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EC number: 219-641-4 | CAS number: 2489-05-6
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on generations indicated in Effect levels (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- OECD study but only extended summary available. Reliable as performed for the Japanese government by Hatano Research Institute, Food and Drug Safety Center (Japan). Additionally, the study was included in the official OECD SIDS document for docosanoic acid.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- OECD study but only extended summary available. Reliable as performed for the Japanese government by Hatano Research Institute, Food and Drug Safety Center (Japan). Additionally, the study was included in the official OECD SIDS document for docosanoic acid.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- /
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- Source: NOF CORPORATION, Lot No. 60805X, Purity: 85.9 %, Impurities: (C14-C 20) fatty acids (10.9 %) and C 24 fatty acid
(2.3%)
Kept at room temperature until use. - Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- /
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- /
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- /
- Duration of treatment / exposure:
- Males: 42 days;
Females: from 14 days prior to mating to day 3 of lactation - Frequency of treatment:
- daily
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 13 animals per sex per dose group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- · Vehicle: Corn oil
· Satellite groups and reasons they were added : none
· Clinical observations performed and frequency: Clinical signs were observed at least
once a day, body weights were basically determined once a week. Also, food consumption was measured nearly once a week except for mating period.
Hematologicalexaminations (only for males): Red blood cell count (RBC), white blood cell count (WBC), platlet count, hemoglobin (Hb), hematocrit
(Ht), mean corpuscular volume (MCV),mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin conc entration (MCHC),differentiation of leukocytes
Blood chemical examinations (only for males): total protein, albumin, A/G, blood urea nitrogen (BUN), creatinine, glucose, total cholesterol, total bilirubin, triglyceride, sodium (Na), potassium (K), chloride (Cl), calcium (Ca), inorganic phosphorus (IP), alkaline phosphatase (ALP), GPT, GOT, ?-GTP.
Organs examined at necropsy:organ weights: heart, liver, kidneys, thymus, testes, epididymides histopathological examinations: all animals in control and 1,000 mg/kg, and any organs which have histopathological changes at the higher doses: brain, heart, liver, spleen, thymus, kidney, adrenal, testis, epididymis, urinary bladder, ovary (only for females which were non pregnant or not copulated).
General remarks: This study was conducted to examine both repeated dose toxicity and reproductive/developmental toxicity as an OECD screening combined study. Therefore, haematological and blood chemical examinations, and urinalysis for females were not performed. Functional observation, estrous cycle length and pattern, and sperm examination were not performed because the test was conducted by the TG adopted in 1990. - Positive control:
- /
- Observations and examinations performed and frequency:
- Haematological, biochemical, gross findings, organ weights and histopathological examinations
- Sacrifice and pathology:
- /
- Other examinations:
- /
- Statistics:
- /
- 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:
- no effects observed
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Males: Decrease of MCHC at 300 and 1,000 mg/kg (p<0.01). However, this change in both groups was concluded as a casual one, because the degree of the change in both groups was very slight (the same 2.3 % decrease) and no other haematological changes were noted.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Males: Decrease of serum ALP in treated groups (p<0.05) and decrease of glucose at 1,000 mg/kg (p <0.05). However, these changes were considered to be toxicologically meaningless ones since they were slight and related histopathological findings were not observed.
- Urinalysis findings:
- not examined
- 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
- Description (incidence and severity):
- Males: No treatment-related abnormalities in heart, liver, spleen, kidneys, adrenals and epididymides. In testes, atrophy of seminiferous tube was recognized in two of thirteen at 1,000 mg/kg group, but they were considered not to be treatment related specific findings, because they were slight and sometimes observed in historical control data in the laboratory conducting this study. No abnormalities detected in brain, thymus and urinary bladder.
Female s: No treatment-related abnormalities in brain, liver, spleen, thymus, kidneys and adrenals. No abnormalities detected in heart, urinary bladder and ovaries. - Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Male: no deaths or abnormalities in clinical signs were observed in any of the treated groups. Also, there were no changes related to the dosing of compound in body weight gain and food consuption. No adverse effects werefound for haematological, biochemical, gross findings, organ weights and histopathological examinations.
Female: No deaths were observed in any of the treated groups. Also, there were no changes related to the dosing of compound in clinical signs, body weight gain and food consumption. No abnormal gross findings, changes of organ weights and histopathology were recognized at autopsy performed on postpartum day 4. - Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Critical effects observed:
- not specified
- Conclusions:
- No treatment related adverse effects were found in either dose group up to 1,000 mg/kg. NOAEL is estimated to be 1,000 mg/kg/day for this repeated dose toxicity study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
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)
- 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
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): Docosanoic acid
- Molecular formula (if other than submission substance): C22H44O2
- Molecular weight: 340,58g/mol
- Substance type:Not applicable
- Physical state:solid
- Analytical purity:85.9%
- Impurities (identity and concentrations):c14-C20 fatty acids: ca. 11%; C24 fatty acid: ca. 2%
Constituent 1
- Specific details on test material used for the study:
- Source: NOF CORPORATION, Lot No. 60805X, Purity: 85.9 %, Impurities: (C14-C 20) fatty acids (10.9 %) and C 24 fatty acid
(2.3%)
Kept at room temperature until use.
