Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-337-2 | 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 October 1995 - October 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed under GLP conditions and according to a protocol equivalent or similar to OECD guideline 414.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
- Reference Type:
- publication
- Title:
- Developmental toxicity study of orally administered resorcinol bis-diphenylphosphate (RDP) in rabbits
- Author:
- Ryan, B.M., Henrich, R., Mallett, E., Freudenthal, R.I.
- Year:
- 2 000
- Bibliographic source:
- International Journal of Toxicology, 19: 257-264
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- treatment period according to old guideline (exposure GD 6-29 in stead of complete gestation period)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 3-[(diphenoxyphosphoryl)oxy]phenyl diphenyl phosphate
- EC Number:
- 701-337-2
- Cas Number:
- not available
- Molecular formula:
- C30H24O8P2
- IUPAC Name:
- 3-[(diphenoxyphosphoryl)oxy]phenyl diphenyl phosphate
- Details on test material:
- - Name of test material (as cited in study report): Fyrolflex RDP
- Physical state: Liquid
- Analytical purity: Confidential information
- Impurities (identity and concentrations): Confidential information
- Purity test date: Confidential information
- Storage condition of test material: At room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products (HRP), Inc., Denver, PA
- Age at study initiation: approx. 4.5 months (females)
- Weight at study initiation: 2.92-3.44 kg (females)
- Housing: under standard conditions
- Diet (e.g. ad libitum): Ad libitum, 50:50 mixture of high fiber and rabbit chow
- Water (e.g. ad libitum): Ad libitum, municipal water
- Acclimation period: two weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25
- Humidity (%): 30-69
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Doses of the test substance at 50, 200 and 1000 mg/kg bw/day were prepared in a corn oil vehicle at a constant dosing volume of 1.5 ml/kg bw. Individual doses were prepared daily, mixing the contents using a stopcock connector.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Not necessary, accepted vehicle
- Amount of vehicle (if gavage): 1.5 ml/kg
- Lot/batch no. (if required): 114H0275 - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:1
- Length of cohabitation: not indicated
- Further matings after two unsuccessful attempts: no
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of gestation
- Any other deviations from standard protocol: - Duration of treatment / exposure:
- 23 days (gestation days 6 through 29)
- Frequency of treatment:
- Once daily
- Duration of test:
- 29 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
50, 200, 1000 mg Fyrolflex RDP/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
31.5, 125.8, 629 mg RDP/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 27
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not relevant
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice (weekdays) or once (weekends) daily
- Cage side observations: mortality
DETAILED CLINICAL OBSERVATIONS: Yes, clinical examinations
- Time schedule: Prior to randomization and study initiation
BODY WEIGHT: Yes
- Time schedule for examinations: at randomization, every two days during gestation, at study termination
FOOD CONSUMPTION:
- Food consumption recorded: Yes, but not corrected for spillage
- Time schedule: Day 0-29 (every 2 days) and at termination
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 29 (followed by gross necropsy)
- Organs examined: Liver, spleen, kidneys (histopathology) - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: Yes: one-third per litter - Statistics:
- - Mean and standard deviation (all parameters)
- Multivariate analysis of variance
- One-way ANOVA
- Post-hoc comparisons: Dunnett's test (in presence of significant main effects)
- Chi-square and Fischer Exact test (malformation data) - Indices:
- Not relevant
- Historical control data:
- Historical control values for anomalies in litter as published by the Middle Atlantic Reproduction and Teratology Association/Midwest Teratology Association (MARTA/MTA) were used.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
- No mortality related to treatment
- No dose-related clinical signs observed in any of the substance-treated groups
- No significant differences detected in body weight, uterus weight, corrected body weight or corrected body weight gain
- No biologically significant effect on food consumption
- No significant effects observed on mean liver, kidney and spleen weight
- No gross pathological abnormalities noted
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: No maternal toxicity up to the highest dose tested
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
- No statistically significant difference in number of live or total implants, resorptions, corpora lutea, or percent implantation loss
- No significant difference found in mean fetal weight
- No gross external malformations observed in the pups
- No dose related increase in incidence nor any clear pattern of visceral anomalies was noted. The fetal incidence is similar to or below the observed incidence for these anomalies as published by MARTA/MTA
- The incidence of cephalic anomalies was greatest in the high dose group, but is similar or well below the observed incidence for these anomalies as published by MARTA/MTA
- No skeletal anomalies were considered related to treatment. No skeletal anomalies were observed in the high dose group. The fetal incidence is similar to or below the observed incidence for these anomalies as published by MARTA/MTA
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effects were not observed up to the highest dose tested.
