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EC number: 206-596-0 | CAS number: 355-93-1
- 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
The acute oral LD50 of the substance is greater than 2000 mg/kg bw.
The NOAEL for nose-only vapour inhalation exposure of the test substance to rats for 5 consecutive days was 168 ppm.
Testing by the dermal route does not need to be conducted as the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects after dermal exposure are predicted.
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:
- June 24, 2008 to August 28, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- Adopted December 17, 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- Purity: 99%
Specific Gravity: 1.49 - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyertown, PA
- Females nulliparous and non-pregnant: yes
- Age at study initiation: ~8-9 weeks
- Weight at study initiation: 196-212 grams
- Fasting period before study: 16-20 hours prior to dosing
- Housing: 1/cage
- Diet: ad libitum, except for 16-20 hours prior to dosing
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: June 25, 2008 To: July 10, 2008 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 0.26-0.28 mL
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 females/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed 0.5, 1, 2, and 4 hours postdose and once daily for 14days for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality reported
- Mortality:
- All animals survided the 2000 mg/kg oral dose
- Clinical signs:
- other: Instances of wetness of the anogenital area, ataxia, prostration, flaccid muscle tone and coma were noted on the day of dosing. All animals appeared normal from day 1 through day 14.
- Gross pathology:
- Necropsy results were normal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- All animals survived the 2000 mg/kg oral dose with transient clinical signs observed during the day of dosing. The symptoms occurred quickly after dosing and were transient in nature. The acute oral LD50 is greater than 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the substance was investigated following a GLP compliant OECD Guideline 425 study. In total, five female non-pregnant and nulliparous Wistar albino rats were dosed with 2000 mg/kg bw of OFPMA according to up-and-down procedure. The rats were observed at 0.5, 1, 2, and 4 hours post dose and once daily for 14 days for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination. All animals were examined for gross pathology.
All animals survived the 2000 mg/kg bw oral dose with transient clinical signs observed during the day of dosing. Instances of wetness of the anogenital area, ataxia, prostration, flaccid muscle tone and coma were noted on the day of dosing. The symptoms occurred quickly after dosing and were transient in nature. All animals appeared normal from day 1 through day 14. Body weight changes were normal in 4/5 animals. One animal lost weight during the second week of the observation period. Necropsy results were normal.
The acute oral LD50 of the substance is greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The database is robust given the number and type of studies available, and consistency of findings
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Remarks:
- 5-day tolerability study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 July 2009 to 31 August 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Guideline:
- other: In-house nose-only inhalation study
- Principles of method if other than guideline:
- In-house protocol. The test substance was administered to test animals via nose-only inhalation for 6 hours per day for 5 consecutive days at targeted dose levels of 42, 84 and 168 ppm. A concurrent control group was exposed to filtered air on a comparable regimen. On the day following the fifth exposure, all test animals were euthanized and subjected to necropsy.
- GLP compliance:
- yes
- Test type:
- other: 5-day tolerability study
- Limit test:
- no
- Specific details on test material used for the study:
- - Source and lot/batch No.of test material: Lot no. 900638318
- Purity: 99.7% - Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, NC
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 7-9 weeks of age at initiation of exposures
- Weight at study initiation: Males - 206-251 g; Females - 147-181 g
- Housing: housed individually
- Diet: ad libitum throughout the study except during restraint acclimation, exposure periods, and prior to the scheduled necropsy.
- Water: ad libitum throughout the study except during restraint acclimation, exposure periods, and prior to the scheduled necropsy.
- Acclimation period: 12 days acclimation/pretest period; 5 days in nose-only exposure tubes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2 °C to 21.8 °C
- Humidity (%): 43.1% to 47.5%
- Air changes: a minimum of 10 fresh air changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 26 July 2009 To: 31 July 2009 - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose only
- Vehicle:
- other:
- Remarks:
- nitrogen gas mixed with filtered air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
Vapors of the test substance were generated using 1-, 2-, and 3-jet Collison nebulizer for Exposure Systems 2, 3, and 4, respectively as follows: Using a regulator compressed nitrogen was supplied to the nebulizer to generate an aerosol of the test substance. Additional test substance was manually added to the nebulizer during the exposure as needed. Prior to entering the nose-only system, all test substance aerosol was vaporized or removed by a liquid trap. A siphon was placed in-line prior to the nose-only system to adjust the concentration as needed. Using a rotameter-type flow meter, a portion of the test substance atmosphere was siphoned to the in-house vacuum source. Filtered supply air was mixed with the test substance atmosphere prior to entering the nose-only system. Control animals were exposed to compressed nitrogen mixed with filtered supply air using an exposure regimen equivalent to the test substance exposures. Aerosol formation was not observed in any test substance exposure system.
