Diethyl sulphide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1993-11-15 to 1994-04-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed according to a OECD guideline and follows GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

limit test at 5000 mg/kg bw

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl ethyl sulphide (CAS # 624-89-5)

IUPAC Name:

Methyl ethyl sulphide (CAS # 624-89-5)

Details on test material:

- Name of test material (as cited in study report): methyl ethyl sulfide
- Molecular formula (if other than submission substance): C3H8S
- Molecular weight (if other than submission substance): 76.16 g
- Smiles notation (if other than submission substance): C(SC)C
- InChl (if other than submission substance): InChI=1/C3H8S/c1-3-4-2/h3H2,1-2H3
- Substance type: pure active substance
- Physical state: clear colorless liquid
- Stability under test conditions: data not available
- Storage condition of test material: room temperature, protected from light

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc., Portage, Michigan
- Age at study initiation: young adults
- Weight at study initiation: from 248 to 288 g for males and from 253 to 264 g for females (on day -1)
- Fasting period before study: yes (overnight)
- Housing: individually in stainless steel cages
- Diet: Purina certified Rodent chow #5002 ad libitum
- Water (e.g. ad libitum): municipal tap water treated by reverse osmosis or deionization, ad libitum
- Acclimation period: for a minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature: 62 to 72 °F (# 16.7 to 22.2°C)
- Humidity: 40 to 58%
- Air changes: 10 to 12 air changes per hour
- Photoperiod: 12 hrs dark / 12 rs light


IN-LIFE DATES: From 15-DEC-1993 to 29-DEC-1993

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 6 mL/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> clinical signs: 2 times on study day 0, and daily thereafter
> body weight: prior to fasting (day -1), prior to dosing on day 0, for all surviving animals on day 7 and 14, or at the time for death
- Necropsy of survivors performed: yes

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

One male rat died on day 1. All other animals survived up to the end of the study

Clinical signs:

other: The most notable clinical abnormalities observed during the study included salivation which was noted in 8/10 animals on study day 0 only, piloerection noted in 8/10 animals during the study day 0 to 2 interval, wobbly gait noted in all test animals on st

Gross pathology:

Gross internal findings noted at necropsy for the animal that died included clear yellow-red fluid contents in the urinary bladder, light green staining of glandular mucosa in the stomach and greenish-red mucoid contents in the entire tract of the small intestine. No gross internal findings were observed at necropsy on study day 14 for the surviving animals.

Any other information on results incl. tables

Table 1: Number of animals dead and with evident toxicity and time range within which mortality occurred

 

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (day)	Number with evident toxicity (#/total)
	Male	Female	Combined		Male	Female	Combined
5000	1/5	0/5	1/10	Day 1	5/5	5/5	10/10

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of Methyl Ethyl Sulphide was estimated to be greater than 5000 mg/kg in the rat.

Executive summary:

In an acute oral toxicity study (similar to OECD testing guideline 401 and according to GLP), groups of fasted, young adults Sprague-Dawley rats (5/sex) were given a single oral dose of undiluted methyl ethyl sulphide by gavage at dose of 5000 mg/kg bw (limit test) and observed for 14 days.

 

One male rat died on day 1. All other animals survived up to the end of the study. Clinical signs were observed in all animals: salivation, piloerection, wobbly gait, decreased activity, lacrimation, eyelids partially closed, transient incidences of urine stain, transient incidences of rales, rough haircoat, decreased/no defecation, dark material around the facial area, low food consumption. Gross internal findings noted at necropsy for the animal that died included clear yellow-red fluid contents in the urinary bladder, light green staining of glandular mucosa in the stomach and greenish-red mucoid contents in the entire tract of the small intestine. No gross internal findings were observed at necropsy on study day 14 for the surviving animals. The oral LD₅₀ (combined males/females) was > 5000 mg/kg bw.

 

This study received a Klimisch score of 1 and is classified as reliable with restriction because the study was performed according to OECD guidelines and followed GLP.