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EC number: 925-425-7 | CAS number: -
- 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
VETYNAL EXTRA (LD50 > 2000 mg/Kg): Supporting study, Acute Oral Toxicity Study in Rats dated on 2002, performed at RCC Ltd, author G. Arceli
VETYVENAL (LD50 > 2000 mg/Kg): Key study, Acute Oral Toxicity Study in Rats dated 2002,performed at RCC Ltd author Dr. E. Rosner
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:
- May 17 - June 17 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- Name (as stated in the report): VETYVENAL
Batch: 285526
Expiration date: March 25, 2003 - Species:
- rat
- Strain:
- other: HanBrl: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 3 males and 3 females (Rat, HanBrl: Wist (SPF)) were used when treated respectively: 8 weeks and 10 weeks old. By unique cage number and corresponding color-coded spots on the tail. Under laboratory conditions, after health examination, only animals without any visible signs of illness were used for the study.
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- The animals received a single dose of the test article on a 2000 mg/kg body weight basis by oral gavage following fasting for 16.5 and 18.5 hours, but with free access to water. Food was provided again approximately 3 hours after dosing.
The application volume was 10 ml/kg body weight.
Rationale: Oral administration was used as this is one possible route of human exposure during manufacture, handling and use of the test article. - Doses:
- The dose formulations were made shortly before each dosing occasion. The concentration of the test item dosage was: 2000 mg/kg body weight (single dose). The test item was diluted in vehicule (PEG 300) at a concentration of 0.2 mg/l and administered at a volume dosage of 10 ml/kg.
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred during the study.
- Clinical signs:
- No clinical signs were observed during the study period.
- Body weight:
- The body weight of the animals was within the range commonly recorded for this strain and age.
- Other findings:
- No macroscopic findings were recorded at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of VETYVENAL after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occured.
LD50(rat): greather than 2000 mg/kg body weight. - Executive summary:
Two groups, each using three male or three female HanBrl: WIST (SPF) rats were treated with VETYVENAL at 2000 mg/kg by oral gavage. The test article was suspended in vehicle (polyethylene glycol PEG 300) at a concentration of 0.2 mg/l and administered at a volume of 10 ml/kg.
The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15.
Mortality/viability were recorded together with clinical signs at the same time intervals.
Body weights were recorded on day 1 prior to administration and on days 8 and 15.
All animals were necropsied and examined macroscopically.
No death occurred during the study.
No clinical signs were observed in the females during the course of the study.
The body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were recorded at necropsy.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- August 29 - September 11 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- Name (as stated in the report): VETYNAL Extra
Batch: 9000474504
Expiration date: June 15, 2004 - Species:
- rat
- Strain:
- other: HanBrl: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 3 males and 3 females (Rat, HanBrl: Wist (SPF)) were used when treated respectively: 9 weeks and 13 weeks old. Unique cage number and corresponding color-coded spots on the tail. The animals were marked immediately prior to treatment. Under laboratory conditions, after health examination, only animals without any visible signs of illness were used for the study.
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- The animals received a single dose of the test item by oral gavage administration at 2000 mg/kg body weight after being fasted for 17 and 18 hours (access to water was permitted). Food was provided again approximately 3 hours after dos-ing.
The application volume was 10 ml/kg body weight.
Rationale: Oral administration was considered to be an appropriate application method as it is a possible route of human exposure during manufacture, handling and use of the test item. - Doses:
- The dose formulations were made shortly before each dosing occasion. The concentration of the test item dosage was: 2000 mg/kg body weight (single dose). The test item was diluted in vehicule (PEG 300) at a concentration of 0.2 mg/l and administered at a volume dosage of 10 ml/kg.
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived until the end of the study period.
- Clinical signs:
- No clinical signs were observed in the females during the course of the study.
- Body weight:
- The body weight of the animals was within the range commonly recorded for this strain and age.
- Gross pathology:
- Slightly ruffled fur and hunched posture was observed in all male animals from 2 to 3 hours after administration.
- Other findings:
- No macroscopic findings were recorded at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of VETYNAL EXTRA after single oral administration to rats of both sexes, observed over a period of 14 days is:
LD50(rat): greather than 2000 mg/kg body weight. - Executive summary:
Three male and three female HanBrl: WIST (SPF) rats were treated with VETYNAL EXTRA by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 mg/l and administered at a volume dosage of 10 ml/kg.
The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximatively 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded twice daily during test days 1-15. Body weights were recorded on day 1 (prior administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study period.
Slightly ruffled fur and hunched posture was observed in all male animals from 2 to 3 hours after administration. No clinical signs were observed in the females during the course of the study.
The body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were recorded at necropsy.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The median lethal dose of VETYVENAL after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occured.
LD50(rat): greather than 2000 mg/kg body weight, according to the CLP Regulation 1272/2008/EC & adaptation 286/2011/EC the cirteria for classification are not met.
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