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EC number: 201-557-4 | CAS number: 84-74-2
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-Studie (GLP, QAU)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- Only clinical signs, mortality and pathology/histopathology (histotechnical processed and a cytochemical presentation of peroxisomes with diaminobenzidine in the hepatocytes of the liver was performed in semi-thin sections)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dibutyl phthalate
- EC Number:
- 201-557-4
- EC Name:
- Dibutyl phthalate
- Cas Number:
- 84-74-2
- Molecular formula:
- C16H22O4
- IUPAC Name:
- dibutyl phthalate
- Details on test material:
- - Name of test material (as cited in study report): dibutyl phthalate (test substance number 89/449)
- Analytical purity: > 99% (GC)
- Lot/batch No.: P .66 A/89
- Other: positive control substance (name as cited in study report: bis-[2-ethylhexyl] phthalate [test substance number 89/588]; analytical purity: > 99.5% [GC]; lot/batch No.: P .144 A/89, B .63A)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: male and female Wistar rats (Chbb = THOM, SPF) used were from Dr . Karl Thomae GmbH, Biberach/Riss, FRG, and clinically free from any signs of disease
- Age at study initiation: 35 days at supply
- Housing: during the study period the rats were housed singly in type DK III stainless steel wire mesh cages, supplied by BECKER & CO., Castrop-Rauxel, FRG (floor area about 800 cm2)
- Diet (e.g. ad libitum): the feed used was ground KLIBA rat/mouse/hamster maintenance laboratory diet GLP 343 meal of KLINGENTALMÜHLE AG, CH-4303 Kaiseraugst
- Water (e.g. ad libitum): drinking water
- Acclimation period: 7-day
ENVIRONMENTAL CONDITIONS
The animals were accommodated in a fully air-conditioned room
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test substance preparations were prepared by weighing in the test substance and mixing this thoroughly with a small amount of the feed. This was then mixed in a BOSCH household mixer. An appropriate amount of feed was then added to obtain the desired concentration, and mixing was carried out for about 10 minutes in a GEBR. LÖDIGE laboratory mixer. Different amounts of DIBUTYL PHTHALATE and Bis-(2-ethylhexyl)- phthalate were added, depending on the test groups to the feed at the end of the adaptation period
DIET PREPARATION
- Rate of preparation of diet (frequency): the test substance preparations were prepared in up to 2-week intervals for reasons of the confirmed stability over 32 days. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The analytical results verified the correctness of the test substance concentrations in the diet with two exceptions.
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- continuously via food
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
ca. 30, 152, 752 mg/kg bw per day
Basis:
other:
- Remarks:
- Doses / Concentrations:
0, 400, 2000 and 10000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- 3 (see Table 1)
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: the doses were chosen on the basis of the 28-day feeding study with test substance and positive control substance carried out at BIBRA, in which concentrations of 0.02, 0.05, 0.1, 0.5, 1.0 and 2.59 in the diet were used. According to preliminary results, the no effect level of test substance was at 0.1 % and of positive control substance is at 0.05%, which is possibly equivalent to a respective test substance intake of about 100 and 50 mg/kg body weight. Due to the above mentioned findings dose levels for test substance of 400, 2000 and 10000 ppm and for positive control substance 1400 ppm were chosen. The study was carried out from August 29, 1989 (day 0) to December 07, 1989 (last day of perfusion fixation).
- Rationale for selecting satellite groups: no satellite group used - Positive control:
- Bis-(2-ethylhexyl)- phthalate in a dosage of 1,400 ppm via the diet over 3 months as a positive control group in respect to the number and morphology of the liver peroxisomes
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: a check for dead and moribund animals was carried out twice a day (Mondays to Fridays) or once a day (Saturdays, Sundays and on public holidays).
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: the animals were inspected for evident signs of toxicity twice a day (Mondays to Fridays) or once a day (Saturdays, Sundays and on public holidays). In addition, the animals were also subjected to an additional exact clinical examination once a week. - Sacrifice and pathology:
- At the end of the study the animals were sacrificed by perfusion fixation followed by gross-pathological assessment. From all animals the liver was removed, histotechnical processed and a cytochemical presentation of peroxisomes with diaminobenzidine in the hepatocytes of the liver was performed in semi-thin sections.
- Other examinations:
- None
- Statistics:
- None
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
- The administration of the test substance and Bis-(2-ethylhexyl)-phthalate as addition to the diet in different dosages did not lead to any disturbances of the general state in any test animal
- During the entire administration period no animal died prematurely.
GROSS PATHOLOGY AND HISTOPATHOLOGY: NON-NEOPLASTIC
At the end of the study the animals were sacrificed by perfusion fixation followed by gross-pathological assessment. From all animals the liver was removed, histotechnical processed and a cytochemical presentation of peroxisomes with diaminobenzidine in the hepatocytes of the liver was performed in semi-thin sections.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 152 mg/kg bw/day (nominal)
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Effect level:
- 752 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: LOAEL based on peroxisomal proliferation
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.
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