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EC number: 421-920-2 | CAS number: 154862-43-8
- 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
- Study period:
- 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 421-920-2
- EC Name:
- -
- Cas Number:
- 154862-43-8
- Molecular formula:
- C53-H58-O6-P2
- IUPAC Name:
- 3,9-bis[2,4-bis(2-phenylpropan-2-yl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane
Constituent 1
- Specific details on test material used for the study:
- TEST ITEM NAME: Doverphos S-9228PC
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Dover Chemical Corporation, Lot No. 46D030816
- Expiration date of the lot/batch: March 08, 2017
- Purity: 99.3%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In original container in a dry/cool, well ventilated place.
- Solubility and stability of the test substance in the solvent/vehicle: stable in vehicle for 4 hours.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 11 to 13 wks
- Housing: individually, except during the mating period. During the mating period, the rats were housed in groups of 2 rats/cage (one male plus one female). Confirmed mated female rats were caged individually, and nesting material was provided from 14th day of gestation. During the study, the rats were housed in solid floor polypropylene rat cages (size: 41 x 28.2 x 18 cm). Each cage was fitted with a stainless steel top grill having provision for keeping a polypropylene water bottle with stainless steel drinking nozzle. The bottom of the cages were layered with clean sterilized rice (paddy) husk as the bedding.
- Diet (e.g. ad libitum): standard rodent pellet feed (Teklad Certified Global 16% Protein Rodent diet manufactured by Envigo, USA) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24 deg C
- Humidity (%): 64 - 67%
- Air changes (per hr): 20-21
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test dose formulations were prepared every day prior to dosing and were used within 4 hours of preparation. The prepared formulation was kept on
a magnetic stirrer in order to maintain a homogeneous preparation. The dose volume was 10 mL/kg body weight. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentration and homogeneity of the test item in the dose formulation was analysed using a vali dated HPLC method once before initiation of treatment and twice during treatment period. Dose form ulations were found to be within the acceptance level of ± 15% of nominal concentration demonstrati ng that the prepared concentrations were as intended by the study plan and %CV was less than 10, suggesting that the prepared formulations were homogeneously mixed.
- Details on mating procedure:
- Each female was placed with a single male from the same dose level until copulation occurred or 2 weeks had elapsed. Each morning, the females were examined for the presence of sperm and the ‘day 0’ of pregnancy was recorded. Day 0 of pregnancy was defined as the day on which sperm was observed in the vaginal smears of rats.
- Duration of treatment / exposure:
- Dosing of both the sexes was initiated 2 weeks prior to mating and continued during the mating period. After mating, the male rats were further dosed up to and including the day before scheduled sacrifice (after approximately 80% of the females had delivered ). Females were further dosed during pregnancy and up to post-partum day 3.
- Frequency of treatment:
- once daily, seven days a week, at approximately the same time each day
- Duration of test:
- See Duration of treatment / exposure above
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 15 males and 15 females per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The dose levels were selected based on the results of 14-day dose range finding study (JRF Study N° 410-1-04-14642), in which no test item related effect was observed in high dose (i.e., 1000 mg/kg b. wt./day) on body weight, feed consumption and organ weight.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Animals were observed twice a day for mortality and morbidity
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: All animals were observed twice a day for visible clinical signs during the treatment period.
BODY WEIGHT: Yes
- Time schedule for examinations: Body weight of all the male animals were recorded on the first d ay of dosing and at weekly interval thereafter and at death. Body weight of all female animals was recorded on first day of dosing and at weekly interval during pre-mating and mating period. During gestation period, female animals were weighed on gestation days 0, 7, 14 and 20. During lactation p eriod, female animals were weighed within 24 hours of parturition (day 0 post-partum), post-partum day 4 (i.e., lactation day 4) and at death.
FOOD CONSUMPTION:
- Feed consumption of all male animals was measured weekly during pre-mating and post-mating p eriod. For female animals, during pre-mating period feed weights were recorded at weekly interval. During gestation period, feed weights were measured on days 0, 7, 14 and 20 and during lactation period, feed weights were measured on lactation days 0 and 4. Feed consumption was not measured during mating period.
GROSS PATHOLOGY
- All animals were subjected to full gross necropsy. - Ovaries and uterine content:
- During sacrifice, number of corpora lutea and implantation sites were recorded for each dam.
- Fetal examinations:
- Each litter was examined as soon as possible after delivery to establish the number of pups, sex of pups, stillbirths, runts and the presence of gross anomalies. Pups which were found dead in the study were weighed and subjected to post-mortem examination.
Individual pup body weight was recorded on lactation days 0 and 4.
All pups were subjected to gross pathological examination. - Statistics:
- Data such as body weight, body weight change, feed consumption, uterine data (number of imp lantation, number of corpora lutea, the mean number and percent of pre-implantation, post-implantat ion and post-natal loss), litter parameters (number and weight of male pups, female pups, total pup
s (male + female)), duration of gestation and pre-coital interval were analysed using Bartlett’s test
of homogeneity of variance. If the result was not significant then analysis of variance (ANOVA) was carried out and if the results was significant then t-test was carried out. If ANOVA was significant then Dunnett’s multiple comparison tests was carried out.
Data such as mortality rate, gestation index, parturition index, pups survival index, live birth index and fertility index were analyzed using Chi-Square test. - Indices:
- Reproductive indices
male fertility index, female fertility index, gestation index, parturition index and mating index, gestation period and pre-coital interval, pre-implantation loss, pre-natal (post-implantation) loss, post-natal loss.
Offspring viability indices
live pups index and live birth index, survival / mortality index
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Body weight and weight changes:
- no effects observed
- Gross pathological findings:
- no effects observed
Maternal developmental toxicity
- Details on maternal toxic effects:
- no effects were observed on duration of pregnancy, pre-implantation loss, parturition index, or live birth index.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: No effects observed at the limit dose of 1000 mg/kg/day
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 other: maternal dose in mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: No effects observed at the highest dose tested
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Daily oral gavage administration of the Doverphos S9228PC to male and female rats at dose levels of 250, 500 and 1000 mg/kg b. wt./day during pre-mating, mating, post-mating, gestation period and until post-partum day 3 did not produce test item-related adverse effects on reproduction and development. Thus, the No Observed Adverse Effect Level of Doverphos S9228PC was found to be 1000 mg/kg b. wt./day.
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