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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
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 - 20 August 1999
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 6 weeks old
- Weight at study initiation: Mean less than 3.5 kg
- Housing: Individually in cages with perforated floors
- Diet: 100 g/day of Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany). Once/week hay was provided (BMI, HElmond, the Netherlands).
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50%
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1999-08-17 August To: 1999-08-20 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 grams - Duration of treatment / exposure:
- 4 Hours
- Observation period:
- 72 Hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Flank
- coverage: 2x3 cm
- Type of wrap if used: Metalline patch mounted on Micropore tape and secured using Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water
- Time after start of exposure: 4 hrs
SCORING SYSTEM: See free text field below - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 Hours
- Score:
- >= 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 Hours
- Score:
- >= 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No skin irritation or corrosion was caused by the 4 hours of exposure to the test substance at 0.5 grams.
- Other effects:
- No symptoms of systemic toxicity were observed in the rabbits during the test period and no mortality was reported.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance when administered as supplied to rabbits, at a dosage of 0.5 grams does not cause irritation/corrosion to the animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 August - November 24 1999
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Nederland, Someren, the Netherlands
- Age at study initiation: At least 6 weeks
- Weight at study initiation: Less than 3.5 kg
- Housing: Individually in cages with perforated floors
- Diet: Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100 g per day.
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ˚C
- Humidity (%): 50%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 34.5 +/- 0.7 mg (volume of approximately 0.1 mL) - Duration of treatment / exposure:
- 48 hours
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsed with approx 50 mL tepid tap-water
- Time after start of exposure: observations were done at 24 hrs and then the substance was rinsed from the eyes
SCORING SYSTEM: See "Any other information on materials and methods incl. tables".
TOOL USED TO ASSESS SCORE: Ophthalmic examination lamp. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animal 501
- Time point:
- other: 24-72 hours
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animal 503
- Time point:
- other: 24-72 hours
- Score:
- ca. 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animal 513
- Time point:
- other: 24-72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Animal 501, 503, 513
- Time point:
- other: 24-72 hours
- Score:
- ca. 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- Animal 501
- Time point:
- other: 24-72 hours
- Score:
- ca. 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- Animal 503
- Time point:
- other: 24-72 hours
- Score:
- ca. 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- Animal 513
- Time point:
- other: 24-72 hours
- Score:
- ca. 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal 501
- Time point:
- other: 24-72 hours
- Score:
- ca. 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal 503
- Time point:
- other: 24-72 hours
- Score:
- ca. 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal 513
- Time point:
- other: 24-72 hours
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Opacity and epithelial damage of the corneal was observed in two animals and was resolved within 7 days with one and 72 hours in the other. All animals reported iridial irritation, which was resolved within 72 hours.
Irritation of the conjunctivae was reported in all animals, this was resolved within 7 days in two animals and within 14 days in the other animals. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test substance is considered an eye irritant according to Regulation (EC) 1272/2008 (CLP) (H319) because at 2 of hte three animals tested had a conjunctival redness score greater than 2 (of a possible 4), which aligns with the GHS and CLP criteria for eye irritant Cat 2.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
GLP study according to OECD Guideline 405. Pymorolac when administered as supplied to rabbits, at a dosage of 0.5 grams does not cause irritation/corrosion to the animals.
Justification for selection of eye irritation endpoint:
GLP study according to OECD Guideline404 and EU Method B.4. Under the conditions of this study, the test substance was not considered an eye irritant.
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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