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EC number: 305-673-7 | CAS number: 94944-95-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Remarks:
- conducted under the Cuban Good Laboratory Practices (GLP) guidelines
- Limit test:
- no
Test material
- Reference substance name:
- Octacosanoic acid
- EC Number:
- 208-041-8
- EC Name:
- Octacosanoic acid
- Cas Number:
- 506-48-9
- Molecular formula:
- C28H56O2
- IUPAC Name:
- octacosanoic acid
- Details on test material:
- D-003 is a mixture of long-chain fatty acids isolated and purified from sugar cane wax whose major component is 1-octacosanoic acid, followed by 1-triacontanoic, 1-dotriacontanoic, and 1-tetratriacontanoic acids. Other acids are present at lower concentrations
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CENPALAB (La Habana, Cuba)
- Age at study initiation: no data
- Weight at study initiation: 2.5-3.5 kg
- Housing: individually
- Diet: CENPALAB-certified Rabbit Lab chow ad libitum
- Water: tap water ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 50%
- Air changes (per hr): not indicate
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: suspension of water with 1% Acacia Gum
- Remarks:
- maximum dosing volume 5 mL/kg bw
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dosing suspensions were prepared fresh weekly and refrigerated after corroborating their stability in such
conditions. - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1
- Length of cohabitation: no data
- Proof of mating: indicated as copulation observed - Duration of treatment / exposure:
- days 6 through 18 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- until day 29 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 27 mated females per dose group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: 1000 mg/kg bw is considered an acceptable upper limit dose by ICH/OECD guidelines.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes daily
BODY WEIGHT: Yes on regular basis and at least on day 0, 6, 18 and 29
FOOD CONSUMPTION Yes, on regular basis
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 29
- Organs examined: not specified
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- All fetuses: body weight, sex
- External examinations: Yes: all per litter
- Soft tissue examinations: Yes half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: half per litter(examined by freehand coronal sectioning) - Statistics:
- Maternal initial body weight, maternal weight gain, fetal body weights were analyzed using a parametric analysis of variance followed by Tukey's multiple comparison test. Data on numbers of corpora lutea, implantations, resorptions, dead and alive fetuses, sex ratio and litter size were analyzed by the Kruskal–Wallis (nonparametric) test followed by Mann–Whitney U-test to determine which treatment groups differed from the control. The incidence of fetuses and litters with malformations was compared to that of the control group by using Chi square and Fischer's exact probability test, respectively.
Trend analysis via ANOVA, Jonckheere's test and the Cochran–Armitage test. - Indices:
- no data
- Historical control data:
- NA
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- 1 female at 500 mg/kg bw and 1 female at 1000 mg/kg bw
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- see table
- 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:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- statement in the publication
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Number of abortions:
- effects observed, non-treatment-related
- Description (incidence and severity):
- in both treament groups and in controls 2 abortions/group were reported (see table)
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- Preimplantation loss ( [(Corpora lutea minus implant sites)/corpora lutea] x100): 24, 13 and 11 at 0, 500 and 1000 mg/kg bw
Postimplantation loss ([(Implant sites minus viable fetuses)/implant sites] x 100): 14, 23 and 22 at 0, 500 and 1000 mg/kg bw - Total litter losses by resorption:
- effects observed, non-treatment-related
- Description (incidence and severity):
- total resorptions : 2, 1 and 1 at 0, 500 and 1000 mg/kg bw
- Early or late resorptions:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Early 0.3 ± 0.6, 0.8 ± 1.5 and 0.5 ± 0.5 at 0, 500 and 1000 mg/kg bw
Late 0.05 ± 0.2, 0.05 ± 0.2 and 0.2 ± 0.5 at 0, 500 and 1000 mg/kg bw - Dead fetuses:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Dead fetuses 0.2 ± 1.1, 0 and 0.2 ± 0.7 at 0, 500 and 1000 mg/kg bw
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- effects observed, non-treatment-related
- Description (incidence and severity):
- pregnancy rate: 23/27, 21/27 and 21/27 at 0, 500 and 1000 mg/kg bw
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: absence of effects
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- fetal body weight (mean/litter) 35.0 ± 5.5, 36.8 ± 5.9 and 33.8 ± 8.7 g at 0, 500 and 1000 mg/kg bw
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- Live fetuses 4.3 ± 1.8, 4.2 ± 1.5 and 4.8 ± 2.2 at 0, 500 and 1000 mg/kg bw
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- Sex ratio (M/F) 44/46, 44/35 and 43/48 at 0, 500 and 1000 mg/kg bw
- Changes in litter size and weights:
- not examined
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Description (incidence and severity):
- see table
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- delayed ossification in controls and in both treatment groups (see table)
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- see table
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: absence of adverse effects
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The substance does not induce any developmental or teratogenic effects in rabbits.The NOAEL is 1000 mg/kg bw
- Executive summary:
Pregnant New Zealand rabbits were given D-003 as oral doses of 500 and 1000 mg/kg/day on days 6 through 18 of gestation without any evidence of embryotoxicity or teratogenicity. The no-observed-effect dose in these two experimental studies was 1000 mg/kg/day. After assessment of the potential of high doses of D-003 to act on developing embryo, no evidence supports the conclusion that D-003 is a developmental toxicant/teratogen.
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