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Diss Factsheets
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EC number: 274-641-1 | CAS number: 70516-41-5
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 March 1982 - 15 April 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study cannot be considered reliable without restrictions, as it does not include a formal claim of GLP compliance, nor was it conducted in accordance with official test guidelines (it should be noted that such guidelines, and official GLP guidelines were not available at the time when the study was conducted). The study does contain a statement of Quality Assurance, and is generally well documented; in addition, the methodology employed is largely consistent with modern methodology for the assessment of acute oral toxicity, and on this basis the study is considered reliable (with restrictions).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- not applicable
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- S-205
- IUPAC Name:
- S-205
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): S-205, 2-anilino-3-methyl-6-[(N-ethyl-N-iso-pentyl)amino]-spiro(phthalide-3,9-xanthene)
- Lot/batch No.: LS 8
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 101 - 133 g
- Fasting period before study: Yes (overnight before dosing, and for approximately 4 hours after dosing).
- Housing: Housed by group in metal cages with wire mesh floors
- Diet (e.g. ad libitum): Ad libitum (except prior to dosing, as described above)
- Acclimation period: 4 or 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5 ± 1.5°C
- Humidity (%):55 - 67%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light per 24 hours period.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% Aqueous Methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 40% (w/v)
- Amount of vehicle (if gavage): 40 mL/kg bodyweight. - Doses:
- 16.0 g/kg
A concurrent control group was dosed with untreated 1% Methylcellulose at 40 mL/kg bodyweight. - No. of animals per sex per dose:
- Preliminary study; two males and two females.
Main study; five males and five females. - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days (6 days during the preliminary study).
- Frequency of observations and weighing: Animals were observed shortly after dosing, then at frequent intervals for the remainder of day 1. On subsequent days animals were observed at least twice daily. Individual bodyweights were recorded on days 1, 8, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.
Results and discussion
- Preliminary study:
- No deaths were seen during the preliminary study; the main study was subsequently run using the same dose level (16 g/kg bodyweight)
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 16 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities were observed in any of the animals treated with S-205 in either the preliminary or main studies.
- Clinical signs:
- other: Signs of reaction to treatment (Table 3) observed shortly after dosing in all treated rats included pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling).
- Gross pathology:
- Autopsy findings were within normal limits.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of S-205 was found to be greater than 16.0 g/kg bodyweight.
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