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EC number: 201-607-5 | CAS number: 85-44-9
- 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
In a study conducted in male rats, an oral LD50 = 1530 mg/kg bw was found. This value is supported by several other studies in which a LD50 value was found in a similar range, however these studies are not reliable due to limited documentation.
In a valid study for acute inhalation toxicity a LC50 > 2.14 mg/L (highest technically feasible concentration) was found. All animals (except one) survived the post-exposure period. Clinical signs and necropsy revealed no indication that this concentration might be fatal. Therefore it can be concluded, that the LC50 value is much higher than the technically feasible concentration of the experiment. A classification for acute inhalation toxicity is no justified. No valid studies are available with dermal exposure. From 2 not reliable studies, a dermal LD50 > 3160 mg/kg bw and > 10000 mg/kg bw was indicated.
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: Gross or histopathological examination was not performed, big volumes of DMSO was used as a solvent
- Principles of method if other than guideline:
- Ten male rats/dose (bw: ca. 160-180 g), single oral application by gavage, substance dissolved in DMSO (2 ml/100 g bw), observation time: 14 d, calculation of LD50 according to Fink (1965) Arzneim.-Forsch. 15, 624
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- male Wistar-II-rats, SPF, weight 160 - 180 gr, husbandry: 5 animals per cage
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- no further data
- Doses:
- 100, 500, 1000, 2000, 3100, 5000 mg/kg bw in DMSO
- No. of animals per sex per dose:
- 10 males per dose
- Control animals:
- not specified
- Details on study design:
- No further data
- Statistics:
- According Fink and Hund, Arzneimittelforsch. (1965), 15, 624
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 530 mg/kg bw
- Mortality:
- Dose 100 mg/kg, mortality 0/10; dose 500 mg/kg, mortality 2/10; dose 1000 mg/kg, mortality 2/10, dose 2000 mg/kg, mortality 4/10; dose 3100 mg/kg, mortality 9/10; dose 5000 mg/kg, mortality 10/10
- Clinical signs:
- other: Sedation, disturbances of equilibrium
- Gross pathology:
- no data
- Other findings:
- See: Any other information on results including tables
- Interpretation of results:
- Category 4 based on GHS criteria
- Executive summary:
Method: single orale application per gavage of test substance (dose 100, 500, 1000, 2000, 3100, 5000 to 10 male rats, post-observation time 14 days)
Result: LD50 = 1530 mg/kg bw (male rats)
Reference: Loeser (Bayer AG), 1978
Reference
Dose-group, time of death, No of rats which died, No of rats with
symptoms:
100 mg/kg bw, no deaths, 0/10, 0/10
500 mg/kg bw, 3-4 d, 2/10, 10/10
1000 mg/kg bw, 3 d, 2/10, 10/10
2000 mg/kg bw, 2-3 d, 4/10, 10/10
3100 mg/kg bw, 2-3 d, 9/10, 10/10
5000 mg/kg bw, 2 d, 10/10, 10/10
Symptoms: sedation, imbalance, and bloody eyes.
No gross or histopathological examination.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 530 mg/kg bw
- Quality of whole database:
- Scientifically acceptable and sufficient for assessment
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Principles of method if other than guideline:
- Ten healthy rats (5/sex) were exposed nose-only to a test atmosphere of phthalic anhydride of 2.14 mg/L (highest technically feasible concentration) for 4 hours. The animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days following exposure or until death occurred. Body weights were recorded prior to exposure and again on Days 7 and 14 (termination) or after death. Necropsies were performed on all animals.
- GLP compliance:
- yes
- Test type:
- other: highest technically feasible concentration used
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 2.14 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.14 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The exact LC50 cannot be determined.
LC50 > 2.14 mg/L (aerosol) - highest technically feasible concentration. - Executive summary:
Method: according OECD 403 - ten healthy rats (5/sex) were exposed nose-only to a test atmosphere of phthalic anhydride of 2.14 mg/L (highest technically feasible concentration) for 4 hours.
Result: LC50 > 2.14 mg/L (aerosol) - following exposure, the clinical signs observed for the surviving animals included hypoactivity, abnormal respiration, reduced fecal volume, ocular discharge and facial and/or anogenital staining. However they recovered by Day 14. Although three animals lost weight by Day 7, all surviving animals gained body weight over the 14-day observation period. Gross necropsy of the decedent revealed discoloration of the lungs and liver. No gross abnormalities were noted for any of the euthanized animals when necropsied at the conclusion of the 14-day observation period.
Reference
One male died upon chamber removal. There were no clinical signs noted for this animal prior to death. Following exposure, the clinical signs observed for the surviving animals included hypoactivity, abnormal respiration, reduced fecal volume, ocular discharge and facial and/or anogenital staining. However they recovered by Day 14. Although three animals lost weight by Day 7, all surviving animals gained body weight over the 14-day observation period. Gross necropsy of the decedent revealed discoloration of the lungs and liver. No gross abnormalities were noted for any of the euthanized animals when necropsied at the conclusion of the 14-day observation period.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 2 140 mg/m³ air
- Quality of whole database:
- GLP guideline study
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a study conducted in male rats, an oral LD50 = 1530 mg/kg bw was found. This value is supported by several other studies in which a LD50 value was found in a similar range, however these studies are not reliable due to limited documentation.
In a valid study for acute inhalation toxicity a LC50 > 2.14 mg/L (highest technically feasible concentration) was found. All animals (except one) survived the post-exposure period. Clinical signs and necropsy revealed no indication that this concentration might be fatal. Therefore it can be concluded, that the LC50 value is much higher than the technically feasible concentration of the experiment. A classification for acute inhalation toxicity is no justified.
No valid studies are available with dermal exposure. From 2 not reliable studies, a dermal LD50 > 3160 mg/kg bw and > 10000 mg/kg bw was indicated.
Justification for classification or non-classification
An LD50 of 1530 (oral, rat, male) was found in a valid study, therefore a classification Category 4, H302 is justified.
Due to the result of a valid acute inhalation toxicity study and by a weight of evidence consideration of the acute dermal toxicity studies, a classification is not justified.
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