of challenge: 2 weeks after the epidermal induction application
- Concentration of test substance: 3.0% (amount: 0.4 ml)
- Concentration of the positive control: 0.1% w/v solution (amount: 0.4 ml)
- Negative control: 100% diluent (amount: 0.4 ml)
- Exposure period: 6 and one-quarter hours (occlusive)
- Sites: fresh application site, different from the induction site, the lower left quadrant of the backs of animals
- Readings: 24 and 48 hours after patch removal. - Challenge controls:
- The positive controls received 0.4 ml of the positive control substance as a 0.1% w/v solution in the diluent, and the negative controls received 0.4 ml of 100% diluent. The exposure time and technique was as described for the animals receiving the test substance.
- Positive control substance(s):
- yes
- Remarks:
- A positive control was used in this study, however the identification of this substance is not given.
Results and discussion
- Positive control results:
- For the positive control animals, two scores of 2, five scores of 1, and three scores of +/- were noted at the 24-hour reading and six scores of 1, three scores of +/- and one score of 0 were noted at the 48-hour reading.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3.0%
- No. with + reactions:
- 8
- Total no. in group:
- 15
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3.0%
- No. with + reactions:
- 8
- Total no. in group:
- 15
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Irritative effects noted during the pilot test of the test substance included two scores of 1 and two scores of +/- as a 25% v/v solution, two scores of 1 and two scores of +/- as a 12.5% v/v solution, two scores of 1, one score of +/- and one score of 0 as a 6.0% v/v solution and two scores of +/- and two scores of 0 as a 3.0% v/v solution. Based upon the results of the pilot test, a concentration of 3.0% v/v was selected as the concentration to be used for the induction and challenge of the test animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin sensitising (Category 1B)
- Remarks:
- According to EU CLP 1272/2008 and its amendments.
- Conclusions:
- In a guinea pig Buehler test performed similar to OECD 406 (1981), the substance is considered a skin sensitiser.
- Executive summary:
The skin sentisation potential of the substance was investigated by performing a guinea pig Buehler test similar to OECD 406 (1981). Fifteen albino guinea pigs (males and females) were used. A concentration of 3% was used for the topical induction and for the challenge as the highest non-irritating concentration, based on the previous range finding test. At the both 24-hour and 48-hour readings, the test substance group showed a reaction in 8 out of 15 animals. This result is in the range for 1B sensitizer classification: between 15 and 60% of animals responding at a dose between 0.2 and 20%. Based on the results of the present study, the substance is considered to be a skin sensitiser. Despite the concentration not being an irritant during the induction, the results are acceptable in view of the sensitization seen.
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