Registration Dossier
Registration Dossier
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EC number: 407-430-1 | CAS number: 3741-80-8 CP22595; SANTOCURE TBS1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to US EPA and EU protocol. Minor deviations from animal housing and care AAALAC standards were reported, but were considered to have had no effect on the outcome of this study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA-TSCA 40 CFR Part 798 section 798.2650
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC method No. L 251/94
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-(1,1-dimethylethyl)bis(2-benzothiazolesulfen)amide
- EC Number:
- 407-430-1
- EC Name:
- N-(1,1-dimethylethyl)bis(2-benzothiazolesulfen)amide
- Cas Number:
- 3741-80-8
- Molecular formula:
- C18H17N3S4
- IUPAC Name:
- bis(1,3-benzothiazol-2-ylsulfanyl)(tert-butyl)amine
- Details on test material:
- - Name of test material (as cited in study report): CP-22595
- Physical state: off white powder
- Analytical purity: 89.0 - 93.3%
- Purity test date: 21 December 1989 and 06 April 1990.
- Lot/batch No.: 4064285
- Stability under test conditions: confirmed by HPLC experiment
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALSCharles River Laboratories Inc., Portage, Michigan
- Age at study initiation: young adult
- Weight at study initiation: ca 280 grams (males), ca. 187 grams (females)
- Housing: individually housed in suspended stainless steel cages in an environment-controlled room
- Diet (e.g. ad libitum): Agway Prolab Rodent Feed, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days
- Animal identification: metal ear tags and cage cards
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61-70°F (= ca. 16-21°C)
- Humidity (%): 40-60%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Animals were fastened overnight prior to dose administration.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 250 mg/mL
- Amount of vehicle (if gavage): 20 mL / kg bw
- Justification for choice of vehicle: not specified
- Lot/batch no. (if required): not specified
- Purity: not specified - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: daily, weighing: weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
- Preliminary study:
- Range-finding study: Male and female rats were administered the test substance by a single oral dose at the following levels:
500, 1000, 2000, 3000 and 5000 mg/kg bw.
Following dosing, the animals were observed for mortality for eight consecutive days. No deaths occurred.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during this study.
- Clinical signs:
- other: The most notable clinical signs consisted of transient incidences of urine/fecal stains, soft stools and reddish colored urine.
- Gross pathology:
- Internal obervations at necropsy were limited to reddened adrenal glands in one animal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, the acute oral LD50 of the test substance was determined to be greater than 5000 mg/kg bw in the rat.
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