Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-066-9 | CAS number: -
- 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:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
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
- IUPAC Name:
- docosanoic acid
- Test material form:
- solid: particulate/powder
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 Japan, Hino, Tokyo
- 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 ºC
- Humidity (%): 50-65 %
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Solutions prepared more frequently than once a week. Aliquots kept refrigerated in airtight conditions.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Insoluble in water
- Amount of vehicle (if gavage): 5 mL/kg bw
- Lot/batch no. (if required): V6H2050 - Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: up to two weeks
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy
- Further mating after two unsuccessful attempts: no
- After successful mating each pregnant female was caged (how): individually - Duration of treatment / exposure:
- Exposure duration:
Males, 42 days
Females, from 14 days prior to mating to day 3 of lactation - Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- vehicle
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 13 animals per sex and dose.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on preliminary result in a 14 day-repeated dose toxicity study, where no signs of toxicity were found
Examinations
- Parental animals: Observations and examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once a day
BODY WEIGHT: Yes
- Time schedule for examinations: once a week
FOOD CONSUMPTION:
- Time schedule for examinations: once a week
HAEMATOLOGY: Yes
- Time schedule for collection of blood: after 42 days, prior to sacrifice
- Anaesthetic used for blood collection: Yes (identity): pentobarbital sodium
- Animals fasted: 18 - 24 hours before sacrifice
- How many animals: all surviving animals
- Parameters checked: 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 concentration (MCHC), differentiation of leukocytes (band neutrophil, segmented neutrophil, eosinophil, basophil, monocyte, lymphocyte).
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: after 42 days, prior to sacrifice
- Animals fasted: 18 - 24 hours before sacrifice
- How many animals: all surviving animals
- Parameters checked: 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, γ-GTP. - Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
Clinical observations (once a day), body weight on day 0 and 4 of lactation.
DEVELOPMENTAL PARAMETERS:
Day 0 of lactation: number of pups born, delivery index, number of live pups, birth index, live birth index, sex ratio.
Day 4 of lactation: number of live pups, viability index, sex ratio. - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals, on the day after the administration period.
- Maternal animals: All surviving animals, 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.
GROSS NECROPSY
- Organs examined: Males: tyroid gland, thymus, lung, liver, spleen. Females: thymus, spleen, adreanl gland, kidney.
- Organs weights: Males: heart, liver, kidneys, thymus, testes, epididymides. Females: heart, liver, kideny and thymus.
HISTOPATHOLOGY / ORGAN WEIGHTS
- Organs examined: Males: brain, heart, liver, spleen, thymus, kidney, urinary bladder, testis, epididymis. Females: brain, heart, liver, thymus, kidney, urinary bladder, adrenal gland, ovary.
REPRODUCTION PERFORMANCE:
Number of mated pairs, number of copulated pairs, copulation index, number of pregnant females, fertility index, pairing days until copulation and frequency of vaginal estrus.
DEVELOPMENTAL PARAMETERS:
Number of pregnant females, number of pregnant females with live pups, gestation index, gestation length in days, number of corporea lutea, number of implantation sites, implantation index. - Postmortem examinations (offspring):
- GROSS NECROPSY
- Full macroscopic examinations on all of pups (external and visceral observation). - 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:
- Copulation index, fertility index, implantation index, gestation index.
- Offspring viability indices:
- Delivery index, birth index, live birth index, viability index, sex ratio.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No abnormalities in general condition were observed in any of the treated groups.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- No deaths were observed in any of the treated groups.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no changes related to the dosing of compound in body weight gain.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- There were no changes related to the dosing of compound in food consumption.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No adverse effects were found in hematological examinations.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No adverse effects were found in biochemical examinations.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- At autopsy following treatment for 42 days in males and on postpartum day 4 in females, no adverse effects were found in the histopathological examinations.
- Histopathological findings: neoplastic:
- not specified
- 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
- Description (incidence and severity):
- The compound showed no adverse effects on copulation or fertility.
No changes related to the dosing of compound were observed in gestation length, gestation index, delivery and lactation.
The compound did not demonstrate any adverse effects on the sex ratio of pups.
Effect levels (P0)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects observed at the highest dose
Target system / organ toxicity (P0)
- Key result
- 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
- Description (incidence and severity):
- The compound did not demonstrate any adverse effects on viability of pups.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The compound did not demonstrate any adverse effects on body weights of pups.
- 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:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No morphological abnormalities in pups were observed in any of the treated groups.
- Histopathological findings:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- The compound did not demonstrate any adverse effects on the sex ratio of pups.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Key result
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects observed at the highest dose.
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The NOEL of docosanoic acid for maternal and reproductive toxicity was 1000 mg/kg/day both in males and females.
- Executive summary:
A combined repeated dose and reproduction/developmental screening was performed on docosanoic acid according to OECD Guideline 422. 13 rats per sex and per dose were exposed to 0 (vehicle), 100, 300 and 1000 mg/kg bw/day, males for 42 days and females from 14 days prior to mating to day 3 of lactation. The compound showed no adverse effects on copulation or fertility. No changes related to the dosing of compound were observed in gestation length, gestation index, delivery and lactation. The compound did not demonstrate any adverse effects on the sex ratio, body weights or viability of pups. Also, no morphological abnormalities in pups were observed in any of the treated groups. Based on these results the NOEL for maternal and reproductive toxicity was determined to be 1000 mg/kg bw/day for both males and females.
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.