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Diss Factsheets
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EC number: - | 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 26, 2017 - January 10, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 12-Nousan-8147
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of 1-hydroxypropan-2-yl diethylphosphinate and 2-hydroxypropyl diethylphosphinate
- Cas Number:
- 2230512-72-6
- Molecular formula:
- C7H17O3P
- IUPAC Name:
- Reaction mass of 1-hydroxypropan-2-yl diethylphosphinate and 2-hydroxypropyl diethylphosphinate
- Test material form:
- liquid
- Details on test material:
- R&D level
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Housing: The animals were singly housed in suspended stainless steel caging, which
conforms to the size recommendations in the most recent Guide for the Care and Use
of Laboratory Animals (Natl. Res. Council, 2011). Enrichment (e.g., toy) was placed
in each cage. Litter paper was placed beneath the cage and was changed at least
three times per week.
Animal Room Temperature and Relative Humidity Ranges: 20-23°C and 31-56%,
respectively.
Animal Room Air ChangeslHour: 12. Airflow measurements are evaluated regularly
and the records are kept on file at Product Safety Labs.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 19 or 20 days
Food: Envigo Teklad Global 16% Protein Rodent Diet® #2016. The diet was
available ad libitum.
Water: Filtered tap water was supplied ad libitum.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Two thousand milligrams of the test substance per kilogram of body weight was applied evenly
over a dose area of approximately 2 inches x 3 inches (approximately 10% of the body surface)
and covered with a 2-inch x 3-inch, 4-ply gauze pad. The gauze pad and entire trunk of each
animal were then wrapped with 3-inch Durapore tape to avoid dislocation of the pad and to
minimize loss of the test substance. The rats were then returned to their designated cages. The day
of application was considered Day 0 ofthe study.
After 24 hours of exposure to the test substance, the pads were removed and the test sites were
gently cleansed with a 3% soap solution followed by tap water and a clean paper towel to remove
any residual test substance. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg /kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- Two thousand milligrams of the test substance per kilogram of body weight was applied to the
skin of ten healthy rats for 24 hours. The animals were observed for mortality, signs of gross
toxicity, and behavioral changes at least once daily for 14 days. Body weights were recorded
prior to application (initial) and again on Days 7 and 14 (terminal). Necropsies were performed
on all animals at terminal sacrifice. - Statistics:
- Statistical analysis was limited to the calculation of the mean density value for dosing.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No
- Clinical signs:
- other: All animals survived test substance administration and gained body weight during the study. Apart from one animal exhibiting erythema on Day I, there were no other adverse clinical findings recorded for any animals over the course of the study. No gross a
- Gross pathology:
- No gross abnormalities were
noted for any of the animals when necropsied at the conclusion of the l4-day observation period See attached table 3 - Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- other: Not subject to classification under GHS
- Conclusions:
- Under the conditions of this study, the single dose acute dermal LD50 ofE17-194T is greater than
2000 mg/kg of body weight in male and female rats. - Executive summary:
SUMMARY
An acute dermal toxicity test was conducted with rats to determine the potential for
E17-194T to produce toxicity from a single topical application. Under the conditions of this
study, the single dose acute dermal LDso of the test substance is greater than 2000 mg/kg of body
weight in male and female rats.
Two thousand milligrams of the test substance per kilogram of body weight was applied to the
skin of ten healthy rats for 24 hours. The animals were observed for mortality, signs of gross
toxicity, and behavioral changes at least once daily for 14 days. Body weights were recorded
prior to application (initial) and again on Days 7 and 14 (terminal). Necropsies were performed
on all animals at terminal sacrifice.
All animals survived test substance administration and gained body weight during the study.
Apart from one animal exhibiting erythema on Day I, there were no other adverse clinical
findings recorded for any animals over the course of the study. No gross abnormalities were
noted for any of the animals when necropsied at the conclusion of the l4-day observation period.
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