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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:
2016
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

Constituent 1
Chemical structure
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
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