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Diss Factsheets
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EC number: 603-392-7 | CAS number: 130198-05-9
- 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
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Endpoint summary
Administrative data
Description of key information
The acute toxic class method was started at the dose level of 2000 mg/kg in female animals (n=3). All animals died, so the test was continued at the dose level of 200 mg/kg in female animals (n=3). No mortality occurred, so the test was repeated at the same dose level in male animals (n=3). No male animals died therefore the study was terminated after the 14 day observation period.
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to recommended guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- 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:
- Husbandry
Animal health: Only animals in acceptable health condition were used for the test. It was certified by the veterinarian.
Number of animal room: 243/al
Housing: 3 animals I cage
Cage type: Ill. type polypropylene/polycarbonate
Bedding: laboratory bedding
Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30-70%
Water Supply
The animals received tap water as for human consumption, ad libitum, from 500 ml bottle. - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- The acute toxic class method was started at the dose level of 2000 mg/kg in female animals (n=3).
The test was continued at the dose level of 200 mg/kg in female animals (n=3) and then the test was repeated at the same dose level in male animals (n=3). - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Statistics:
- No statistical analysis was performed.
- Preliminary study:
- The acute toxic class method was started at the dose level of 2000 mg/kg in female animals (n=3): all animals died.
- Sex:
- female
- Dose descriptor:
- LD100
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- ca. 200 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- ca. 200 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All treated animals died after the treatment at the dose level of 2000 mg/kg. Death of animals occurred 4 hours, 10 minutes and 62 minutes after the application, respectively. Decreased activity, tremor, convulsions, ventral position and severe dyspnoea were observed immediately before the death.
- Clinical signs:
- other: In dose group of 2000 mg/kg the following clinical symptoms were observed: decreased activity (3/3), tremor (2/3) on the head, convulsions (2/3) on the upper part of the body, ventral position (2/3), squatting position (3/3), piloerection (2/3), dyspnoea
- Gross pathology:
- Dead animals
In the female dose group of 2000 mg/kg, point-like haemorrhages (No.: 4697,4720) and reddish mottled colour (No.:4726) were observed in the lungs. The liver was dark red in animal No.: 4720 and congestive in another one (No.:4726). In animal No.: 4720 hyperaemic (reddish) mucous membrane was found in the stomach and the wall of the intestines was edematous. This lately alteration was noticed in animal No.: 4726, too.
Surviving animals
In the male dose group of 200 mg/kg, pulmonary emphysema (No.: 4602,4618) and pinprick-sized (No.: 4599) haemorrhages were found in the lungs. In the female dose group of 200 mg/kg, pulmonary emphysema (No.: 4692,4754) and pinprick-sized haemorrhages (No.: 4740) were detected in the lungs. Besides, pale liver (No.: 4754) and a slight hydrometra (No.: 4740) occurred in this group.
In summary, macroscopic alterations related to the toxic effect of the test item were not found either in the dead or in the surviving animals. - Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 value of the test item Venlafaxin 2nd Intermediate was estimated between 200 mg/kg and 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
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
The key study shows that (i) LD100 is equal to or lower than 2000 mg/kg while (ii) LD0 is equal to or higher than 200 mg/kg: therefore, the LD50 value is included in this range. At 200 mg/kg female animals were symptom-free and male rats showed mild symptoms which disappear the next day. Moreover, venlafaxine hydrochloride, API that is structural analogue of the test material from which it is synthetized, has a LD50 value equal to 336 mg/kg.
According to CLP Regulation (1272/2008) the cut-off value between the hazard categories 3 and 4 for acute oral toxicity is lined up at 300 mg/kg. Even if a LD50 value was not clearly established for VP*HCl, considering the lack of relevant symptoms at the lower dose (200 mg/kg) and the LD50 value of venlafaxine hydrochloride greater than 300 mg/kg, VP*HCl is classified as Acute Tox 4 in accordance with CLP Regulation.Justification for selection of acute toxicity – oral endpoint
The effect level is considered higher than 300 mg/kg bw.
Justification for classification or non-classification
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should be classified for oral acute toxicity as Xn; R22 and Acute Tox 4 H302.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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