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EC number: 201-873-2 | CAS number: 88-99-3
- 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 toxicity of Phthalic Acid is low. LD50 values >2000 mg/kg were reported in mice and rats.
In an acute inhalation study in rats, the aerolized test substance proved to have essentially no acute inhalation toxicity. The LC50 was >5058 mg/m³ in male and female rats.
There are no data on acute dermal toxicity available.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD guideline or GLP defined. No doses defined.
- Principles of method if other than guideline:
- male and female albino mice weighing 18-20 g, were used. The animals were fasted for a period of 4-16 h prior to treatment. Range-finding tests of the acute toxicity were conducted initially. 5% gum acacia was used as the vehicle. All surviving animals were maintained for a subsequent 14-day period. The LD50 was calculated from the mortality data.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- mouse
- Strain:
- other: albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Breeder: Canadian Breeding Laboratories and Charles River Laboratories
weight at study initiation: 18-20g
fasting period: 4 to 16 hours prior to treatment - Route of administration:
- oral: unspecified
- Vehicle:
- other: 5% gum acacia
- Details on oral exposure:
- All surviving animals were maintained for a subsequent 14-day period. The LD50 was calculated from the mortality data according to Lichfield and Wilcoxan (1949).
- Doses:
- no data
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Executive summary:
In an acute oral toxicity study in male and female albino mice the LD50 was >5000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: insufficient data documentation
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
- Test type:
- other: Acute oral toxicity in rats
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- no data
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 8 000 mg/kg bw
- Executive summary:
In an acute oral toxicity study the LD 50 in rats was 8000 mg/kg bw.
Referenceopen allclose all
Phthalic acid, Mouse,LD50= >5000 mg/kg bw
no data
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- other: Acute inhalation toxicity study in rats
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Hsd Cpb:WU (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Nederland, AD Horst
- Age at study initiation: approximately 2 months
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3°C
- Humidity (%): 40-60%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 2010 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Remark on MMAD/GSD:
- The respirability of the aerosol was adequate, i.e. the mass median aerodynamic diameter (MMAD) was 3.1µm, the geometric standard deviation (GSD) was 1.9).
Test item was micronized. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- stability was certified for the duration of the study
- Duration of exposure:
- 4 h
- Concentrations:
- 5058 mg/m³
- No. of animals per sex per dose:
- 3
- Control animals:
- yes
- Details on study design:
- The respirability of the aerosol was adequate, i.e. the mass median aerodynamic diameter (MMAD) was 3.1µm, the geometric standard deviation (GSD) was 1.9).
Body weights were measured before exposure, on days 1, 3, 7 and weekly thereafter. 2 week observation period. - Statistics:
- yes
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 058 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- Mortality did not occur up the maximum technically attainable concentration.
- Clinical signs:
- other: bradypnea, irregular breathing patterns, labored breathing patterns, nasal discharge (serous), nose: red encrustations, muzzle: red encrustations; motility reduced, limp, tremor, high-legged gait, lurching, piloerection, cyanosis, and hypothermia
- Remarks:
- non-specific effects, related to the high concentration of dry, highly respirable dust 'overloading' to some extent the upper airways of the respiratory tract
- Body weight:
- no changes in body weight of toxicological significance
- Gross pathology:
- The macroscopic findings were essentially indistinguishable amongst exposure and control group.
- Other findings:
- no changes in reflexes investigated on the first post-exposure day; rectal temperature significantly reduced in exposed animals
- Executive summary:
A study on the acute inhalation toxicity of Phthalic acid on rats has been conducted in accordance with the EU Directive 92/69/EEC, and especially OECD GD 403 (2009). One group of rats was nose-only exposed to powder aerosol in concentrations of 5058 mg/m³. The powder aerosol was generated so that it was respirable to rats. Mortality did not occur up the maximum technically attainable concentration. Rats exposed at 5058 mg/m³ displayed the following signs (exposure day up to second post exposure day): bradypnea, irregular breathing patterns, labored breathing patterns, nasal discharge (serous), nose: red encrustations, muzzle: red encrustations; motility reduced, limp, tremor, high-legged gait, lurching, piloerection, cyanosis, and hypothermia. The respirability of the aerosol was adequate, i.e. the mass median aerodynamic diameter (MMAD) was 3.1µm, the geometric standard deviation (GSD) was 1.9).
The results can be summarized as follows:
LC50 inhalation (powder aerosol, 4h), male/female rat: >5058 mg/m³.
NOAEL male and female rat: <5058 mg/m³
The aerolized test substance proved to have essentially no acute inhalation toxicity in rats.
Reference
Summary of acute inhalation toxicity-4 hour exposure (aerosolization of the micronized test article powder):
No of animals, sex | Target concentration (mg/m³) | Toxicological Result | Onset and duration of Signs | Onset and Duration of Mortality | Rectal Temperature |
5 m | 0 | 0 / 0 / 5 | - | - | 37.9 |
3 m | 5000 | 0 / 3 / 3 | 0d-1d | - | 30.1** |
5 f | 0 | 0 / 0 / 5 | - | - | 38.4 |
3 f | 5000 | 0 / 3 / 3 | 0d-2d* | - | 33.3** |
N- group assignment, m= males, f=females.
*- one female rat showed hairless areas (from day 1 -14) which is not considered to be substance-related and therefore is not concluded in the incidence tables.
**- p<0.01
´Toxicological results´ colum are: 1st= number of dead animals, 2nd= number of animals with signs after cessation of exposure; 3rd= number of animals exposed.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 058 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a study conducted in male and female albino mice, an oral LD50 >5000 mg/kg bw was found (Schoneker, 2002).
In a second study in mice the LD50 was found to be 2530 mg/kg bw (Lin, 1982).
These values are supported by 2 studies in rats in which LD50 values were found to be 8000 and 7900 mg/kg respectively (Tomita, 1978; Giam, 1984), however the reliability of these studies can not be assessed due to limited documentation.
A study on the acute inhalation toxicity of Phthalic acid on rats has been conducted in accordance with the EU Directive 92/69/EEC, and especially OECD GD 403 (2009). One group of rats was nose-only exposed to powder aerosol in concentrations of 5058 mg/m³. The powder aerosol was generated so that it was respirable to rats. Mortality did not occur up the maximum technically attainable concentration. Rats exposed at 5058 mg/m³ displayed the following signs (exposure day up to second post exposure day): bradypnea, irregular breathing patterns, labored breathing patterns, nasal discharge (serous), nose: red encrustations, muzzle: red encrustations; motility reduced, limp, tremor, high-legged gait, lurching, piloerection, cyanosis, and hypothermia. The respirability of the aerosol was adequate, i.e. the mass median aerodynamic diameter (MMAD) was 3.1µm, the geometric standard deviation (GSD) was 1.9).
The results can be summarized as follows:
LC50 inhalation (powder aerosol, 4h), male/female rat: >5058 mg/m³.
NOAEL male and female rat: <5058 mg/m³
The aerolized test substance proved to have essentially no acute inhalation toxicity in rats (Pauluhn, 2009).
There are no data on acute dermal toxicity available.
Justification for classification or non-classification
Based on the available studies, the test substance needs no classification for acute toxicity according to EU Regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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