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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981-11-09 to 1981-11-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable and well documented publication, probably technical pure quality was tested
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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
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
Test animals
- Species:
- rat
- Strain:
- other: BOR: WISW
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma Winkelmann, Versuchstierzucht, 4791 Borchen 1, Gartenstraße 300
- Weight at study initiation: Males: 162-190 g, females: 155-170 g
- Housing: Macrolon cages Typ III with maximal 5 rats
- Diet: Ssniff, Versuchtstierdiäten GmbH 4770 Soest/Westfalen
- Water: ad libitum, in Macrolon drinkbottles, 300 mL, Firma Becker & Co., 4620 Castrop Rauxel, tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2 °C
- Humidity (%): 45-55 %
- Photoperiod: Room was artificially lit from 7 am to 7 pm
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 8 x 5 cm
- Type of wrap if used: gauze pads and several wrappings of plastic material
REMOVAL OF TEST SUBSTANCE
- Washing: After treatment the backs of all animals were secured with gauze pads and several wrappings of plastic material for 24 hours. Thereafter the patches were removed with wet disposable gauze
- Time after start of exposure: after 24 hours
TEST MATERIAL
- Amount(s) applied: 15 mL/kg
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 15000 mg/kg bw (Value based on calculation with density (appx. 1 g/cm^3))
- No. of animals per sex per dose:
- 5 males and 5 females
Two groups: The animals back of group I was abraded with a clean clipper blade so as to penetrate the horny layer of the epidermis, but without causing bleeding. The animals back of group II was left intact. - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 2h, 4h, 24 h, 48 h, 72 h, 7 days, 14 days (clinical toxicological signs), 24 h, 3,7 and 14 days (skin alterations)
- Frequency of weighing: On day 0 and on day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Statistics:
- According to Draize et al.
Results and discussion
- Preliminary study:
- To determine the toxicity of the test item the following doses were tested in 2 rats per dose: 15, 10, 5, 2.5 and 1 mL/kg
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 15 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Value based on calculation with density (appx. 1 g/cm^3)
- Mortality:
- No mortality occured
- Clinical signs:
- other: No abnormalities observed
- Gross pathology:
- No abnormalities observed
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study was carried out to determine the acute dermal toxicity potential of the test item. No mortality occured. The LD50 was determined to be >15000 mg/kg bw.
- Executive summary:
The study was carried out on male and female rats to determine the acute dermal toxicity and the skin irritation potential of the test item.The study was conducted with albino Wistar animals that were collectively housed up to a maximum of 5 animals per cage (Macrolon type III). The room was artificially lit from 7 AM to 7 PM. The temperature was 21 ° C and relative humidity was 45-55%. Animals weighed 162-190 g (males) and 155-170 g (females) at the initiation of the study. After an acclimatization time of 7 days the test was initiated. Evaluation of clinical-toxicological signs was done individually at 2, 4, 24, 48, 72 h and 7 and 14 days postadministration of test compound. Any skin alterations were recorded at 24 h, 3, 7 and 14 days after application of test compound per Draize. Body weights were recorded on Day 0 and on Day 14. Immediately after death, a complete necropsy was performed on all acute- and late mortalities as well as on animals surviving the 14-day observation period. Prior to treatment the back of each animal was clipped (8 x 5 cm) with a small animal clipper. The animals back of group I was abraded with a clean clipper blade so as to penetrate the horny layer of the epidermis, but without causing bleeding. The animals back of group II was left intact. After treatment the backs of all animals were secured with gauze pads and several wrappings of plastic material for 24 hours. Thereafter the patches were taken off and the substance was removed with wet disposable gauze. Test compound was applied as supplied. The sample of test compound was weighed per animal and then dosed once dermal onto the scarified and intact skin, respectively, and thereafter secured as described above. No mortality occurred. The LD50 was determined to be >15000 mg/kg bw. Also no skin irritating potential was determined. An erythema score of 0 was determined. Also the edema score was 0.
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