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
RESULTS OF TEST | DOSING GROUPS | |||
Control (vehicle) | Low (50 mg/kg bw/day) | Medium (200 mg/kg bw/day) | High (1000 mg/kg bw/day) | |
MATERNAL TOXIC EFFECTS BY DOSE LEVEL | ||||
Number of animals | 27 | 27 | 27 | 27 |
Mortality and day of death | 0 | 0 | 0 | 0 |
Body weight | x | x | x | Day 16-18: Significant increase in body weight gain |
Food consumption | x | x | x | Day 20: Significant increase in food consumption |
Clinical signs | x | x | x | x |
Number pregnant per dose level | 26 | 27 | 25 | 26 |
Number aborting | 0 | 0 | 0 | 0 |
Number of corpora lutea | 238 | 231 | 241 | 254 |
Number of implantations | 234 | 227 | 226 | 236 |
Number of resorptions early/late | 14/3 | 5/7 | 9/2 | 7/10 |
Pre-implantation loss | 4 | 4 | 15 | 18 |
Post-implantation loss | 17 | 12 | 11 | 17 |
Duration of Pregnancy | x | 2 animals: Premature delivery | 1 animal: Parturition on GD 29 | x |
Number of litters | 25 | 25 | 25 | 26 |
Gross pathology incidence and severity | 1 animal: mass on the left Fallopian tube, 1 animal: non-viable litter observed | x | x | x |
Organ weight changes (liver, kidney, spleen) | x | x | x | x |
FETAL DATA | ||||
Litter size (mean +/- SD) | 8.35 +/- 2.23 | 8.60 +/- 1.91 | 8.60 +/- 1.85 | 8.42 +/- 1.70 |
Number viable | 217 | 215 | 215 | 219 |
Litter weights | x | x | x | x |
Postnatal survival | x | x | x | Higher incidence of deaths in one litter |
Sex ratio (M/F) | 1:1 | 0.9:1 | 0.9:1 | 1.3:1 |
Grossly external abnormalities | 1 pup: abnormal hindlimb | x | x | x |
Visceral abnormalities | 1 pup: short/absent innominate, 1 pup: abnormal branching of the subclavian | 1 pup: common truncus, 1 pup: short/absent innominate, 2 pup of 1 litter: abnormal branching of the subclavian | x | 1 pup: short/absent innominate |
Skeletal abnormalities | 1 pup: fused ribs | 1 fetus: fused sternebrae, 2 pups: fused or forked ribs | 3 fetuses: fused sternebrae, 1 pup: unilateral absence of lumbar vertebral arch | x |
Cephalic abnormalities | x | 1 pup: slight hypoplasia of diencephalon | 1 pup: unilateral dilatation of ventricle | 3 pups of 2 litters: unilateral dilatation of ventricle, slight hypoplasia of diencephalon or ectopic lens and convoluted retina |
x = no effects (as compared to control group) |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, exposure to Fyrolflex RDP by oral gavage up to 1000 mg/kg bw/day was found not to result in maternal and developmental toxicity in rabbits. Therefore, a NOAEL of 1000 mg/kg bw/day was established. As a result, the substance does not need to be classified as toxic to reproduction based on the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.
- Executive summary:
Pregnant rabbits were exposed to Fyrolflex RDP by oral gavage from gestation day 6 through 29 in a concentration of 0, 50, 200 and 1000 mg/kg bw/day. Throughout the gestation period the dams were observed for clinical signs and body weight, food consumption was recorded. On day 29 of gestation the dams were sacrificed and post-mortem the liver, spleen and kidneys were weighed and examined. Uteri and ovaria were examined: gravid uterus weight and number of corpora lutea, implantations and resorptions was recorded. Litter was examined for gross external, visceral, cephalic and skeletal anomalies.
No clinical signs of maternal toxicity were evident during the study or were apparent from gross necropsy observations. Mean body weights, body weight gains, food consumption, uterus weights and organ weights showed no test substance relaeted effects.
No significant differences in fetal (litter) body weights were observed between the test substance-treated groups and the vehicle control. Also, no significant increases in fetal deaths, resorptions, or malformations were observed between the test substance-treated groups and the control. The visceral, cephalic and skeletal malformations observed were low in incidence, sporadic in nature, and were not considered test substanc-related because no clear pattern or relationship between the affected structure and dose group could be established. All anomalies were similar to or below the historical control values for anomalies in litter as published by the Middle Atlantic Reproduction and Teratology Association/Midwest Teratology Association (MARTA/MTA).
Under the conditions of this study, exposure to Fyrolflex RDP by oral gavage up to 1000 mg/kg bw/day was found not to result in maternal and developmental toxicity in rats. Therefore, a NOAEL of 1000 mg/kg bw/day was established. As a result, the substance does not need to be classified as toxic to reproduction based on the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.