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EC number: 201-111-9 | CAS number: 78-38-6
- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diethyl ethylphosphonate
- EC Number:
- 201-111-9
- EC Name:
- Diethyl ethylphosphonate
- Cas Number:
- 78-38-6
- Molecular formula:
- C6H15O3P
- IUPAC Name:
- diethyl phosphonate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- At 8-12 weeks; female animals were non-pregnant and nulliparous
The animals were housed in plastic cages suspended on stainless steel racks in a room equipped with central air-conditioning. The room temperature was within the range of 22 ± 2°C; relative humidity was within the range of 55 ± 10 %. The light regimen was set to a 12-hour light / 12-hour dark cycle The sanitation was performed according to standard operation procedures.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Duration of treatment / exposure:
- The animals were dosed daily for 7 days a week.
- Frequency of treatment:
- Once per day.
Females were treated during:
- 14-day pre-mating,
- 14-day mating (maximum)
- 22-day gestation (approximately)
- 13-day lactation
Males were treated during:
- 14-day pre-mating,
- 14-day mating (maximum)
The animals designated for post-treatment observation (5 animals per sex in control and high groups, respectively) remained untreated for subsequent 14 days.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 25 mg/kg bw/day
- Remarks:
- Low
- Dose / conc.:
- 50 mg/kg bw/day
- Remarks:
- Mid
- Dose / conc.:
- 150 mg/kg bw/day
- Remarks:
- High
- Dose / conc.:
- 150 mg/kg bw/day
- Remarks:
- High satellite
- Control animals:
- yes, concurrent vehicle
Examinations
- Statistics:
- Individual data (five males and all pregnant females) of clinical chemistry, haematology, body
weight, relative weight of organs, and T4 levels obtained in the experiment were assessed applying
statistical software StatgraphicsTM Centurion. Kruskal-Wallis statistical procedure of multiple
comparison was adopted to test the null hypothesis that the medians among the dose groups
(control, low, mid, high) are the same. The p-value of 0.05 was considered as the level of statistical
significance. In the case of statistically significant outcome the Kruskal-Wallis was followed by
Mann-Whitney W test to determine which medians are different from which other. Basic
descriptive statistics (mean, SD) are reported as well.
Results of Tail flick test and Grip-strength test are presented as mean ± sd. Significance of the
difference between the results was determined using the ANOVA test. Difference between the
means of Low, Mid, High and Control group at the 0.05 significance level was considered
significant. The data were evaluated by statistical software StatgraphicsTM Centurion.
Reproduction/developmental and locomotor activity data were analysed using STATISTICA 7.0
(Statsoft, Inc. Tulsa, OK) software. The data are represented as mean ± S.E.M (and were analysed
by one-way analyses of variance (ANOVA) followed by Dunnet’s post-hoc test for a multiple
comparison procedure to compare each of a number of treatments with a single control. The p<0.05
value was considered statistically significant.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Animals lived through the observation period without significant visible clinical signs. Daily clinical examination only tremor in one female (ID 99) of High dose was registered. No other signs were observed.
- Mortality:
- no mortality observed
- Description (incidence):
- The incidence of mortality in the animals of the High dose could be caused by the test item treatment. All other males and females at all dosage levels survived to the scheduled necropsy.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The body weight of males of all dose groups was mildly increasing during the study. No significant differences between control and dose groups were observed. The body weight of High dose satellite males was similar in comparison with recovery control males during the whole study.
The body weight of females of all dose groups was mildly increasing during the study. No significant differences between control and dose groups were observed. The body weight of recovery High dose females was similar in comparison with recovery control females during the whole study. - Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food consumption of males of all dose groups was similar to the control males during the whole study. Food consumption of recovery treated males was similar in comparison with control group during the whole application and recovery period.
Food consumption of treated females was similar in comparison with control group during the whole application period. Food consumption of recovery treated females was similar in comparison with recovery control females for the whole study. - Organ weight findings including organ / body weight ratios:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- In summary none of used doses significantly influenced length of pregnancy, number of implants, survival of pups, anogenital distance, or other variables.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 50 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 150 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- clinical signs
Overall reproductive toxicity
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 150 mg/kg bw/day (nominal)
- Treatment related:
- no
Applicant's summary and conclusion
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