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Weight at study initiation: 312.1-363.7 g for males, 205.3 - 230.8 g for females
Number of animals per dose:13 per sex per dose
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- /
- Details on mating procedure:
- Male/female per cage; 1/1, length of cohabitation; at the most 14 days, until proof of pregnancy (formation of vaginal closing or sperm detection in vagina)
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- /
- Duration of treatment / exposure:
- Males, 42 days
Female, from 14 days prior to mating to day 3 of lactation - Frequency of treatment:
- Daily
- Details on study schedule:
- Age at study initiation was 8 week old for both sexes. Males were killed on the day after the administration period. Females were sacrificed on the day 4 of lactation. Females with no delivery were killed 4 days after the delivery expected date. Females with no copulation were sacrificed at the termination of mating period.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 13 per sex per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- · Vehicle: Corn oil
· Satellite groups and reasons they were added : none
· Clinical observations performed and frequency: Clinical signs were observed at least
once a day, body weights were basically determined once a week. Also, food consumption was measured nearly once a week except for mating period.
Hematologicalexaminations (only for males): Red blood cell count (RBC), white blood cell count (WBC), platlet count, hemoglobin (Hb), hematocrit
(Ht), mean corpuscular volume (MCV),mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin conc entration (MCHC),differentiation of leukocytes
Blood chemical examinations (only for males): total protein, albumin, A/G, blood urea nitrogen (BUN), creatinine, glucose, total cholesterol, total bilirubin, triglyceride, sodium (Na), potassium (K), chloride (Cl), calcium (Ca), inorganic phosphorus (IP), alkaline phosphatase (ALP), GPT, GOT, ?-GTP.
Organs examined at necropsy:organ weights: heart, liver, kidneys, thymus, testes, epididymides histopathological examinations: all animals in control and 1,000 mg/kg, and any organs which have histopathological changes at the higher doses: brain, heart, liver, spleen, thymus, kidney, adrenal, testis, epididymis, urinary bladder, ovary (only for females which were non pregnant or not copulated).
General remarks: This study was conducted to examine both repeated dose toxicity and reproductive/developmental toxicity as an OECD screening combined study. Therefore, haematological and blood chemical examinations, and urinalysis for females were not performed. Functional observation, estrous cycle length and pattern, and sperm examination were not performed because the test was conducted by the TG adopted in 1990. - Positive control:
- /
Examinations
- Parental animals: Observations and examinations:
- Body wt. (basically once a week), food consumption(basically
once a week), No. of pairs with successful copulation, copulation index (No. of pairs with successful copulation/No. of pairs mated x 100), pairing days until copulation, frequency of vaginal estrus, No. of pregnant females, fertility index = (No. of pregnant animals/No. of pairs with successful copulation x 100), No. of corpora lutea, No. of implantation sites, implantation index (No. of implantation sites/No. of corpora lutea x 100), No. of living pregnant females, No. of pregnant females with parturition, gestation length, No. of pregnant females with live pups on day 0, gestation index (No. of females with live pups/No. of living pregnant females x 100), No. of pregnant females with live pups on day 4, delivery index (No. of pups born/No. of implantation sites x 100), - Oestrous cyclicity (parental animals):
- /
- Sperm parameters (parental animals):
- /
- Litter observations:
- No. of pups alive on day 0 of lactation, live birth index (No. of live pups on day 0/No. of pups born x 100), sex ratio (Total No. of male pups/Total No. of female pups), No. of pups alive on day 4 of lactation, viability index (No. of live pups on day 4/No. of live pups on day 0 x 100), body wt. of live pups (on day 0 and 4).
- Postmortem examinations (parental animals):
- Parent: organ weight: heart, liver, kidneys, thymus, testes,
epididymidesHistopathological examinations: all animals in control and 1,000 mg/kg, and any organs which have histopathological changes at the higher doses: brain, heart, liver, spleen, thymus, kidney, adrenal, testis, epididymis, urinary bladder, ovary (only for females which were non pregnant or not copulated). - Postmortem examinations (offspring):
- Foetal: full macroscopic examinations on all of pups
- Statistics:
- Dunnett’s or Scheffe’s test for continuous data, Chi square test for copulated index and fertility index, and Mann-Whitney U
test or Fisher’s test for histopathological examination data. - Reproductive indices:
- /
- Offspring viability indices:
- /
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- 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:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: /
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- no effects observed
- Anogenital distance (AGD):
- not examined
- Nipple retention in male pups:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
- Other effects:
- no effects observed
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: /
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- There were no treatment related abnormalities. NOAELs for both maternal and foetal toxicity are 1,000 mg/kg/day.
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