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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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
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Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, reasonably well-documented publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Dermal absorption of phthalate diesters in rats
- Author:
- Elsisi AE, Carter DE & Sipes IG
- Year:
- 1 989
- Bibliographic source:
- Fundamental and Applied Toxicology, 12, 70-77
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 427 (Skin Absorption: In Vivo Method)
- Deviations:
- yes
- Remarks:
- (only 3 animals tested (guideline recommends 4); only 1.3 cm2 skin area of application (guideline recommends 10 cm2); expired air not collected; some omissions in reporting but no indication whether or not these related to omissions in practice)
- GLP compliance:
- not specified
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): benzyl butyl phthalate (BBP)
- Substance type: laboratory reagent
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data; non-radioactive BBP obtained from Pfaltz and Bauer, Inc., Research Chemicals Division, Stamford, CN, USA; radioactive BBP obtained from Midwest Research Institute, Kansas City, KS, USA
- Expiration date of the lot/batch: no data
- Radiochemical purity (if radiolabelling): >96%
- Specific activity (if radiolabelling): no data
- Locations of the label (if radiolabelling): ring
- Expiration date of radiochemical substance (if radiolabelling): no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: no data
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Division of Animal Resources of the University of Arizona Health Sciences Center
- Age at study initiation: no data
- Weight at study initiation: 180-220 g
- Fasting period before study: no data
- Housing: no data
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): Purina Lab Chow, ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: no data
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- ethanol
- Duration of exposure:
- 7 days
- Doses:
- - Nominal doses: 157 µmol/kg bw (49 mg/kg bw ) at 40 µCi/kg bw
- Actual doses: 7.7 mg/cm2
- Actual doses calculated as follows: applied to a circular area of 1.3 cm internal diameter, i.e. area of 1.3 cm2; at a body weight of 200 g, total dose ~10 mg; 10/1.3 = 7.7 mg/cm2
- Dose volume: no data
- Rationale for dose selection: 0.01x oral/intraperitoneal LD50 - No. of animals per group:
- 3
- Control animals:
- no
- Details on study design:
- DOSE PREPARATION
- Method for preparation of dose suspensions: no data
- Method of storage: no data
APPLICATION OF DOSE:
VEHICLE
- Justification for use and choice of vehicle (if other than water): no data
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): no data
- Lot/batch no. (if required): no data
- Purity: USP grade
TEST SITE
- Preparation of test site: middle of back clipped using electric clipper 1 hour prior to application of test material
- Area of exposure: 1.3 cm2
- % coverage: no data
- Type of cover / wrap if used: no dressing or wrap (but see 'site protection' below)
- Time intervals for shavings or clipplings: once, single application
SITE PROTECTION / USE OF RESTRAINERS FOR PREVENTING INGESTION: yes
- site protection: skin covered by circular plastic cap with an internal diameter of 1.8 cm, perforated with 10 needle holes to allow aeration, secured with Krazy-Glue cyanoacrylate glue
- restrainers: thick-walled rubber tubing wrapped around chest behind front legs and around abdomen in front of hind legs; held in place with wire placed through centre of tubing; animal could walk freely and access food and water, but could not twist its body or wipe or lick its back
REMOVAL OF TEST SUBSTANCE
- Removal of protecting device: 7 days
- Washing procedures and type of cleansing agent: not required
- Time after start of exposure: 7 days
SAMPLE COLLECTION
- Collection of blood: at study termination only
- Collection of urine and faeces: yes
- Collection of expired air: no
- Terminal procedure: necropsy
- Analysis of organs: brain, spinal cord, lung, liver, spleen, intestine, kidney, testis, fat, muscle, skin (from area of application and a distant site)
SAMPLE PREPARATION
- Storage procedure: no data
- Preparation details:
- Urine: pH adjusted to 4.5-5.5 using glacial acetic acid
- Faeces: digested in 0.5 N NaOH, sample air dried and combusted in a sample oxidizer
- Tissues: samples air dried for 24 hours and combusted
- Skin from area of application: digested in 2 M KOH/methanol; aliquot adjusted to pH 4.5-5.5 with glacial acetic acid
- Plastic cap: washed with 95% ethanol
ANALYSIS
- Method type(s) for identification: Liquid scintillation counting
- Liquid scintillation counting results (cpm) converted to dpm as follows: no data (radioactivity presented as 14C-equivalents)
- Validation of analytical procedure: no data
- Limits of detection and quantification: no data
OTHER:
- Data analysis: one-way analysis of variance, Student's t-test, level of significance p<0.05
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- not specified
- Absorption in different matrices:
- Mean (+- SD) % of dose in 14C-equivalents 7 days after application to the skin:
- Non-occlusive cover + enclosure rinse: 6.3 (+- 0.8) %
- Skin wash: not done
- Skin test site: 44.9 (+- 6.2) %
- Skin, untreated site: 0.08 (+- 0.03) %
- Blood: no separate data (see 'other tissues' below)
- Carcass: no data
- Urine: no separate data; urine and faeces combined: 30% excreted by 7 days
- Cage wash + cage wipe: not done
- Faeces: see urine
- Expired air (if applicable): not done
- Serial non-detects in excreta at termination: no data
- Other:
- adipose tissue: 0.17 (+- 0.08) %
- muscle: 4.6 (+- 3.7) %
- 'other tissues' (summation of brain, lung, liver, spleen, small intestine, kidney, testis, spinal cord and blood): <0.5% - Total recovery:
- - Total recovery: 86 (+- 2) % (sum of percentage dose found in urine, faeces, tissues and plastic cap in 7 days)
- Recovery of applied dose acceptable: no data
- Results adjusted for incomplete recovery of the applied dose: no data
- Limit of detection (LOD): no data
- Quantification of values below LOD or LOQ: no data
Percutaneous absorption
- Dose:
- 49 mg/kg bw (7.7 mg/cm2)
- Parameter:
- percentage
- Absorption:
- ca. 35 %
- Remarks on result:
- other: 7 days
- Remarks:
- 30% of dose excreted in urine and faeces, 4.6% recovered from muscle, 0.17% from adipose tissue, <0.5% from brain, spinal cord and testis, and 0.08% from skin distant from the application site.
- Conversion factor human vs. animal skin:
- no data
Applicant's summary and conclusion
- Conclusions:
- Covered application of 14C-benzylbutylphthalate on the shaved skin of rats (to an area of 1.3 cm2) at 49 mg/kg bw (7.7 mg/cm2) for 7 days resulted in approximately 35% dermal absorption over this period, equivalent to 5% per day.
- Executive summary:
In a reliable dermal absorption study, 14C-labelled benzylbutylphthalate was applied to the shaved skin of three male rats at a dose of 49 mg/kg bw on an area of 1.3 cm2. The application was semi-occluded for 7 days during which time urine and faeces were collected. At study termination, samples of a number of tissues were taken. Radioactivity was determined in all these tissues and excreta.
The proportion of the administered dose found in the tissues and excreta after 7 days was
30% in urine and faeces, 4.6% in muscle, <0.5% in brain, spinal cord and testis, 0.17% in adipose tissue and
0.08% in skin distant from the application site, making a total of about 35%. Total recovery (including site of application and covering) was 86%.Covered application of 14C-benzylbutylphthalate on the shaved skin of rats (to an area of 1.3 cm2) at 49 mg/kg bw (7.7 mg/cm2) for 7 days resulted in approximately 35% dermal absorption over this period, equivalent to 5% per day.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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