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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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 December 1979 to 8 February 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline is available for the conduct of skin irritation testing in humans
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Shelanski HA and Shelanski MD (1953). A new technique of human patch tests. Proceedings of the Scientific Section of the Toilet Goods Association, No. 19, 46-49.
Substance applied to a patch of at least 6.5 square cm for 24 hr on 3 days/week for a total of 5 weeks, allowing the skin to recuperate for 24 hr between exposures. This method was reported to detect not only primary irritants but also cumulative irritants. - GLP compliance:
- 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
- Substance type: no data
- Physical state: liquid
- Analytical purity: > 99.9%
- Impurities (identity and concentrations): benzyl chloride 1.3 ppm; benzal chloride 4.8 ppm
- Composition of test material, percentage of components:
- Purity test date: 12 October 1979
- Lot/batch No.: DK 788
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Test animals
- Species:
- other: 200 human subjects completed the single dose study (out of 208 that started it)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 ml
- Concentration (if solution): 100%; undiluted
VEHICLE
none - Duration of treatment / exposure:
- Three times weekly for 24 hr each application on alternate weekdays for 3 weeks, then a 2-week break (during Christmas period) followed by a further 2 weeks of the same thrice-weekly applications.
- Observation period:
- Examined for signs of irritation on removal of each patch and 24 hr later.
- Number of animals:
- 200 human subjects completed the single dose study (out of 208 that started it)
- Details on study design:
- TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: Parke-Davis Readi-Bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
SCORING SYSTEM: Reactions judged by the investigators to be due to the test substance and not, for example, to the adhesive dressing were scored as follows:
? - questionable change
1/2 - mild erythema covering less than half of the contact site
1 - erythema confined to the contact site which exceeds that of the untreated skin
2 - erythema confined to the contact site which definitely exceeds that of the untreated skin, with or without papules
3 - erythema, with some skin hardening, with or without papules
4 - erythema, skin hardening, with one or more complications, such as extension beyond the margins of the contact area, vesiculation or ulceration
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Remarks:
- 0
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Remarks on result:
- no indication of irritation
- Remarks:
- 0 and 24 hr after patch removal, repeated on alternate weekdays for 5 weeks
- Irritation parameter:
- erythema score
- Remarks:
- 0
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Remarks on result:
- no indication of irritation
- Remarks:
- 0 and 24 hr after patch removal, repeated on alternate weekdays for 5 weeks
- Irritant / corrosive response data:
- No irritant or corrosive responses
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Santicizer 160 (butyl benzyl phthalate) showed no irritating potential when applied to the skin of 200 human volunteers in a repeated-dose patch test.
- Executive summary:
Santicizer 160 (butyl benzyl phthalate) was assessed for its potential to cause skin irritation in humans using a repeated insult patch test method.
During the induction phase 200 healthy volunteers were exposed to 0.2 ml of the undiluted test substance applied to an occlusive patch for 24 hours on fifteen separate occasions. The skin was assessed for irritation after each induction exposure.
No evidence of irritation (or sensitization) was observed by the investigators or reported by any of the volunteers during the study.
Santicizer 160 (butyl benzyl phthalate) showed no skin irritation potential in healthy human subjects in a repeated insult patch test.
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