Ethylene di(S-thioacetate)

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:

guideline study

Justification for type of information:

The acute toxicity study with the substance will be used to fill data gaps for acute toxicity endpoint. Furthermore, this information will strengthen the planned read-across approach by providing information about acute toxic effects of the substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethylene di(S-thioacetate)

EC Number:

204-653-4

EC Name:

Ethylene di(S-thioacetate)

Cas Number:

123-81-9

Molecular formula:

C6H10O4S2

IUPAC Name:

ethane-1,2-diyl bis(sulfanylacetate)

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

ANIMALS
- Source: ENVIGO Ctra. St. Miquel del Fai, Km. 3 08182 - Sant Feliu de Codines Barcelona – Spain
- Age: 7 at arrival, 8-12 weeks on administrations
- Acclimatization: 5 days
- weight: approx. 180g
- Housing: 6 (before distribution) and 3 (after distribution)
- Diet: ad libitum Global diet 2914C; Envigo RMS Spain
- Water: ad libitum tap water

CONDITIONS:
- Light cycle: 12:12 – 07.00h to 19.00h CET
- Temperature: 22 ± 3 ºC
- Relative humidity: 30 – 70%

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

ethanol

Remarks:

purity: 96%

Details on oral exposure:

Animals will be fasted overnight before administration and approx. 3-4h afterwards

Doses:

300, 50mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Clinical observations:
Approx. 30 minutes, 2h, and 4h post-administration daily thereafter for
14 days.

Body weight:
Once on acclimatisation week; On first day before administration, weekly thereafter and prior to sacrifice

Terminal investigation:
Animals will be sacrificed 14 days after administration (dose step 1; study day 15) and a gross necropsy will
be performed on all animals, including early deaths, if possible.
Animals will be will be euthanized in a CO2 atmosphere and subjected to a gross necropsy consisting in the
examination of the abdominal and thoracic cavities and contents. Any organ with gross lesions will be collected
and preserved in fixation medium (neutral-buffered 4 % formaldehyde) for histological evaluation, if considered
relevant (at additional costs). The organs will be temporarily stored for up to one month and will be discarded
if no microscopic examination is ordered by the sponsor.
Animals dying during the study or sacrificed for animal welfare reasons will be also subjected to a gross
necropsy.

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 50 - <= 300 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Mortality:

In this acute oral toxicity study with the test item Thiocure it was seen that at doses of 300 mg/kg the test item caused immobility, lethargy, marked piloerection and respiratory difficulties, so for animal welfare decision animals were sacrificed. Therefore the mortality rate for 300mg/kg bw was determined to be 100%

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The LD50 is between 50 and 300 mg/kg in rat after a single oral administration in both sexes.

Executive summary:

The test substance Thiocure 120 was tested in an acute oral toxicity study using 3 female rats per dose group, at doses of 300mg/kg bw and 50 mg/kg bw. It was seen that at doses of 300 mg/kg the test item caused immobility, lethargy, marked piloerection and respiratory difficulties, so for animal welfare decision animals were sacrificed. At doses of 50 mg/kg bw rats showed no clinical signs and no mortality was observed.