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EC number: 601-596-0 | CAS number: 119302-24-8
- 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
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:
- 20 July 1999 - 5 August 1999
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles Rive Deutschland, Sulzfeld, Germany
- Age at study initiation: 8 weeks
- Weight at study initiation: Male mean: 292 grams; Female mean 203 grams
- Fasting period before study: overnight before dosing and 3-4 hours after dosing.
- Housing: Group housing of 3 animals per sex in polycarbonate cages.
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet (Carfil Quality BVBA, Oud-Turnhout, Belgium).
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50%
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 July 1999 To: 5 August 1999 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: Vehicle was selected based on a pretest performed at NOTOX.
MAXIMUM DOSE VOLUME APPLIED:
2000 mg/kg (10 mL/kg) body weight - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality/Viability - Twice daily; Body weights - Days 1 (pre-administration), day 8, and day 15; Clinical signs - periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: Internal macroscopic abnormalities - Statistics:
- Not applicable
- Preliminary study:
- As the 2000 mg/kg limit test resulted in no adverse effects, or mortalities in this study group, no additional dose levels were required.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was reported within this study.
- Clinical signs:
- other: Diarrhea, red staining of the eye, hunched posture and/or piloerection were noted among the animals between day 2 and 4. Alopecia, was noted during the observation period, and is commonly seen in group housed rats and therefore was not counted as toxicolo
- Gross pathology:
- Macroscopic examination of animals reported irregular surface of the fore-stomach in three males and one female. In one female the serosa and the liver were reported to be grown together. In one male the serosa was reported to be grown together with the diaphram and liver.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 for the test substance, when administered as supplied to rats, is >2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Dose descriptor:
- LC50
- Value:
- 2 000
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 - 25 August 1999
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 9 weeks old
- Weight at study initiation: <3.5 kg
- Fasting period before study: none
- Housing: Individually housed in polycarbonate cages
- Diet (e.g. ad libitum): free access to standard pelleted laboratory animal diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: none
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 degrees C
- Humidity (%): 50%
- Air changes (per hr): 15 air changes per hr
- Photoperiod (hrs dark / hrs light): Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.
IN-LIFE DATES: From: To: 17 August 1999 to 20 August 1999 - Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back
- % coverage: 10% total body surface
- Type of wrap if used: Wrap consisted of surgical gauze patch, successively covered with aluminium foil and Coban flexible bandage. Micropore tape was used in females for fixation of bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Concentration (if solution): No data
- Constant volume or concentration used: Yes
- For solids, paste formed: No data - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality/Viability - Twice daily; Body Weight - Days 1 (pre-administration), 8 and 15; Clinical Signs - At periodic intervals on the day of dosing and once daily thereafter, until day 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: Internal macroscopic abnormalities. - Statistics:
- Not applicable
- Preliminary study:
- The test substance, when administered as supplied to rats, indicated an acute dermal LD50 greater than 2000 mg/kg.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Mortality:
- No mortality occurred
- Clinical signs:
- other: No signs of systemic toxicity were reported. Alopecia, focal erythema, necrosis and/or scabs were seen in the treated skin-area of the animals during the observation period.
- Gross pathology:
- Macroscopic findings were only noted in two males; for one male liver nodules and a hernia of the diaphragm were reported and for the other male a thickened enlarged liver was reported.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test substance, when administered as supplied to rats, was greater than 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
Additional information
The acute oral LD50 for Pymorolac, when administered as supplied to rats, was >=2000 mg/kg bw.
Justification for selection of acute toxicity – dermal endpoint
The acute dermal LD50 of Pymorolac, when administered as supplied to rats, was >= 2000 mg/kg bw.
Justification for classification or non-classification
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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