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Diss Factsheets
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EC number: 201-622-7 | CAS number: 85-68-7
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Only brief summary data and results table available.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In an acute dermal toxicity study, the test material was applied to the skin of rabbits at one of three doses, and animals assessed for toxic symptoms.
- GLP compliance:
- no
- Test type:
- other:
- Limit test:
- no
Test material
- Reference substance name:
- Benzyl butyl phthalate
- EC Number:
- 201-622-7
- EC Name:
- Benzyl butyl phthalate
- Cas Number:
- 85-68-7
- Molecular formula:
- C19H20O4
- IUPAC Name:
- 1-benzyl 2-butyl benzene-1,2-dicarboxylate
- Details on test material:
- - Name of test material (as cited in study report): Santicizer 160
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Lot/batch No.: QE-29401
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.0-2.2 kg
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- No data
- Duration of exposure:
- 24 hours
- Doses:
- 3.98, 6.31 and 10.0 g/kg bw
- No. of animals per sex per dose:
- One male was tested at 3.98 g/kg bw, one female at 6.31 g/kg bw, and one male and one female at 10.0 g/kg bw
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopic evaluation - Statistics:
- no data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Mortality:
- All four animals survived the 14-day observation period
- Clinical signs:
- other: Reduced appetite and activity seen for two to four days (number of animals and doses not given)
- Gross pathology:
- The viscera of the survivors appeared normal following macroscopic examination
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There were no deaths when four rabbits (2/sex) were given a 24-hour skin application of undiluted Santicizer 160 at up to 10.0 g/kg bw and then observed for 2 weeks. Although details of the study are only available in a brief summary report (hence it has been assigned reliability code 4), the data are considered adequate for assessment.
- Executive summary:
Undiluted Santicizer 160 was applied to the skin of four New Zealand white rabbits. One male was dosed at each of 3.98 and 10.0 g/kg bw, and one female dosed at each of 6.31 and 10.0 g/kg bw, for an exposure period of 24 hours (no further details given on exposure conditions). The animals were assessed for toxic symptoms during the observation period, and the animals were sacrificed 14 days after dosing and examined macroscopically.
All four animals survived the 14-day observation period. Reductions in appetite and activity were seen for 2 -4 days (no details provided on the doses at which these effects were seen). At necropsy, the viscera appeared normal. The investigators concluded that the LD50 was greater than 10.0 g/kg bw. Under the EU CLP regulations, this study would indicate that Santicizer 160 should not be classified for acute dermal toxicity.
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