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EC number: 617-182-8 | CAS number: 809282-20-0
- 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:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 17th, 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- Directive no 2004/73/EC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Benzenemethanol, α-[(1S)-2-(dimethylamino)-1-methylethyl]-α-ethyl-3-methoxy-, (αR)-
- Cas Number:
- 809282-20-0
- Molecular formula:
- C15H25NO2
- IUPAC Name:
- Benzenemethanol, α-[(1S)-2-(dimethylamino)-1-methylethyl]-α-ethyl-3-methoxy-, (αR)-
- Test material form:
- solid: crystalline
- Details on test material:
- white crystalline solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Fifteen Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle - France), were used after an acclimatisation period of at least five days.
At the beginning of the study, the animals of the treated group weighed between 181 and 202 g and were 8 weeks old.
Housing:
Three healthy female rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in a conventional air conditioned animal husbandry; the environmental conditions were:
- Temperature: between 19˚C and 23 ˚C
- Relative humidity: between 40% and 68%
- Lighting time: 12 hours daily
Food and drink:
Drinking water (tap-water from public distribution system) and foodstuffs were supplied freely except during treatment period for the food.
Microbiological and chemical analyses of the water were carried out once every six months by the Institut Européen de l’Environnement de Bordeaux (I.E.E.B.).
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- The animals of groups 2 and 3, received respectively an effective dose of 2000 mg/kg bw and 300 mg/kg bw of the test item T2955, diluted in olive oil and administered by force-feeding under a volume of 10 ml/kg bw using a suitable syringe graduated fitted with an oesophageal metal canula.
The animals of group 1, received, according to the same experimental conditions, the control item (distilled water) under a volume of 2 ml/kg bw. - Doses:
- group 1: 0 mg/kg bw (control group, distilled water)
group 2: 2000 mg/kg bw
group 3: 300 mg/kg bw - No. of animals per sex per dose:
- group 1: 6 female rats
group 2: 3 female rats
group 3: 6 female rats - Control animals:
- yes
- Details on study design:
- Daily examination:
Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test item.
This examination focuses particularly on a list of symptoms, recorded as ‘present’ or ‘absent’ on the observation sheet.
These observations were compared to control data.
Observations and a mortality report were then carried out every day for 14 days.
Periodical examinations:
The animals were weighed on day D0 (just before administering the test item), then on D2, D7, and D14.
Weight changes were calculated and recorded.
Examination at the end of the test:
On D14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic observations were entered on individual autopsy sheets.
Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 500 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD100
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- <= 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- It was noted the death of 3 treated rats at 2000 mg/kg bw, 10 minutes after the test item administration. The mortalities were preceded by convulsions, during the first minutes of the test.
No mortality occurred in the animals treated with 300 mg/kg bw. - Clinical signs:
- other: The mortalities were preceded by convulsions, during the first minutes of the test. It was registered in the animals treated at 300 mg/kg bw, from thirty minutes after the test item administration, a decrease of the spontaneous activity (6/6) associated w
- Gross pathology:
- The macroscopical examination of the animals treated at 2000 mg/kg bw which died during the test did not reveal treatment-related changes.
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 cut-off of the test item T2955 is 500 mg/kg bw by oral route in the rat.
- Executive summary:
Summary:
The test item T2955 was administered in a first step to a group of 3 female Sprague Dawley rats at the single dose of 2000 mg/kg bw and in the second step to a group of 6 female Sprague Dawley rats at the single dose of 300 mg/kg bw. The experimental protocol was established according to the official method as defined in the OECD guideline no 423 dated December 17th, 2001 and the test method B.1 tris of the Directive no 2004/73/EC.
It was noted the death of 3 treated rats at 2000 mg/kg bw, 10 minutes after the test item administration. The mortalities were preceded by convulsions, during the first minutes of the test.
No mortality occurred in the animals treated with 300 mg/kg bw.
It was registered in the animals treated at 300 mg/kg bw, from thirty minutes after the test item administration, a decrease of the spontaneous activity (6/6) associated with bradypnea (5/6), tremors (1/6), mydrias (4/6), and a decrease of the righting reflex (3/6). The animals recovered a normal activity the 2ndday of the test.
The body weight evolution of the animals treated at 300 mg/kg bw remained normal throughout the study, similar between treated and control animals.
The macroscopical examination of the animals treated at 2000 mg/kg bw which died during the test did not reveal treatment-related changes.
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
In conclusion, the LD50 cut-off of the test item T2955 is 500 mg/kg bw by oral route in the rat.
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