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EC number: 922-551-4 | CAS number: 1187440-66-9
- 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
- Study period:
- 15 April 2008 - 11 June 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2009
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- except during study days -1 to 16, and except for the absence of chemical analyses of dosage forms
- Limit test:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report): LCE07103 = Alkylpolyphosphate
- Substance type: UVCB
- Physical state: white powder or white flakes
- Purity: not indicated
- Impurities (identity and concentrations): not indicated
- Percentage of components: not indicated
- Purity test date: not indicated
- Lot/batch No.: T72851
- Expiration date of the lot/batch: 15 July 2008
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature, protected from sunlight
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: breeder
- Age at first treatment: approx. 10 weeks
- Weight at first treatment (mean): M=408 g, F=269 g
- Housing: individually, except during pairing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Relative humidity: 50 ± 20%
- Light/dark cycle: 12h/12h
- Ventilation: 12 cycles/hour of filtered, non-recycled air.
IN-LIFE DATES: beginning: 22 April 2008 / end: up to 11 June 2008
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
test item was ground, heated to 80°C, mixed with vehicle heated to 80°C, forming a suspension.
The test item dosage forms were prepared daily
VEHICLE
- Justification for use and choice of vehicle (if other than water): lipophilicity of the substance
- Concentration in vehicle: 10, 30 and 100 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg/day
- Lot/batch no. (if required): 057K6093
- Purity: not indicated - Details on mating procedure:
- - M/F ratio per cage: 1
- Length of cohabitation: until mating occurred
- Proof of pregnancy: vaginal plug, or sperm in vaginal smear - referred to as day 0 post-coitum
- In case of unsuccessful pairing: not detailed (pairing always succeeded)
- After successful mating each pregnant female was caged individually - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Absence of a practical method of analysis
- Duration of treatment / exposure:
- from 2 weeks before mating until the end of mating (males: total of 39 days) or day 5 pp (females: total of 43-51 days)
- Frequency of treatment:
- once daily
- Details on study schedule:
- - no F1 parents (only one generation mated).
- Age at mating of the mated animals in the study: 13-16 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg/day (m/f)
Basis:
other: nominal per gavage
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: no serious effects at up to 1000 mg/kg/day in a 14-day range-finding study, see 7.5.1
- Rationale for animal assignment: computerized stratification procedure (average body weight of each group is similar) - Positive control:
- none
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice a day
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule: day 1 and then weekly; and in F also days 0, 7, 14 and 20 post-coitum and days 1 and 5 post-partum
FOOD CONSUMPTION for each animal: Yes
- Time schedule: weekly (last 7-day consumption period)
FOOD EFFICIENCY: No
WATER CONSUMPTION: No - Oestrous cyclicity (parental animals):
- Yes : from a fresh vaginal lavage, each morning during the mating period, until the females were mated
- Sperm parameters (parental animals):
- No seminology examinations.
Testis and epididymis : weight (all males), microscopic exmaination (some rats: see table 1). - Litter observations:
- STANDARDISATION OF LITTERS: No
PARAMETERS EXAMINED:
The following parameters were examined in offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight on days 1 and 5, clinical signs - Postmortem examinations (parental animals):
- SACRIFICE
- All male survivors: after the end of the mating period
- All female survivors: on day 6 post-partum
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table 1 were prepared for microscopic examination and weighed, respectively. - Postmortem examinations (offspring):
- SACRIFICE
- Sacrifice on non-selected breeders/progeny: not applicable (only 1 generation of parents and of offspring)
- All pups sacrificed on day 5 post-partum
GROSS NECROPSY: Yes, on pups sacrificed and found dead
- external and internal examinations including the cervical, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGTHS: Not performed - Reproductive indices:
- Pre-implantation loss = 100 * (Number of corpora lutea - Number of implantation sites) / Number of corpora lutea
Post-implantation loss = 100 * (Number of implantation sites - Number of live fetuses) / Number of implantation sites
Mating index = 100 * Number of mated animals / Number of paired animals
Fertility index = 100 * Number of pregnant female partners / Number of mated pairs
Gestation index = 100 * Number of females with live born pups / Number of pregnant females
Live birth index = 100 * Number of live born pups / Number of delivered pups - Offspring viability indices:
- Viability index = 100 * Number of surviving pups on day 5 post-partum / Number of live born pups
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
There were no treatment-related deaths or sacrifices (deaths were due to gavage errors, cranial hematoma or non-pregnancy).
Hypersalivation and reflux at dosing were observed in all groups and may be related to the vehicle and/or the test item but are non-adverse
BODY WEIGHT GAIN:
All female dose-groups gained less body weight than controls during the premating period, but this did not continue during gestation and lactation and was therefore considered to be non-adverse.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- parental toxicity
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: NOAEL = highest tested dose. All female dose-groups gained less body weight than controls during the premating period, but this did not continue during gestation and lactation and was therefore considered to be non-adverse.
- Dose descriptor:
- NOEL
- Remarks:
- reproduction (mating and fertility)
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: NOEL = highest tested dose, without relevant effects.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOEL
- Remarks:
- offspring toxicity
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: NOEL = highest tested dose, without relevant effects.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Not required (no effects)
Applicant's summary and conclusion
- Conclusions:
- Under on the experimental conditions of this study, the No Observed Adverse Effect Level (NOAEL) for parental toxicity was considered to be 1000 mg/kg/day, the No Observed Effect Level (NOEL) for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day and the NOEL for toxic effects on progeny was 1000 mg/kg/day.
- Executive summary:
The test item, LCE07103, was administered daily by oral gavage to male and female Sprague-Dawley rats, for 2 weeks before mating, during mating, gestation and until day 5 post-partum, at dose-levels of 100, 300 or 1000 mg/kg/day.
There were no treatment-related deaths during the study and the only clinical signs observed were hypersalivation and reflux at dosing, which were considered to be related to treatment with the test item but are non-adverse. All female groups treated with LCE07103 gained less body weight during the premating period but this did not continue during gestation and lactation and was therefore considered to be non-adverse. There were no effects at any dose-level on food consumption. There were no differences from controls for pairing, mating and fertility parameters. Pups showed no effects of treatment on survival or body weight performance. No treatment-related macroscopic or microscopic findings were noted and there were no treatment-related organ weight changes.
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