TEST ATMOSPHERE
- Brief description of analytical method used: Analyzed exposure concentrations were determined at approximately 35-minute intervals using a gas chromatograph (GC)
- Samples taken from breathing zone: yes - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 6 h
- Remarks on duration:
- The test substance or compressed air (control group) was administered as a daily 6-hour nose-only in halation exposure for 5 consecutive days.
- Concentrations:
- Nominal: 81, 169, 219 ppm; Targeted: 42, 84, 168 ppm; Actual: 40, 89, 168 ppm
The test substance exposure concentrations were selected by the Sponsor based on toxicity information from structurally related materials and levels needed to provide adequate safety margins based on estimated human exposure levels. - No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes
- Remarks:
- concurrent control group was exposed to filtered air on a comparable regimen
- Details on study design:
- All animals were observed twice daily, once in the morning and once in the afternoon, for mortality and moribundity.
Clinical examinations were performed 3 times daily, prior to exposure, during exposure (at the approximate midpoint), and approximately 0-1 hour following the end of exposure (designated as 1-hour post-exposure for report presentation purposes).
Individual body weights were recorded during the pretest period, prior to randomization, and prior to the first (study day 0) and last (study day 4) exposures. Final body weights (fasted) were recorded on the day of the scheduled necropsy.
Individual food consumption was recorded for 1 week during the pretest period and on study days 0 and 4.
A complete necropsy was conducted on all animals. The following were collected: kidneys, larynx, liver, and lungs.
Liver and lung weights were recorded at scheduled necropsy. - Statistics:
- All statistical tests were performed using appropriate computing devices or programs.
- Key result
- Sex:
- male/female
- Dose descriptor:
- other: NOAEL
- Remarks:
- 5 days
- Effect level:
- 168 ppm
- Based on:
- test mat.
- Exp. duration:
- 6 h
- Remarks on result:
- other: 5-day tolerability study
- Mortality:
- No mortality observed
- Clinical signs:
- other: All clinical findings in the test substance-treated groups were noted with similar incidence in the control group, were limited to single animals, were not noted in a dose-related manner and/or were common findings for laboratory rats of this age and stra
- Body weight:
- No effects observed
- Gross pathology:
- There were no test substance-related macroscopic findings at the scheduled necropsy. All macroscopic findings noted were considered to be spontaneous and/or incidental in nature and unrelated to test substance administration.
- Other findings:
- There were no test substance-related microscopic findings. All findings observed were consistent with normal background lesions in clinically normal rats of the age and strain used on this study and were considered spontaneous and/or incidental in nature and unrelated to test substance administration.
No effects observed for organ weight findings. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, exposure of rats to the test substance via 6-hour nose-only inhalation for 5 consecutive days at exposure concentrations ≤168 ppm did not result in any test substance-related effects or dose-limiting toxicity. Therefore, the no-observed-adverse-effect level (NOAEL) for nose-only inhalation exposure of the test substance to rats for 5 consecutive days was 168 ppm, the highest exposure concentration tested.
- Executive summary:
The test substance was administered via nose-only inhalation for 6 hours per day for 5 consecutive days to 3 groups (Groups 2, 3, and 4) of rats. Target exposure concentrations were 42, 84, and 168 ppm for Groups 2, 3, and 4, respectively. A concurrent control group (Group 1) was exposed to filtered air on a comparable regimen. Each group consisted of 5 animals/sex. On the day following the fifth exposure, all animals were euthanized and subjected to necropsy.
The animals were observed twice daily for mortality and moribundity. Clinical examinations were performed 3 times daily (prior to exposure, at the approximate exposure midpoint, and approximately 0 to 1 hour following the end of exposure), and detailed physical examinations were performed for randomization and during the exposure phase on study days 0 and 4. Individual body weights and food consumption were recorded at least weekly during the pretest phase and on study days 0 and 4. Complete necropsies were performed on all animals, and the liver, lungs, and kidneys were weighed at the scheduled necropsy. The kidneys, larynx, liver, lungs, nasal cavity (with turbinates), pharynx, trachea, and urinary bladder were examined microscopically from all animals in the control and 168 ppm group (Groups 1 and 4, respectively). Gross lesions were examined microscopically from all animals (when possible).
There were no test substance-related effects on survival or clinical observations. There were no apparent test substance-related effects on body weights, body weight changes, food consumption, organ weights, or macroscopic and microscopic findings at any exposure concentration.
