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EC number: 203-931-2 | CAS number: 112-05-0
- 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:
- three-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- Not the recommended number of animals. histopathology only on selected organs. No information on GLP status, limited investigation depth
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Deviations:
- yes
- Remarks:
- 3 generations; lower animal numbers; histopathology only on selected organs; No information on GLP status
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- cuphea oil
- IUPAC Name:
- cuphea oil
- Reference substance name:
- Cuphea oil
- IUPAC Name:
- Cuphea oil
- Details on test material:
- - Name of test material (as cited in study report): cuphea oil
- Molecular formula (if other than submission substance): triglyceride
- Fatty acid composition:
octanoate 4.8%
decanoate 75.9%
dodecanoate 2.5%
myristate 2.2%
palmitate 3.4%
stearate 0.7%
oleate 3.3%
linoleate 5.5%h
- Composition of test material, percentage of components: see above; analysed using gas chromatography
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- other: two strains were tested: CBA/2 and C57B1/6
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SASCO (Omaha, NE)
- Age at study initiation: (P) 8-10 wks
- Housing:
P: two females and one male together; females singly when vaginal plug was observed
F1, F2: weaned at 4 weeks, then housed together until sexual maturation, mating two females: one male. Females tehn hosued singly.
Males of each generation housed singly an dfed for 13 weeks; some males were fed for 5-12 months
- Diet: ad libitum
Feeding: Cuphea oil was limited, schedule was therefore as follows:
Strain 57B1/6:
F1: 10 months
F2: 8 months
F3: 11-12 months
Strain CBA/2:
F1: 11-12 months
F2: 9-11 months
F3: 6-8 months
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: basal diet
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): monthly
- Mixing appropriate amounts with (Type of food): basal diet with reduced beef tallow 886 g/kg instead of 172g/kg
- Storage temperature of food: 4°C - Details on mating procedure:
- - M/F ratio per cage: 1:2
- Length of cohabitation: until vaginary plug was noted
- Proof of pregnancy: vaginal plug
- After successful mating each pregnant female was caged: singly - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- GC determination of fatty acids in Cuphea oil
- Duration of treatment / exposure:
- Feeding: Cuphea oil was limited, schedule was therefore as foollows:
Strain 57B1/6:
F1: 10 months
F2: 8 months
F3: 11-12 months
Strain CBA/2:
F1: 11-12 months
F2: 9-11 months
F3: 6-8 months - Frequency of treatment:
- 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
8.6%
Basis:
nominal in diet
- No. of animals per sex per dose:
- Strain 57B1/6: F1: 16; F2: 16; F3: 13. Controls 15-17/generation
Strain CBA/2: F1: 25; F2: 11; F3: 5. Controls 5-29/generation - Control animals:
- yes
- Positive control:
- no
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations:
Animals fed for 13 weeks: weeks 4, 8, and 13
Animals fed for 5-12 months: : weeks 4, 13. 26, 39, and 45
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No. Total food intake in grams is given.
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No.
OTHER: - Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- No data
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: no data
PARAMETERS EXAMINED
The following parameters were examined in [F1 / F2 / F3] offspring:
number of live births, postnatal mortality, presence of gross anomalies, weight gain
GROSS EXAMINATION OF DEAD PUPS:
no - Postmortem examinations (parental animals):
- no data
- Postmortem examinations (offspring):
- no data
- Statistics:
- no data
- Reproductive indices:
- pregnancy index, pubs born/female
- Offspring viability indices:
- pubs at weaning/pups born
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- no consistent variation, but cuphea-fed mice had slightly lower body weights and lower feed intake
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- no consistent variations, but cuphea-fed mice had slightly lower body weights and lower feed intake
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Liver: excessive lipid accumulation (liver of most mice).
Kidneys: fat vacuoles in proximal cortical tubules of all mice; spleen in some mice enlarged - Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- Test substance intake: no consistent variations, but cuphea-fed mice had slightly lower body weights and lower feed intake
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 8.6 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- CBA/2 mice produced fewer offspring than females fed the basal diet.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- no effect in C57B1/6, in contrast to strain CBA/2 (strain-specific effect). Viability of pups from F1 and F2 parents reduced compared to those from F0 pups, but independent of the diet
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 10% reduced body weights in Cuphea fed C57B1/6 pups after 8 and 13 weeks. Reduced body weights in Cuphea fed CBA/2 pups after 13 weeks
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- 18% reduced food intake in cuphea fed C57B1/6 mice after week 8. Reduced food intake in cuphea fed CBA/2 pups after 8 and 13 weeks.
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- no effects observed
- Anogenital distance (AGD):
- not specified
- Nipple retention in male pups:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- comparable between grouops; where statistically significant changes were noted, Cuphea-fed mcie had lower body and liver weights
- Gross pathological findings:
- not specified
- Histopathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Liver: excessive lipid accumulation (liver of most mice); Kidneys: fat vacuoles in proxicmal cortical tubules of all mice; spleen in some mice enlarged
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 8.6 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results: F2 generation
General toxicity (F2)
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- In C57B1/6 mice, body weights in Cuphea fed pups were decreased by 20% at four weeks of age.
Reduced body weights in Cuphea fed CBA/2 pups after 8 weeks. - Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced food intake in Cuphea fed CBA/2 pups after 8 weeks
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Effect levels (F2)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- ca. 8.6 other: %
- Sex:
- male/female
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Comments to histopathology in F0, F1, and F3 animals of both tested strains:
Liver: lipid accumulation due to fat and cholesterol content of the diets. No differences between diets and generations in fatty liver development. The two strains showed marked differences, possibly because of differences in hepatic fat metabolism.
Renal vacuolar changes: likely caused by the high total lipid content of the fee No differences between diets or generations (table 7).
Preputial glands: strain-specific differences, no effect of treatment.
Lungs:. Changes noted, but not related to treatment or strain.
Applicant's summary and conclusion
- Conclusions:
- Feeding Cuphea oil to mice (two strains, 3 generations each) did not affect reproduction and had no adverse effect on parental animals. Cuphea oil appears to be nontoxic, but was of no particular health benefit. The NOAEL according to this study is > 8.6% cuphea oil in feed.
- Executive summary:
In this 3 generation feeding study two strains of mice (CBA/2 and C57B1/6) were fed a diet of 8.6% cuphea oil. Male and female mice were used. Controls were fed a basal diet with 17.2% beef tallow and 3.5% corn oil; in the diet for treated mice. In the treated mice, 8.6% Cuphea oil replaced 50% of the beef tallow, i.e. the diets were essentially isocaloric. The triglycerides of the Cuphea oil contained 75% decanoic acid, 4.8% octanoic acid, and small proportions of some long chain fatty acids.
Feeding Cuphea oil to mice (two strains, 3 generations each) did not affect reproduction and had no adverse effect on parental animals. Failureof mothers to succesfully nurture pups to weanling age (four weeks) was the only reproductive problem noted and affected the F1 and F2 mice of both diets, thus this is not related to cuphea oil. The F0 mice were exposed to a different diet and environment than were the F1 and F2 moce before breeding, but it is not clear how these differences might have led to the impairment of survival of pups in the later generations.
Animals were treated up to 12 months. Thus, Cuphea oil appears to be nontoxic, but was of no particular health benefit.
The study is not comparable with current test guidelines. However, basic scientific principles are met. According to this study, the NOAEL is 8.6% cuphea oil in both strains of mice.
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