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EC number: 915-316-2 | 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:
- two-generation reproductive toxicity
- Remarks:
- based on generations indicated in Effect levels (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- February 1976 to May 1977
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Test procedure in accordance with scientific standard methods, before GLP guidelines). No information on test substance purity. Very limited information on experimental procedures. Limited endpoints examined and no statistics reported. Only a single, low, dose was used.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 1 male and 5 female Wistar rats were mated after 6 months of test substance administration in diet at dose level of 100 ppm (approximately 5 mg/kg bw/day). Of the F1 animals, 5 males and 5 females were administered test substance through diet until the end of the study. 1 treated male and 5 treated females from the F1 were mated in order to obtain a second generation from which 5 males and 5 females were also treated with test substance through diet until the end of the study.
All the new born animals were subjected to a detailed macroscopic examination and 10 F1 and 10 F2 offspring were sacrificed for autopsy. - GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of 1-phenyloctadecane-1,3-dione and phenylicosane-1,3-dione
- EC Number:
- 915-316-2
- Molecular formula:
- C50H80O4
- IUPAC Name:
- Reaction mass of 1-phenyloctadecane-1,3-dione and phenylicosane-1,3-dione
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: institut de Médecine du Travail
- Age at study initiation:
- Weight at study initiation:
- Fasting period before study:
- Housing: metal cages
- Diet (type + e.g. ad libitum): no data, ad libitum
- Water (type + e.g. ad libitum): no data
- Acclimation period: rats used were bred in the institute where the study was conducted
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on exposure:
- - Preparation of dosing solutions: no data
- Diet preparation:no data
- Vehicle: no data - Details on mating procedure:
- - M/F ratio per cage:1 male/5 females
- Length of cohabitation: no data
- Proof of pregnancy: no data
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility: no data
- Further matings after two unsuccessful attempts: no data
- After successful mating each pregnant female was caged (how): no data
- Any other deviations from standard protocol:no data - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 6 months for males and females
- Frequency of treatment:
- no data , but assumed daily
- Details on study schedule:
- - F1 parental animals not mated until [...] weeks after selected from the F1 litters: no data
- Selection of parents from F1 generation when pups were [...] days of age: no data
- Age at mating of the mated animals in the study: no data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- 1 male, 5 females in each generation
- Control animals:
- yes, historical
- Positive control:
- no
Examinations
- Parental animals: Observations and examinations:
- * Cage side observations: No data
* Detailed clinical observations: No data
* Body weight: No data
* 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: YNo data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
* Water consumption and compound intake (if drinking water study): No data
- Time schedule for examinations: no data - Oestrous cyclicity (parental animals):
- not examined
- Sperm parameters (parental animals):
- not examined
- Litter observations:
- - Standardisation of litters: no data
- Parameters examined
The following parameters were examined in [F1 / F2] offspring: presence of gross anomalies
- Gross examination of dead pups: no data - Postmortem examinations (parental animals):
- - Sacrifice:
* Male animals: All surviving animals
* Maternal animals: All surviving animals
- Gross necropsy: Gross necropsy consisted of external and internal examinations including cranio-cerebral, digestive, thoraco-visceral abdominal or genital organs.
- Histopathology / organ weights: no data - Postmortem examinations (offspring):
- - Sacrifice:
* The F1 offspring not selected as parental animals and all F2 offspring were sacrificed at [unknown] days of age.
* These animals were subjected to postmortem macroscopic examinations as follows: all the new born animals
- Gross necropsy: Gross necropsy consisted of external and internal examinations without reported details.
- Histopathology / organ weights: no data reported on organ weight. Lungs, liver, spleen and kidneys were analysed by histopathological examination only for 10 animals from the F1 and 10 of the F2 - Statistics:
- no data
- Reproductive indices:
- no data
- Offspring viability indices:
- no data
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 100 ppm (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: No macroscopic or microscopic abnormalities reported
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 100 ppm (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: No macroscopic or microscopic abnormalities reported
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
The mating of 1 treated male and 5 treated female P generation rats gave rise to a first generation (F1) of 38 rats (13 males and 25 females).
The
mating of 1 treated
male and 5 treated females from the F1 generation gave rise to 44 F2 offspring
(20 males and 24 females).
All the new born animals were subjected to a detailed macroscopic
examination in which no abnormalities were found.
10 pups from each of the F1 and F2 generation were autopsied, revealing no microscopic abnormalities.
Applicant's summary and conclusion
- Conclusions:
- No effects on parental animals or offspring. NOAEL (parental & developmental) = 100 ppm (corresponding to approximately 5 mg/kg b.w./day). However, this single test concentration was too low to draw a definitive conclusion on the potential of the test substance for effects on reproduction at high concentrations in the diet.
- Executive summary:
In a satellite 2-generation reproduction study combined with a chronic/carcinogenic study conducted before guidelines (1977), one male and five female Wistar rats were mated after 6 months of SAP RP test substance (corresponding to stearoylbenzoylmethane) administration through diet at dose level of 100 ppm (corresponding to approximately 5 mg/kg bw/day). The pairings gave rise to a first generation (F1) of 38 rats (13 males and 25 females). Of the F1 animals, five males and females were administered SAP RP test substance through diet until the end of the study. One treated male and five treated females from the F1 were mated in order to obtain a second generation. This generation was composed of 44 rats (20 males and 24 females) from which five males and females were also treated with SAP RP test substance through diet until the end of the study.
All the new born animals were subjected to a detailed macroscopic examination and 10 animals of the F1 and 10 rats of the F2 were sacrificed for autopsy. No abnormalities (cranio-cerebral, digestive, thoraco-visceral abdominal or genital) were observed. The histological examination (lungs, liver, spleen and kidneys) of these animals showed no abnormalities.
Under these test conditions, SAP RP showed no adverse effects on parental animals or histological or macroscopic abnormalities in the new born animals from exposed parents: the test substance SAP RP is not considered as toxic to reproduction or teratogenic.
This reproduction study in the rat is acceptable as part of a weight of evidence approach because little information on protocol was reported, the endpoints examined were limited and only a single, low, dose level was tested. The study does not satisfy the guideline requirement for a reproduction study OECD 416 in rat.
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