Based on the results of this study, exposure of rats to the test substance via 6-hour nose-only inhalation for 5 consecutive days at exposure concentrations≤168 ppm did not result in any test substance-related effects or dose-limiting toxicity. Therefore, the no-observed-adverse-effect level (NOAEL) for nose-only inhalation exposure of the test substance to rats for 5 consecutive days was 168 ppm, the highest vapour exposure concentration tested. Applying the ideal gas law, the NOAEL for nose-only inhalation exposure of the test substance to rats for 5 consecutive days was 2 mg/L, the highest vapour exposure concentration tested.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The database is robust given the number and type of studies available, and consistency of findings.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral Toxicity:
The acute oral toxicity of the substance was investigated following a GLP compliant OECD Guideline 425 study. In total, five female non-pregnant and nulliparous Wistar albino rats were dosed with 2000 mg/kg bw of OFPMA according to up-and-down procedure. The rats were observed at 0.5, 1, 2, and 4 hours post dose and once daily for 14 days for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Body weights were recorded immediately pre-test, weekly and at termination. All animals were examined for gross pathology.
All animals survived the 2000 mg/kg bw oral dose with transient clinical signs observed during the day of dosing. Instances of wetness of the anogenital area, ataxia, prostration, flaccid muscle tone and coma were noted on the day of dosing. The symptoms occurred quickly after dosing and were transient in nature. All animals appeared normal from day 1 through day 14. Body weight changes were normal in 4/5 animals. One animal lost weight during the second week of the observation period. Necropsy results were normal.
The acute oral LD50 of the substance is greater than 2000 mg/kg bw.
Inhalation Toxicity
The test substance was administered via nose-only inhalation for 6 hours per day for 5 consecutive days to 3 groups (Groups 2, 3, and 4) of rats. Target exposure concentrations were 42, 84, and 168 ppm for Groups 2, 3, and 4, respectively. A concurrent control group (Group 1) was exposed to filtered air on a comparable regimen. Each group consisted of 5 animals/sex. On the day following the fifth exposure, all animals were euthanized and subjected to necropsy.
The animals were observed twice daily for mortality and moribundity. Clinical examinations were performed 3 times daily (prior to exposure, at the approximate exposure midpoint, and approximately 0 to 1 hour following the end of exposure), and detailed physical examinations were performed for randomization and during the exposure phase on study days 0 and 4. Individual body weights and food consumption were recorded at least weekly during the pre-test phase and on study days 0 and 4. Complete necropsies were performed on all animals, and the liver, lungs, and kidneys were weighed at the scheduled necropsy. The kidneys, larynx, liver, lungs, nasal cavity (with turbinates), pharynx, trachea, and urinary bladder were examined microscopically from all animals in the control and 168 ppm group (Groups 1 and 4, respectively). Gross lesions were examined microscopically from all animals (when possible).
There were no test substance-related effects on survival or clinical observations. There were no apparent test substance-related effects on body weights, body weight changes, food consumption, organ weights, or macroscopic and microscopic findings at any exposure concentration.
Based on the results of this study, exposure of rats to the test substance via 6-hour nose-only inhalation for 5 consecutive days at exposure concentrations ≤168 ppm did not result in any test substance-related effects or dose-limiting toxicity. Therefore, the no-observed-adverse-effect level (NOAEL) for nose-only inhalation exposure of the test substance to rats for 5 consecutive days was 168 ppm, the highest vapour exposure concentration tested. Applying the ideal gas law, the NOAEL for nose-only inhalation exposure of the test substance to rats for 5 consecutive days was 2 mg/L, the highest vapour exposure concentration tested.
Dermal Toxicity
Testing by the dermal route does not need to be conducted as the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects after dermal exposure are predicted.
Justification for classification or non-classification
The acute oral LD50 of the substance is greater than 2000 mg/kg bw. Therefore, the substance does not fulfil the criteria for acute oral toxicity classification according to European CLP Regulation (EC) No 1272/2008 (as amended).
Testing by the dermal route does not need to be conducted as the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects after dermal exposure are predicted. Therefore, the substance does not fulfil the criteria for acute dermal toxicity classification according to European CLP Regulation (EC) No 1272/2008 (as amended).
The acute NOAEL following 6-hour exposure to the vapour was 168 ppm (approximately 2 mg/L); the highest vapour exposure concentration tested. No deaths and no clinical signs were reported. Therefore, the substance does not fulfil the criteria for acute inhalation toxicity classification according to European CLP Regulation (EC) No 1272/2008 (as amended).
An assessment of the whole database supports the non-classification for STOT SE. The clinical symptoms observed following single oral exposure occurred quickly after dosing and were transient in nature. Additionally, there were no test substance-related clinical observations following inhalation of vapours for six hours a day for five consecutive days at a maximum of 168 ppm. Overall, the transient nature of the reported clinical signs and consideration of the database as a whole do not fulfil the criteria for STOT SE classification according to European CLP Regulation (EC) No 1272/2008 (as amended).
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