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Diss Factsheets
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EC number: 215-553-5 | CAS number: 1330-86-5
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 27 September - 07 November 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study with acceptable restriction. Sensory reactivity to stimuli, assessment of grip strength and motor activity assessment was not conducted.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Reference Type:
- secondary source
- Title:
- Dibutyl adipate CAS N°: 105-99-7
- Author:
- OECD
- Year:
- 1 996
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 4; Tokyo, Japan, 20-22 May 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for 28-Day Repeat Dose Toxicity Test of Chemicals (Japan)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- Sensory reactivity to stimuli, assessment of grip strength and motor activity assessment was not conducted.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Dibutyl adipate
- EC Number:
- 203-350-4
- EC Name:
- Dibutyl adipate
- Cas Number:
- 105-99-7
- Molecular formula:
- C14H26O4
- IUPAC Name:
- dibutyl adipate
- Details on test material:
- - Name of test material (as cited in study report): Dibutyl adipate
- Analytical purity: 99.8%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc., Yokohama, Japan
- Age at study initiation: 5 weeks
- Weight at study initiation: 131 - 155 g
- Fasting period before study: No
- Diet: MF by Oriental Yeast Co., Ltd., Itabashi-ku, Japan, ad libitum
- Water: filtered and UV-irradiated tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 5 mL/kg - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily, 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
20, 140 and 1000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 6 (main study)
6 (satellite control and high-dose groups) - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Post-exposure recovery period in satellite groups: 14 days
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once a week
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 7, 15, 21, 28 during treatment, days 35 and 42 during recovery time
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/animal/day: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Day 29 and 43
- Anaesthetic used for blood collection: Yes (Sodium thiopental)
- Animals fasted: No
- How many animals:
6 (main study)
6 (satellite control and high-dose groups)
- Examined parameters: red blood cell (RBC), hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), white blood cells (WBC), platelet count, prothrombin time (PT), activated partial thromboplastin time (APTT), differential count of leukocytes (neutrophils, eosinophils, basophils, monocytes, lymphocytes)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Day 29 and 43
- Animals fasted: No
- How many animals: 6 (main study)
6 (satellite control and high-dose groups)
- Examined parameters: total protein, albumin, albumin/globulin ratio (A/G ratio), blood urea nitrogen (BUN), creatinine, glucose, total cholesterol, triglycerides, alkaline phosphatase (ALP), alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, inorganic phosphor, Ca, Na, K, Cl
URINALYSIS: Yes
- Time schedule for collection of urine: 3 week after commencement of treatment
- Metabolism cages used for collection of urine: No
- Animals fasted: No
- Examined parameters: PH, protein, glucose, ketones, bilirubin, occult blood, urobilinogen - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes, control and high dose group - Statistics:
- Barlett's test, Dunett's test, Scheffe's test, Kruskal-Wallis test and chi-square test.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/day: Slight salivation was observed frequently in high dose group animals after administration (non-adverse).
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 1000 mg/kg bw/day: Slight salivation was observed frequently in high dose group animals after administration (non-adverse).
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
During treatment slight salivation was observed in males and females in 1000 mg/kg bw/day. This change disappeared during recovery period.
BODY WEIGHT AND WEIGHT GAIN
Body weight and weight gain was not affected by the treatment.
FOOD CONSUMPTION
Food consumption did not differ between the control and treatment groups.
HAEMATOLOGY
No treatment related effects were observed.
CLINICAL CHEMISTRY
No treatment related effects were observed.
URINALYSIS
No treatment related effects were observed.
ORGAN WEIGHTS
No treatment related effects were observed.
GROSS PATHOLOGY
No treatment related effects were observed.
HISTOPATHOLOGY: NON-NEOPLASTIC
No treatment related effects were observed.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: salivation (non-adverse)
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.
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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