Registration Dossier
Registration Dossier
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EC number: 280-960-7 | CAS number: 83817-60-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 - 25 Aug 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 Dec 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May 2008
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OGYÉI, Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet, Budapest, Hungary
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Ethyl 9-oxo-9H-thioxanthene-2-carboxylate
- EC Number:
- 280-960-7
- EC Name:
- Ethyl 9-oxo-9H-thioxanthene-2-carboxylate
- Cas Number:
- 83817-60-1
- Molecular formula:
- C16H12O3S
- IUPAC Name:
- ethyl 9-oxo-9H-thioxanthene-2-carboxylate
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: recommended at temperatures > 25 °C
FORM AS APPLIED IN THE TEST (if different from that of starting material): liquid
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TOXI COOP ZRT, Budapest, Hungary
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 11 weeks
- Weight at study initiation: 238 g, 221 - 224 g (at second step)
- Fasting period before study: The day before treatment animals were fasted.
- Housing: 5 animals of the same sex per cage in Type II polypropylene/polycarbonat cages
- Diet: ssniff® SM R/M-Z+H complete diet for rats and mice (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 27 days (first step), 28 days (second step)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): >10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 09 Aug To: 24 Aug (first step group)/ 25 Aug (second step group)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- 1% in water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no.: Y73372811
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Starting dose was selected on the basis of the available information about the test item. A stepwise procedure was applied, with the use of 5000 mg/kg bw as the starting dose in one female rat. The first animal survived and thus, as recommended in Annex 3 of the OECD TG 423, 2 further female rats were dosed similarly. - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 3 females
- Control animals:
- no
- Remarks:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h after the treatment and once each day for 14 days thereafter. The body weights were recorded on day 0 (just before the treatment), on day 7 and on day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Tissues and organs of the cranial, thoracic and abdominal cavities were examined for gross abnormalities.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: No clinical signs were observed in any animal throughout the 14-day post-treatment period.
- Gross pathology:
- No treatment-related gross pathological changes were found. In fact, severe hydrometra was detected in 1/3 animals and moderate hydrometra was observed in another one animal, the finding however is considered a physiological one rather than due to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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