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EC number: 255-980-4 | CAS number: 42872-29-7
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start of experimental phase: 09 October 2008 - End of experimental phase: 14 November 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to international guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- other: The Rules governing Medicinal Products in the European Community, Vol. 3B (1998)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 3-(1-cyanoethyl)benzoyl chloride
- EC Number:
- 255-980-4
- EC Name:
- 3-(1-cyanoethyl)benzoyl chloride
- Cas Number:
- 42872-29-7
- Molecular formula:
- C10H8ClNO
- IUPAC Name:
- 3-(1-cyanoethyl)benzoyl chloride
- Test material form:
- other: liquid
- Details on test material:
- Name: KETOPROFEN/CFPPN
Synonym: CFPPN-Methylester
Batch number: F-PPR-080059
Expiry date: 12 August 2009
Description: Brown liquid
Storage at RTC : +4°C, protected from light (shipped at room temperature)
RTC reference number: 11437
Certificate of analysis : A certificate of analysis was supplied by the Sponsor (see Attachment I).
Test item characterisation: Not undertaken at the testing facility. The determination of the identity, strength, purity, composition, stability and method of synthesis and/or derivation of the test item was the responsibility of the Sponsor.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animal supply and acclimatisation
Species and strain: Rat, Hsd: Sprague Dawley SD
Number and sex: Females (nulliparous and non-pregnant)
Age and weight range (at order): 6 to 7 weeks old, 150 to 174 grams
Supplier: Harlan Italy S.r.l., 33049 San Pietro al Natisone (UD), Italy
Breeder: Harlan Italy S.r.l., 33049 San Pietro al Natisone (UD), Italy
Date of arrival: 25 September 2008
Weight range at arrival: 150.3 to 180.0 grams
Acclimatisation period: At least 5 days
Veterinary health check: after arrival
Caging
No. of animals/cage: 3 during the study; up to 5 during acclimatisation
Housing: Polycarbonate cages measuring 42.5x26.6x18 cm (step 1 to 4) or 59x38.5x20 cm (during acclimatisation), with stainless steel mesh lid and floor.
Cage tray control: Daily inspected and changed as necessary (at least 3 times/week)
Water and diet
Water: drinking water supplied to each cage via a water bottle
Water supply: ad libitum
Diet: 4 RF 18 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy)
Diet supply: ad libitum throughout the study except for dosing procedure
Housing conditions (parameter set)
Room lighting: Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
Air changes: Approximately 15 to 25 air changes per hour
Temperature range: 22°C ± 2°C
Relative humidity range: 55% ± 15%
Actual conditions were monitored and recorded, and records retained. No relevant deviations occurred.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- Concentration : 30 and 200 mg/ml
- Details on oral exposure:
- Dosing
Frequency of treatment : Once only, on the day of dosing (Day 1).
Fasting procedure : Overnight prior to dosing (Day –1) up to 4 hours after dosing.
Dose calculation : Dose volume of 10 ml/kg of body weight for each animal.
Dosing method : By gavage, using a rubber catheter attached to a graded syringe. - Doses:
- Since information available suggested possible mortality occurring at the dose level of 2000 mg/kg, a first sub-group of 3 female animals was dosed at a level of 300 mg/kg (step 1). Mortality did not occur. A second subgroup, similarly composed, was then dosed at the same dose level (step 2). No mortality occurred. Consequently, a first subgroup of 3 females was dosed at 2000 mg/kg (step 3). Mortality did not occur. A second sub-group, similarly composed, was then dosed at the same dose level (step 4). No mortality occurred and no further doses were investigated since the objective of the study had been achieved.
- No. of animals per sex per dose:
- 3 female animals/subgroup
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: mortality and morbidity: twice daily; clinical signs: day of dosing (on dosing, approximately 0.5, 2 and 4h after dosing), daily thereafter (14 days); body weight: allocation (day-1), days 1,2,8 and 15.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in the female animals dosed at 300 mg/kg (steps 1 and 2).
No mortality was recorded in the female animals dosed at 2000 mg/kg (steps 3 and 4). - Clinical signs:
- other: At 300 mg/kg, reduced activity and piloerection were observed on the day of dosing. Recovery occurred by Day 2. In the first subgroup of 3 animals (step 3), piloerection, reduced activity and hunched posture were observed on the day of dosing. Piloerectio
- Gross pathology:
- No abnormalities were observed at necropsy examination performed at the end of the observation period on all the animals dosed at 300 mg/kg (steps 1 and 2) or 2000 mg/kg (steps 3 and 4).
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- These results indicate that the test item, KETOPROFEN/CFPPN, has a slight toxic effect on the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg body weight.
Mortality did not occur and some clinical signs, essentially reversible, were observed in the animals following dosing at 300 mg/kg or 2000 mg/kg, with a faster recovery period in the former case.
These results indicate that the test item, KETOPROFEN/CFPPN, has a slight toxic effect on the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg body weight.
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