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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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
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:
- EPA OPPTS 870.3800 (Reproduction and Fertility Effects)
- Deviations:
- yes
- Remarks:
- only exposure of the parental (P0) generation
- 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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CENPALAB (La Habana, Cuba)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: (P) 10-12 wks; (F1) postnatal 10-12 wks
- Weight at study initiation: (P) Males: 123 g; Females: 98 g; (F1) no data
- Housing: individually
- Diet: CENPALAB-certified Rat 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): no data
- 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 10 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.
- Details on mating procedure:
- - M/F ratio per cage: P0 2 females/ 1 male; F1 1 male/afemale
- Length of cohabitation: no data
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Female rats for 15 days prior to mating, through mating and gestation to day 21 of lactation and male rats for 4 weeks prior and during mating
- Frequency of treatment:
- daily
- Details on study schedule:
- - F1 parental animals not mated until 10-12 weeks after selected from the F1 litters.
- Selection of parents from F1 generation at weaning, when pups were 21 days of age.
- Age at mating of the mated animals in the study:10-12 weeks
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:
- 30 females and 15 males
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Only exposure of the P0 animals
Dose selection rationale: 1000 mg/kg bw is the acceptable upper limit dose by ICH/OECD guidelines.
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes daily
DETAILED CLINICAL OBSERVATIONS: no data
BODY WEIGHT: Yes regulary at least on day 0, 6, 13 and 20 of gestation and at day 1, 4, 7, 14 and 21 of lactation
FOOD CONSUMPTION: Yes, regulary
WATER CONSUMPTION: No - Oestrous cyclicity (parental animals):
- not investigated
- Sperm parameters (parental animals):
- not investigated
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: yes
- If yes, maximum of 4/sex/litter excess pups were killed and discarded.
PARAMETERS EXAMINED
The following parameters were examined in F1 / F2 offspring: post natal day 1 number, weight, external examination and sex
F1 offspring: survival, weight and locomotor activity on day 4, 7, 14 and 21 (for F1 animals selected for mating: body weight weekly)
F1 offspring: day 4 unfolding of the pinnae and righting in air on day 4; day 10 hair growth; day 12 eruption of the incisors; day 13 opening of the ear; day 14 visual placing and auditory startle; day 15 opening of the eyes ; day 17 pupilar, corneal and parpebral reflexes; day 21 activity measurements
such as squares entered, urination/defecation and standing on hindlegs; day 25 testicular descent; day 37 vaginal canalization
GROSS EXAMINATION OF DEAD PUPS: no data
ASSESSMENT OF DEVELOPMENTAL NEUROTOXICITY: not investigated
ASSESSMENT OF DEVELOPMENTAL IMMUNOTOXICITY: not investigated - Postmortem examinations (parental animals):
- not specified
- Postmortem examinations (offspring):
- not specified
- Statistics:
- Maternal initial body weight, maternal weight gain, fetal and pup body weights were analyzed using a parametric analysis of variance followed by Tukey's multiple comparison test. Data on dead and alive fetuses, sex ratio, litter size, survival through the weaning period and percentage of pups showing physical and reflex development were analyzed by the Kruskal–Wallis (nonparametric) test followed by Mann–Whitney U-test to determine which treatment groups differed from the control.
Trend analysis via ANOVA, Jonckheere's test and the Cochran–Armitage test. - Reproductive indices:
- not specified
- Offspring viability indices:
- not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- see attached 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):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not examined
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):
- see attached table
Pregnancy rate: 30/30. 28/30 and 29/30 at 0, 500 and 1000 mg/kg bw
Details on results (P0)
Effect levels (P0)
- 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 effects
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- see figure
- Food consumption and compound intake (if feeding study):
- not specified
- 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):
- not examined
- 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
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not specified
Effect levels (P1)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: no details except for body weight
Target system / organ toxicity (P1)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- see table (live pups and dead pups)
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- see table
- Food consumption and compound intake (if feeding study):
- not specified
- 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
- Description (incidence and severity):
- see table (no effects on testes and vaginal opening)
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- no effects on behavior and development (see table)
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- see table
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: no effects observed
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Results: F2 generation
General toxicity (F2)
- Mortality / viability:
- not specified
- Description (incidence and severity):
- no treatment related effects
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- body weight on day 1 did not show any treatment related effects
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- no treatment related effects
Details on results (F2)
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: absence of effects on mortality, body weight and external examinations
Target system / organ toxicity (F2)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No effects on reproductive performance in the exposed parental generation were observed at 1000 mg/kg bw.
No effects on development and reproductive performance of the F1 generation were observed at 1000 mg/kg bw. - Executive summary:
D-003 is a mixture of long-chain fatty acids isolated and purified from sugar cane wax with cholesterol-lowering properties. D003 given orally (500 and 1000 mg/kg/day) to female rats for 15 days prior to mating, through mating and gestation to day 21 of lactation and male rats for 4 weeks prior and during mating did not induce toxic effects on reproduction. There were no significant reductions in the number of animals that conceived, in the numbers of pups born to those that did conceive, in the numbers of pups that survived until weaning, and in their body weights at weaning. No treatment related effects in offspring were observed related to growth, physical and behavioral development, spontaneous activity and reproductive performance.
The NOAEL is 1000 mg/kg bw.
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