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EC number: 278-717-5 | CAS number: 77538-19-3
- 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://chesar.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
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Docosanoic acid
- EC Number:
- 204-010-8
- EC Name:
- Docosanoic acid
- Cas Number:
- 112-85-6
- Molecular formula:
- C22H44O2
- IUPAC Name:
- docosanoic acid
- Details on test material:
- - Name of test material (as cited in study report): docosanoic acid
- Physical state: white powder
- Analytical purity: 85.9%
- Lot/batch No.: 60805X
- Impurities (identity and concentrations): C14-C20 fatty acids: 10.9%, C24 fatty acids: 2.3%
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan, Hino, Tokyo, Japan
- Age at study initiation: 8 weeks
- Weight at study initiation: 312.1 - 363.7 g (males); 205.3 - 230.8 g (females)
- Housing: metal wire floor cages
- Diet (ad libitum): CE-2, CLEA Japan
- Water (ad libitum): tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 1
- Humidity (%): 50 - 65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: dosing solutions were prepared more frequently than once a week; aliquots of each concentration were kept refrigerated in airtight conditions.
VEHICLE
- Justification for use and choice of vehicle (if other than water): due to the insolubility in water, corn oil was selected as appropriate vehicle
- Amount of vehicle (if gavage): 5 mL/kg bw
- Lot/batch no. (if required): V6H2050 - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- - males: 42 days
- females: 14 days prior to mating to day 3 of lactation - Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300, 1000 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 13
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on a preliminary 14 day-repeated dose toxicity study, where no signs of toxicity were found
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least once a day
BODY WEIGHT: Yes
- Time schedule for examinations: males: day 1, 8, 15, 22, 29, 36 and 42; females: premating day 1, 8 and 15; pregnancy day 0, 7, 14 and 20; lactation day 0 and 4
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
HAEMATOLOGY: Yes (males only)
- Time schedule for collection of blood: prior to autopsy
- Anaesthetic used for blood collection: Yes (identity): pentobarbital sodium
- Animals fasted: 18 - 24 h before sacrifice
- How many animals: all surviving animals
- Parameters checked: red blood cell count (RBC), white blood cell count (WBC), haemoglobin content (Hb), mean corpuscular volume (MCV), haematocrit (Ht), mean corpuscular haemoglobin content (MCH), mean corpuscular haemoglobin concentration (MCHC)
CLINICAL CHEMISTRY: Yes (males only)
- Animals fasted: 18 - 24 h before sacrifice
- How many animals: all surviving animals
- Parameters checked: total protein, albumin, total cholesterol concentration, glucose, urea nitrogen, creatinine, alkaline phosphatase activity (ALP), glutamate-oxalacetate-transaminase (GOT), glutamate pyruvate transaminase (GPT), gamma-glutamyl transpeptidase (γ-GTP), triglyceride concentration, inorganic phosphorus, total bilirubin, calcium, sodium, potassium, chlorine, albumin/globulin ratio (A/G ratio)
URINALYSIS: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Organ weights:
male: heart, liver, kidneys, thymus, testes, epididymides
female: heart, liver, kidneys, thymus
HISTOPATHOLOGY: Yes (control and 1000 mg/kg bw /day group):
male: heart, liver, spleen, kidneys, adrenal, testes, epididymis, brain, thymus, bladder
female: brain, liver, spleen, thymus, kidneys, adrenals, bladder, heart, ovaries - Statistics:
- Yates-test, Mann-Whitney-U-test, Fisher exact-test, Bartlett-test, Dunnett-test, Scheffe-test, Kruskal-Wallis-test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 100 mg/kg bw/d: increased body weight of males (non-adverse)
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- 100 mg/kg bw/day (females): significant reduced food consumption during lactation (non-adverse); 100 mg/kg bw/day (males): increased food consumption
- Food efficiency:
- no effects observed
- 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):
- 300 and 1000 mg/kg bw/d: significant decrease of mean corpuscular haemoglobin concentration in males (non-adverse)
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- all dose groups: sporadic effects on glucose, total protein, calcium, ALP (non-adverse)
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- 100 mg/kg bw/d: significant liver weight increase in males and signficant decrease in kidney weights in females (non-adervse)
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- all dose groups: sporadic effects on adrenal gland, thyroids, thymus, lung, liver, kidney and spleen in males and females (non-adverse)
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/d: sporadic findings in brain, heart, liver, spleen, kidney, adrenals, thymus and testes in males and females (non-adverse)
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No mortality and no clinical signs were observed.
BODY WEIGHT AND WEIGHT GAIN
Body weight gain in male animals of the 100 mg/kg bw/day group was higher when compared to the 300 and 1000 mg/kg bw/day dose groups and to the control group (10-33%) over the whole treatment period. Since this effect showed no dose-relation and no other effects of toxicity were observed in this dose group, it was regarded as non-adverse.
FOOD CONSUMPTION
Food consumption of males of the 100 mg/kg bw dose group was about 4-10% increased when compared to controls. A significant decreased food consumption was observed in females of the same dose group during lactation. Since this effect was not dose-related, it was regarded to be not treatment related.
HAEMATOLOGY
A significant decrease of 3% of mean corpuscular haemoglobin concentration in males of the 300 and 1000 mg/kg bw/day dose groups was observed after 42 days of treatment. Since this effect showed no clear dose-relation, it was regarded as non-adverse.
CLINICAL CHEMISTRY
A significant decrease of the glucose level (22%) in the 1000 mg/kg bw/day dose group males was observed. Additionally a decrease in total protein (4%) and calcium (5%) in the 300 mg/kg bw/day dose group males and in ALP (16-18%) in males of all dose groups was found. As these effects occured sporadically and showed no dose-relationship, they were regarded as non-adverse.
ORGAN WEIGHTS
In the 100 mg/kg bw/day dose group, a significant liver weight increase (12% (absolute weight), 5% (relative weight)) in males and a signficant decrease in kidney weights in females (8% (absolute weight), 3% (non-adervse)) was observed. As there was no dose relationship and no effects were observed at histopathology, they were regarded as non-adverse.
GROSS PATHOLOGY
In males of the 100 mg/kg bw/dose group, diminishment of thymus (1 animal), accessory spleen (1 animal) and liver changes (yellowish colouring (2 animals), pale spot (1 animal), accentuation of lobular pattern (1 animals)) were observed. In males of the 300 mg/kg bw/dose group, enlargment of thyroid (1 animal), pale lung (1 animal), diminishment of thymus (1 animal) and liver changes ((pale area (2 animals), pale spot (1 animal)) were observed. In males of the 1000 mg/kg bw/dose group, diminishment of thymus (1 animal), small and enlarged thymus (1 animal each), pale lung (1 animal) and yellowish colouring of the liver (2 animals) was observed.
Focal constriction of the spleen was observed in two high-dose group females and adrenal enlargement in one female animal of the 100 mg/kg bw/day dose group. Since the observed effects in male and female animals were found without any dose-relationship and only in few animals, they were regarded as not treatment related.
HISTOPATHOLOGY: NON-NEOPLASTIC
Mycardial degeneration, liver fatty change, changes in spleen and kidney were found to the same extent in few male animals of the highest dose group as compared to males of the control group. One male animal of the highest dose group showed slight fibrosis of the adrenal gland and another one very slight changes of the testes.
The only change differing from controls in females of the high dose group was a thalamus mineralisation in the brain found in one animal. Thus, the effects were regarded as not treatment related.
Effect levels
- Dose descriptor:
- NOAEL
- Remarks:
- (repeated dose toxicity)
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no substance-related findings were observed
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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