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EC number: 241-045-8 | CAS number: 16969-10-1
- 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
Endpoint summary
Administrative data
Description of key information
Acute toxicity potentiel of 2 -Hydroxy-3 -phenoxypropyl acrylate was evaluated by oral route only. The oral LD50 is higher than 2000 mg/kg in rat. No data is available by dermal route or by inhalation.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 June 2015 - 22 July 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 8 weeks old on the day of treatment
- Mean body weight at study initiation: 201 g (range: 191 g to 214 g)
- Fasting period before study: yes, during the night before treatment
- Housing: the animals were housed in threes from the same group in polycarbonate cages with stainless steel lids (Tecniplast 2154, 940 cm²)
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 8 to 15 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h.
IN-LIFE DATES: 17 June 2015 to 22 July 2015. - Route of administration:
- oral: gavage
- Vehicle:
- other: methylcellulose in solution at 0.5%
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Maximum dose-volume applied: 10 mL/kg
DOSAGE PREPARATION (if unusual): The test item was administered as a homogenous emulsion in the vehicle. The test item was mixed with the required quantity of vehicle.
Fresh dose formulations were prepared by the CiToxLAB France Pharmacy on the day of each administration and kept at room temperature prior to administration.
CLASS METHOD (if applicable):
- Rationale for the selection of the starting dose: The starting dose-level was selected in agreement with the Sponsor. Since no relevant toxicity data were available for the estimation of a lethal dose-level and any existing data were taken into account by the Sponsor, the starting dose-level was 300 mg/kg for ethical reasons.
After treatment at the starting dose-level, the next dose-levels were administered in a sequential manner, under the same conditions to different animals, based on the dose-levels indicated in the flow charts of OECD Guideline No. 423, 17th December 2001, which are equivalent to those of Commission Regulation (EC) No. 440/2008, B.1tris (30 May 2008). - Doses:
- 300 and 2000 mg/kg.
- No. of animals per sex per dose:
- 3 females per treatment step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight: just before treatment on day 1; then on days 8 and 15.
- Necropsy of survivors performed: yes (macroscopic). - Statistics:
- no
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No unscheduled deaths occurred during the study.
- Clinical signs:
- other: No clinical signs were observed in animals given 300 mg/kg. At 2000 mg/kg, hunched posture was observed in 3/6 females on Day 1. This was associated with staggering gait and piloerection in one of them. These clinical signs were no longer observed from Da
- Gross pathology:
- There were no test item-related gross findings.
- Other findings:
- no
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of 2-Hydroxy-3-phenoxypropyl acrylate was higher than 2000 mg/kg in rats.
- Executive summary:
The objective of this study was to evaluate the potential acute toxicity of the test item following a single oral administration (gavage) to rats.
This study was conducted in compliance with OECD Guideline No. 423 and the principles of Good Laboratory Practices.
Methods
The test item was administered once by oral route (gavage) to three groups of three fasted female Sprague-Dawley rats under a dosage-volume of 10 mL/kg. The test item was prepared in a 0.5% solution of methylcellulose.
Since no relevant toxicity data were available for the estimation of a lethal dose-level and any existing data were taken into account by the Sponsor, the starting dose-level was 300 mg/kg for ethical reasons.After the first assay, the next higher dose-level of 2000 mg/kg was tested. Then, as no toxicity was observed at this higher dose-level, the results were confirmed in other females.
Each animal was observed at least once a day for mortality and clinical signs for 15 days. Body weight was recorded on Day 1 and then on Days 8 and 15.
On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination.Macroscopic lesions were preserved in buffered formalin then destroyed at the finalization of the study report as no microscopic examination was performed.
Results
No unscheduled deaths occurred during the study and no clinical signs were observed in animals given 300 mg/kg.
At 2000 mg/kg, hunched posture was observed in 3/6 females on Day 1. This was associated with staggering gait and piloerection in one of them.These clinical signs were no longer observed from Day 2.
Body weight was unaffected by the test item treatment, when compared to CiToxLAB France historical control data.
There were no test item-related gross findings.
Conclusion
The oral LD50of the test item was higher than 2000 mg/kg in rats.
Therefore, the test item should not be classified as toxic by oral route according to the criteria of CLP Regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The key study is considered to be reliable with a klimish score of 1.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity by oral route :
The objective of this study was to evaluate the potential acute toxicity of the test item following a single oral administration (gavage) to rats.
The key study (Papineau 2015) was conducted in compliance with OECD Guideline No. 423 and the principles of Good Laboratory Practices. The test item was administered once by oral route (gavage) to three groups of three fasted female Sprague-Dawley rats under a dosage-volume of 10 mL/kg. The test item was prepared in a 0.5% solution of methylcellulose.
No unscheduled deaths occurred during the study and no clinical signs were observed in animals given 300 mg/kg. At 2000 mg/kg, hunched posture was observed in 3/6 females on Day 1. This was associated with staggering gait and piloerection in one of them.These clinical signs were no longer observed from Day 2. Body weight was unaffected by the test item treatment, when compared to historical control data. There were no test item-related gross findings. The oral LD0 of the test item was higher than 2000 mg/kg in rats.
In the supporting study (Kirsch 1989a), the test substance induced clinical signs in males and females on the first day after administration. Two males died at the beginning of the study (on day 1 and 2 after administration). Based on this result, the LD50 is higher than 2000 mg/kg.
Justification for classification or non-classification
Based on the available data, no classification for acute toxicity is required for 2 -Hydroxy-3 -phenoxypropyl acrylate according to the Regulation EC n°1272/2008.
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