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EC number: 280-479-2 | CAS number: 83547-95-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
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:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 1981
- Deviations:
- not specified
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide
- EC Number:
- 280-479-2
- EC Name:
- 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide
- Cas Number:
- 83547-95-9
- Molecular formula:
- C30H57O7PS3
- IUPAC Name:
- 2-ethylhexyl 2-{[bis({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)phosphoryl]sulfanyl}acetate
- Test material form:
- liquid
- Details on test material:
- - Other: Trade name D 16-051
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL (as stated in study report): TK 12184
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / Batch No. Mixt. 4/5/6
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Production, CIBA-GEIGY LTD., 4332 Stein/Switzerland
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: males - 171 - 174; females - 164 - 170
- Housing: individually in Macrolon cages type 3 with standardised granulated soft wood bedding
- Diet (e.g. ad libitum): Pelleted, certified Standard diet Nafag No. 890 Tox, ad libitum except during urine collection.
- Water (e.g. ad libitum): ad libitum except during urine collection
- Acclimation period: one week
DETAILS OF FOOD AND WATER QUALITY: All batches of diet were assayed for composition and contaminant level by the manufacturer. Water
was drinking quality according to the specifications of the "Schweizerisches
Lebensmittelbuch".
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 deg C
- Humidity (%): 55 + 10 %
- Air changes (per hr): 15 - 17
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5%
- Details on oral exposure:
- Dosing solutions were freshly prepared every day iramediately prior to the dosing of the animals and administered within 2 hours.
Dosage volume: 10 mL/kg - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 d
- Frequency of treatment:
- Once daily, seven days per week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 30 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Animals were assigned to the different groups by means of random numbers generated by computer.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes, mortality
- Time schedule: daily (a.m. and p.m. on working days)
DETAILED CLINICAL OBSERVATIONS: Yes, symptoms
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION: Yes, weekly
FOOD EFFICIENCY: Yes, weekly
WATER CONSUMPTION: Yes
- Time schedule for examinations: days 15 - 18 and days 22 - 24
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: beginning and end of treatment period
- Dose groups that were examined: control and high dose groups
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at end of treatment period
- Anaesthetic used for blood collection: Yes, ether
- Animals fasted: Yes, about 20 hours
- How many animals: 5 per sex per group
- Parameters examined: RBC count, hemoglobin, platelet count, leucocyte count, total count.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at end of treatment period
- Animals fasted: Yes, about 20 hours
- How many animals: 5 per sex per group
- Parameters examined: glucose, urea, total protein, GOT, GPT, AP.
URINALYSIS: Yes
- Time schedule for collection of urine: at end of treatment period
- Metabolism cages used for collection of urine: Yes, overnight
- Animals fasted: Yes, food and water withheld
- Parameters examined: pH, protein, glucose, urobilinogen, sediment.
OTHER EXAMINATIONS: Hearing tests were conducted on control and high dose groups at the end of the treatment period.
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, all animals were subjected to detailed autopsy.
ORGAN WEIGHTS: liver, adrenals, brain, spleen, thymus, heart, kidneys and gonads.
HISTOPATHOLOGY: A standard set of 36 organs and tissues as well as any grossly abnormal tissues were preserved in 10 % neutral formalin for possible examination. - Statistics:
- For each time point and parameter a uni-variate statistical analysis was conducted. Due to the routine manner of the analysis system parameter free methods were applied. Each treated group was compared to the control group in respect of dispersion and displacement. In addition a trend test was applied considering all groups.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- The mean water consumption in male and female groups 4 (300 mg/kg bw.) tended to increase towards the end of the treatment period.
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A slight decrease of the number of leucocytes in the females of the 100 and 300 mg/kg/day groups.
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Statistical analysis of organ weights and organ weight ratios showed a statistically significant decrease in liver weights of male group 4 (300 mg/kg bw.) and a similar trend in females.
A few inconsistent but statistically significant intergroup variations in organ weights, organ to body weight and organ to brain weight ratios were found. Although statistically significant these differences were not dose related and are attributed to spontaneous variation rather than to the treatment. - Gross pathological findings:
- not specified
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed
- Dose descriptor:
- LOEL
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under these test conditions, the oral administration of TK 12 184 to rats by gavage, at dose levels of 30, 100 and 300 mg/kg bw/day did not result in mortality. No adverse effects were seen on clinical symptoms, body weight gain, food consumption, ophthamology, hearing, or on hematology, blood chemistry or urinalysis parameters. Mean water consumption tended to increase in male and female animals receiving 300 mg/kg/day toward the end of the treatment period. Statistically significantly lower liver weights were seen in males and females of the 300 mg/kg/day dose group. The ‘No Observed Effect Level’ (NOEL) for systemic toxicity was therefore considered to be 100 mg/kg bw/day.
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