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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
Acute Toxicity: inhalation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Phthalic acid
- EC Number:
- 201-873-2
- EC Name:
- Phthalic acid
- Cas Number:
- 88-99-3
- Molecular formula:
- C8H6O4
- IUPAC Name:
- benzene-1,2-dicarboxylic acid
- Details on test material:
- Phthalic Acid LP RJE 73330, Stability certified for the duration of study.
Constituent 1
Test animals
- 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
Administration / exposure
- 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
Results and discussion
Effect levels
- 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
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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.
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