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EC number: 284-863-0 | CAS number: 84988-74-9
- 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:
- chronic toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 1953
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable published study, basic data given (analytical purity of test substance not specified, only limited parameters evaluated (no clinical chemistry, urinalysis, behavioral examinations), limited documentation).
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Toxicity of butyl stearate, dibutyl sebacate, dibutyl phthalate, and methoxyethyl oleate
- Author:
- Smith, C.C.
- Year:
- 1 953
- Bibliographic source:
- Arch Ind Hyg Occup Med 7(4): 310-318
- Reference Type:
- secondary source
- Title:
- Final report on the safety assessment of Butyl stearate, Cetyl stearate, Isobutyl stearate, Isocetyl stearate, Isopropyl stearate, Myristyl stearate, and Octyl stearate
- Author:
- Busch J.T.
- Year:
- 1 985
- Bibliographic source:
- J Am College of Toxicol 4: 107-146
- Reference Type:
- secondary source
- Title:
- Palmitic Acid 2-ethylhexyl Esters Category of the Aliphatic Esters Chemicals (Test Plan and Robust Summaries for Substances in the HPV Test Plan)
- Author:
- US-EPA (American Chemistry Council’s Aliphatic Esters Panel)
- Year:
- 2 010
- Bibliographic source:
- High Production Volume (HPV) Chemical Challenge Program (201-16834B and 201-14977E)
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of male Sprague-Dawley rats were treated with the test item offered via feed during 2 years. 16 animals per dose level were used. The tested dose levels were 0.01, 0.05, 0.25, 1.25 and 6.25%, but only data of the 2 highest dose levels were considered for reporting.
- GLP compliance:
- no
Test material
- Reference substance name:
- Butyl stearate
- EC Number:
- 204-666-5
- EC Name:
- Butyl stearate
- Cas Number:
- 123-95-5
- Molecular formula:
- C22H44O2
- IUPAC Name:
- butyl stearate
- Details on test material:
- - Name of test material (as cited in study report): Butyl stearate
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 65-66 g
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- continously in diet
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1.25 and 6.25%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
2500 and 6000 mg/kg bw/day
Basis:
other: (corresponding daily doses)
- No. of animals per sex per dose:
- 16
- Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: Body weights were measured twice weekly during the first month, thereafter at weekly intervals.
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food intakes were measured twice weekly during the first month, thereafter at weekly intervals.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: In the interval between 1 and 2 years, animals were killed whenever they approached a state of debility which suggested that death might be imminent. In such cases smears of peripheral blood and bone marrow were examined. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, in the interval between 1 and 2 years, animals were killed whenever they approached a state of debility which suggested that death might be imminent. In such cases the following organs were subjected to gross pathological examination: portions of the lungs, heart, liver, spleen, adrenals, kidneys, stomach, small intestine, thyroid, and brain.
HISTOPATHOLOGY: Yes, sections of various organs were prepared from the sacrificed animals mentioned above, for microscopical examination. Therefore, heart, spleen, adrenals, stomach, small intestine, thyroid, and brain were fixed in formalin, sectioned from paraffin, and stained with hematoxylin and eosin.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- slight changes in ratio of types of leucocytes in both, control and treated animals (non adverse)
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- non adverse
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- non adverse
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No significant differences were observed between treated and control groups.
BODY WEIGHT AND WEIGHT GAIN
No substance related effects were observed.
HAEMATOLOGY
As the animals increased in age, slight changes in distribution of leucocytes were found, but these trends occurred in both the control and the treatment groups.
GROSS PATHOLOGY
Following gross pathology lesions were observed in animals killed at various time points during the experiment: acute and chronic inflammatory changes in the lungs, nephrosis in which the kidneys were enlarged and tan in colour, and fatty changes in the liver. Further pathological changes, such as tumors, infections of the ear and preputial glands, and an arteritis similar to periarteritis nodosa, occurred less frequently. These changes were found primarily in older animals.
HISTOPATHOLOGY: NON-NEOPLASTIC
Heart muscle, stomach, spleen, small intestine, bladder, thyroid, and adrenal gland exhibited only minor and insignificant changes. In lungs, liver, and kidneys, pathologic changes were observed frequently. The lesions of the lungs were for the most part typical of the chronic rat pneumonia described by Saxton et al. (1941) and others in old rats. The principal finding in the liver was fatty infiltration, usually diffuse in distribution; occasionally necrosis of the hepatic cells surrounding a central vein was seen. Chronic nephrosis were found in some rats. These lesions also were as described by Saxton et al. (1941) in old rats.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 6 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: no treatment-related effects were observed.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1: Hematologic findings
% test substance in diet |
Erythrocytes x 106/Cu. Mm. |
Hemoglobin g/100 mL |
Leucocytes x 106/Cu. Mm. |
0.00 |
7.4 ± 0.5 |
14.8 ± 0.8 |
7.8 ± 1.2 |
1.25 |
7.2 ± 0.5 |
14.2 ± 0.9 |
8.1 ± 1.9 |
6.25 |
7.6 ± 0.7 |
14.2 ± 1.4 |
7.9 ± 1.3 |
% test substance in diet |
Leucocytes (%) |
|||||
Neutrophiles |
Lymphocytes |
Monocytes |
Eosinophiles |
|||
Non-segmented |
Segmented |
Total |
||||
0.00 |
1.0 |
23.6 |
24.6 |
71.0 |
3.1 |
1.4 |
1.25 |
1.2 |
24.6 |
25.8 |
70.2 |
2.5 |
1.5 |
6.25 |
1.3 |
23.1 |
24.4 |
72.5 |
2.4 |
0.8 |
Table 2: Incidences of pathologic lesions at necropsy
% test substance in diet |
Number of rats subjected to necropsy |
Number of rats affected |
|||||||
Gross pathologic lesions |
|||||||||
None |
Pneumonitis |
Renal Disease |
Preputial gland infection |
Ear infection |
Arteritis |
Tumors, all types |
Other |
||
0.00 |
16 |
3 |
9 |
6 |
3 |
1 |
1 |
2 |
3 |
1.25 |
15 |
2 |
7 |
4 |
3 |
1 |
1 |
0 |
1 |
6.25 |
16 |
3 |
6 |
7 |
5 |
3 |
3 |
2 |
2 |
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.