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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
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.
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