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EC number: 605-420-3 | CAS number: 165950-84-5
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 09, 2012 - June 13, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nohsan, Notification No. 8147, April 2011; including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- (6S)-6-(propylamino)-5,6,7,8-tetrahydronaphthalen-1-ol hydrobromide
- EC Number:
- 605-420-3
- Cas Number:
- 165950-84-5
- Molecular formula:
- C13H20BrNO
- IUPAC Name:
- (6S)-6-(propylamino)-5,6,7,8-tetrahydronaphthalen-1-ol hydrobromide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: White powder
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI (Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Young adult animals (approx. 8-9 weeks old)
- Weight at study initiation: 159-160 g (1st group), 165-179 g (2nd group) and 146-151 g (3rd group)
- Fasting period before study: Animals were deprived of food overnight prior to dosing
- Housing: Group housing of 3 animals per cage in labeled Makrolon cages with cage-enrichment and bedding material
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany)
- Water: Free access to tap water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 18 – 24
- Humidity (%): 40 - 70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Variations to these conditions occurred (i.e. maximum relative humidity of 71 or 72% on a single day, respectively). Based on the laboratory’s extensive experience with variations in these parameters and absence of any clinical signs among the animals that could be associated to these variations, these were considered to have no effect on the outcome of the study.
IN-LIFE DATES: From: May 22, 2012 to June 13, 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Remarks:
- (specific gravity: 1.036)
- Details on oral exposure:
- GAVAGE METHOD: plastic feeding tubes
Frequency: single dosage, on day 1
VEHICLE
- The vehicle was selected based on trial formulations performed at WIL Research Europe and on test substance data supplied by the sponsor
DOSE VOLUME APPLIED
2000 mg/kg (10 mL/kg) body weight
300 mg/kg (10 mL/kg) body weight
DOSAGE PREPARATION
The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle. No correction was made for purity of the test substance. - Doses:
- - 2000 mg/kg body weight (1 group)
- 300 mg/kg body weight (2 groups) - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg bw. Thereafter, a second and third group were tested at 300 mg/kg bw. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.
Animals were deprived of food until 3-4 hours after administration of the test substance.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily. Animals showing pain, distress or discomfort, which was considered not transient in nature or was likely to become more severe, were sacrificed for humane reasons based on OECD guidance document on humane endpoints (ENV/JM/MONO/ 2000/7). The time of death was recorded as precisely as possible.
Body weights: days 1 (pre-administration), 8 and 15 and at death (if found dead or sacrificed after day 1).
Clinical signs: At periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15.
- Necropsy of survivors performed: All animals were subjected to necropsy and descriptions of all internal macroscopic abnormalities recorded.
- Other examinations performed: none. - Statistics:
- No statistical analysis was performed (the method used is not intended to allow the calculation of a precise LD50 value).
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - 2000 mg/kg bw: one female was found dead at approximately 2 hours after dosing on day 1 and one female was sacrificed for ethical reasons on day 2.
- 300 mg/kg bw (both groups): no mortality occurred - Clinical signs:
- other: - 2000 mg/kg bw: -- The surviving animal showed lethargy, restless behavior, hunched posture, uncoordinated movements on days 1-4. -- The animal, which was sacrificed on day 2, showed lethargy, tremor of the head, flat and hunched posture, uncoordinated m
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Any other information on results incl. tables
According to the OECD 423 test guideline the LD50 cut-off value was considered to be 1000 mg/kg body weight.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- In an acute oral toxicity study with the substance in rats, performed according to OECD 423 and GLP principles, an LD50 of > 300 - < 2000 mg/kg bw was determined. Based on this result, the substance is classified for acute toxicity by the oral route (Category 4) with Harmful if swallowed (H302).
- Executive summary:
The acute oral toxicity of the substance was determined in accordance with OECD 423 (2001) and according to GLP principles. The substance was administered by oral gavage to three subsequent groups of three female Wistar rats at 2000 (1 group) and 300 mg/kg body weight (2 groups). At 2000 mg/kg bw, one female was found dead at approx. 2 hours after dosing and one female was sacrificed for ethical reasons on day 2. At 300 mg/kg bw, no mortality occurred. At 2000 mg/kg bw, no clinical signs were scored in the animal which was found dead within 2 hours after dosing. The animal, which was sacrificed on day 2, showed lethargy, tremor of the head, flat and hunched posture, uncoordinated movements, abnormal gait of hind legs, rales, shallow respiration, gasping, piloerection, chromodacryorrhoea, lean appearance and ptosis on days 1 and/or 2. The surviving animal showed lethargy, restless behavior, hunched posture, uncoordinated movements on days 1-4. At 300 mg/kg bw, the animals showed hunched posture, uncoordinated movements and/or restless behaviour on days 1 and/or 2. No abnormalities were found at macroscopic post mortem examination of the animals. The acute oral toxicity (LD50) was determined to be > 300 - < 2000 mg/kg bw. Based on this result, the substance is classified for acute toxicity by the oral route (Category 4) with Harmful if swallowed (H302). According to the OECD 423 test guideline the LD50 cut-off value was considered to be 1000 mg/kg body weight.
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.
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