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EC number: 603-080-0 | CAS number: 125572-93-2
- 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:
- 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: FDA’s Department of Health and Human Services Revised Guidance for Single Dose Acute Toxicity Testing for Pharmaceuticals (Federal Register, Volume 61, No. 166, issued 26 Aug 1996; 61 FR 43934)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- dd 15.4.2005
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1-Naphthalenol, 5,6,7,8-tetrahydro-6-[propyl[2-(2-thienyl)ethyl]amino]-, (6S)-
- EC Number:
- 619-458-3
- Cas Number:
- 99755-59-6
- IUPAC Name:
- 1-Naphthalenol, 5,6,7,8-tetrahydro-6-[propyl[2-(2-thienyl)ethyl]amino]-, (6S)-
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: Off white powder
- Storage conditions: in tight containers, temperature not above 25°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD® / Crl: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 49 days (males), 59 days (females)
- Weight at study initiation: 245-272 g (males), 196-229 g (females)
- Fasting period before study: yes, feeding was discontinued approx. 16 hours before administration
- Housing: During the 14-day observation period the animals were kept in groups of 3 animals per sex in MAKROLON cages (type III)
- Diet: Ssniff® R/M-H V1530, ad libitum except approx. 16 hours before administration
- Water: tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 (maximum range)
- Humidity (%): 55 ± 15 (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 13 February 2006 To: 01 March 2006
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: hydroxypropylmethylcellulose gel
- Remarks:
- (0.8%)
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 20 mL/kg bw
- Batch no.: Methocel, batch no. 0403A093, Synopharm GmbH, D-22885 Barsbüttel
DOSAGE PREPARATION: The aqueous solutions were prepared freshly on the day of administration. - Doses:
- Dose range finding study: 50, 100, 200, 300, 500 and 1000 mg/kg bw
Main study: 215, 464, 1000, 1470 mg/kg bw - No. of animals per sex per dose:
- 3 (main study)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration and at least daily thereafter.
- Frequency of weighing: before administration of the test item and thereafter in weekly intervals up to the end of the study and at death.
- Necropsy of survivors performed: yes - Statistics:
- The approximate LD50 was calculated according to FINNEY by regression analysis. The mortality rates at 24 hours and 14 days were used.
Results and discussion
- Preliminary study:
- No signs of toxicity were observed up to and including the dose level of 200 mg/kg bw. Dose levels of 300 and 500 mg/kg bw caused slight signs of toxicity, the dose level of 1000 mg/kg bw caused severe signs of toxicity and death.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Remarks:
- 14 days
- Effect level:
- ca. 1 231 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was seen at 215 and 464 mg/kg bw. At 1000 mg/kg bw one male and one female died, both within 30 minutes after exposure. At 1470 mg/kg bw one male and one female died within 15 minutes after exposure, one additional male died within 24 hours and one additional female died in the second week after exposure (day 9).
- Clinical signs:
- other: Starting at a dose level of 464 mg/kg bw slightly reduced motility, slight ataxia, slight dyspnea and stereotypy in all 3 of 3 male and 3 of 3 female rats were noted. At 1000 mg/kg bw, in addition, slight tremor was observed in all 3 of 3 male and 3 of 3
- Gross pathology:
- No macroscopical changes were noted.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the outcome of an acute oral toxicity test with male and female rats, performed according to EU guideline and GLP principles, the LD50 of SPM 962 was found to be appr. 1231 mg/kg bw.
- Executive summary:
An acute oral toxicity test was performed with SPM 962, according to EU guideline and GLP principles. Rats (3/sex/dose) were exposed to 215, 464, 1000 or 1470 mg/kg bw. At the dose level of 1000 mg/kg bw, one male and one female died within 30 minutes. At 1470 mg/kg bw, one male and one female died within 15 minutes, another male within one day and a second females within 9 days after administration. Clinical signs noted at 464 mg/kg bw and above included reduced motility, ataxia, tremor, dyspnea, clonic convulsions, myosis and stereotypy.
Based on these results, the LD50 of SPM 962 was found to be appr. 1231 mg/kg bw. As a result, the test substance is classified cat. 4 for acute oral toxicity according to Regulation (EC) No 1272/2008.
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