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EC number: 240-994-5 | CAS number: 16926-87-7
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March - May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- October 2008
- Deviations:
- yes
- Remarks:
- Due to technical reason, relative humidity values (maximum of 79 %) outside the expected range of 30-70 % were recorded during observation period. This deviation has no presumed impact on the outcome or integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 2-hydroxy-3-phenoxypropyl methacrylate
- EC Number:
- 240-994-5
- EC Name:
- 2-hydroxy-3-phenoxypropyl methacrylate
- Cas Number:
- 16926-87-7
- Molecular formula:
- C13H16O4
- IUPAC Name:
- 2-hydroxy-3-phenoxypropyl 2-methylprop-2-enoate
- Reference substance name:
- 1-chloro-3-phenoxypropan-2-ol
- EC Number:
- 225-310-5
- EC Name:
- 1-chloro-3-phenoxypropan-2-ol
- Cas Number:
- 4769-73-7
- Molecular formula:
- C9H11ClO2
- IUPAC Name:
- 1-Chloro-3-phenoxy-2-propanol
- Test material form:
- liquid
Constituent 1
impurity 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
171512
- Expiration date of the lot/batch:
23 December 2019
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Room temperature (15-25ºC, ≤ 70 RH%), protected from humidity (tigh closed container)
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Final dilution of a dissolved solid, stock liquid or gel:
200 mg/mL in the vehicle
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
Charles River Laboratories, Research Model and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation:
9-12 weeks old
- Weight at study initiation:
205-260 g
- Fasting period before study:
- Housing:
Individual caging (1 animal/cage)
- Diet: ssnif SM R/M "Autoclavable complete diet for rats and mice - breeding and maintenance" Batch number 382 24962, expiry date 30 April 2018 and Batch umber 883 29966, expiry date 31 October 2018. Fed ad libitum
- Water (e.g. ad libitum):
tap water from the municipal supply as for human consumption from 500 ml bottles, ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 25.0 ºC
- Humidity (%): 37-79 %
- Air changes (per hr): 15-20 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 22 March 2018 To: 08 May 2018
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no. (if required): BCBS1795V
- Expiry date: 31 May 2018 - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology,
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- PHPM did not cause any mortality at a dose level of 2000 mg/kg bw.
- Clinical signs:
- other: At the dose level of 2000 mg/kg bw, the following test item related symptoms were observed on Day 0: slightly decreased activity (2 out of 5 animals), piloerection (4 out of 5 animals), hunched back (4 out of 5 animals) and slight incoordination (5 out of
- Gross pathology:
- There was no evidence of treatment-related macroscopic changes at a dose level of 2000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item PHPM was found to be above 2000 mg/kg bw in female Crl:WI rats.
- Executive summary:
SUMMARY
An acute oral toxicity (up and down procedure) study was conducted with 5 female Crl:WI rats. Animals were treated with a single oral (gavage) dose of PHPM, at a dose level of 2000 mg/kg body weight (bw) followed by a 14-day observation period. The animals were fasted overnight prior to treatment and food was returned 3 hours after dosing.
Individual animals were dosed sequentially at no less than 48 hour intervals. The time intervals between doses were determined by the onset, duration and severity of clinical signs.
Animals were observed individually after dosing at 30 minutes, then 1, 2, 3, 4 and 6 hours post treatment and once each day for 14 days thereafter. Body weight was measured on Day -1, just before dosing and weekly thereafter. All animals were examined macroscopically at the end of the observation period.
Results
Mortality
The treatment with PHPM did not cause any mortality at a dose level of 2000 mg/kg bw.
Clinical Observations
At the dose level of 2000 mg/kg bw, the following test item related symptoms were observed on Day 0: slightly decreased activity (2 out of 5 animals), piloerection (4 out of 5 animals), hunched back (4 out of 5 animals) and slight incoordination (5 out of 5 animals). From Day 1 all the animals were symptom-free.
Body Weight and Body Weight Gain
One female animal showed slight body weight loss during the second week of the observation period. This change was considered incidental and minimal and not ascribed to treatment. There was no other treatment related effects on body weight or body weight gain during the observation period.
Macroscopic Findings
There was no evidence of treatment-related macroscopic changes at a dose level of 2000 mg/kg bw.
Conclusion:
Under the conditions of this study, the acute oral LD50 value of the test item PHPM was found to be above 2000 mg/kg bw in female CRL:WI rats.
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