2,2'-thiodiethanethiol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 May 2012 - 13 Jun 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

2008

Deviations:

yes

Remarks:

the study could have been terminated after 100% mortality in the 300 mg/kg group

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

yes

Remarks:

the study could have been terminated after 100% mortality in the 300 mg/kg group

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-thiodiethanethiol

EC Number:

222-671-0

EC Name:

2,2'-thiodiethanethiol

Cas Number:

3570-55-6

Molecular formula:

C4H10S3

IUPAC Name:

2,2'-sulfanediyldiethanethiol

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Crl: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation: 161 - 185 g
- Fasting period before study: ca. 16 h
- Housing: in groups of 3 animals in MAKROLON cages on granulated textured wood
- Diet: Commercial diet, ssniff® R/M-H V1534, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 12-18
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2012-05-21 To: 2012-06-13

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.8% aqueous methylhydroxypropylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5, 30, 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

Doses:

50, 300, 2000 mg/kg bw

No. of animals per sex per dose:

3-6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed
before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after
administration. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study and at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 50 - < 300 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

200 mg/kg bw

Based on:

test mat.

Mortality:

50 mg/kg bw: 0/6
300 mg/kg bw: 3/3 (death within 3 h post dose)
2000 mg/kg bw: 3/3 (death within 3 h post dose)

Clinical signs:

other: 50 mg/kg bw: revealed slightly reduced motility, slight ataxia, slight tremor, slightly reduced muscle tone and slight dyspnoea 300 mg/kg bw: slightly to moderately reduced motility, slight to moderate ataxia, slight to moderate tremor, slightly reduced

Gross pathology:

no pathological findings

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The LD50 value was ranked between 50 and 300 mg/kg bw. LD50-cut-off value according to OECD TG 423 was 200 mg/kg bw. DMDS should be classified as Acute Tox 3 - H301: Toxic if swallowed.