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EC number: 236-400-9 | CAS number: 13351-61-6
- 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:
- 1981-08-31 to 1981-10-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Equivalent to OECD guideline 406, no GLP study, unclear if highest non irritating dose was used. Only 20 % mixture in peanut oil was tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 2,2-dimethyl-3-phenylpropanol
- EC Number:
- 236-400-9
- EC Name:
- 2,2-dimethyl-3-phenylpropanol
- Cas Number:
- 13351-61-6
- Molecular formula:
- C11H16O
- IUPAC Name:
- 2,2-dimethyl-3-phenylpropan-1-ol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchtstierzucht, Hagemann GmbH & Co. KG, Hamelner Straße 3, 4923 Exertal
- Weight at study initiation: 250 g (mean weight)
- Housing: Macrolon cages III, height: 14 cm, width: 25 cm, length: 42 cm
- Diet: Ssniff-G, pellets
- Water: ad libitum, tap water
- Acclimation period: ca 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/-2
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12, light from 7 am to 7 pm
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 0.5 mL
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 0.5 mL
- No. of animals per dose:
- 20 females test group
10 females control group - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test group: 20 test animals were treated once a week for the duration time of 3 weeks on the clipped left side with the test substance.
- Control group: 10 animals were treated only with the vehicle in a similar manner to that used for the treated group.
- Site: Clipped left side
- Frequency of applications: every week
- Duration: 3 weeks
- Concentrations: 0.5 mL in a 20 % mixture in peanut oil.
B. CHALLENGE EXPOSURE (14 days after the last induction exposure)
- No. of exposures: 3
- Exposure period: 6 hours
- Test group/ Control group: Both groups are treated with the test substance on the right side of the animals.
- Site: Right side
- Concentrations: 0.5 mL in a 20 % mixture in peanut oil.
- Evaluation (hr after challenge): Right side was depilated after 24 hours, evaluation after 2 hours, 24 and 48 hours - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 mL
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 mL
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The skin sensitizing potential of the test item was tested in the Buehler Test, using 20 % of the test substance in peanut oil. No sensitizing potential was found under the test conditions.
- Executive summary:
The skin sensitizing potential of the test item was tested in the Buehler Test, using 20 % of the test substance in peanut oil. A sensitization study was conducted using white Pirbright guinea pigs weighing approx. 250 gm at the start of the study. Animals were housed 2/cage in macrolon plastic cages. Bedding was from pure spuce-, fir- or pine-wood, dried and disdusted. Fluorescent lighting was on 12 hr daily, temperature was 21 C, and relative humidity, 45 to 55%. Food and water was provided ad libitum. After an acclimatization period of 7 days, animals were divided into two groups of 20 female animals (test group) and 10 female animals (control group). Prior to treatment, the left shoulder of each animal was clipped with a small animal clipper (about 8 x 5 cm). 0.5 mL of the test substance was applied undiluted to a 2 x 2 cm gauze pad. The patches were placed on the clipped left shoulder of each animal of the test group and secured with a wrapping of Elastoplast. Then the animals were immobilized in restrainers for 6 hours. After that time the patches were taken off. The procedure was repeated at the same side once weekly during the next two weeks for a total of three 6 hr exposures. After the last induction exposure, the animals were left untreated for 2 weeks before primary challenge. The animals previously exposed during the induction period as well as the previously untreated control animals were treated following the same patching procedure as for induction but the patches were applied to the freshly clipped right side that has not been treated before. 24 hours after the primary challenge all animals were depilated on the right side. The test sites were graded 6, 24 and 48 hours after the depilation by comparing the treated test animals with the animals of the control group. Any signs of erythema and other lesions were recorded. No skin sensitizing potential was observed during the study.
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