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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 15-NOV-1993 to 11-APR-1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to a recognised guideline and 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

Constituent 1
Chemical structure
Reference substance name:
Ethyl methyl sulphide
EC Number:
210-868-4
EC Name:
Ethyl methyl sulphide
Cas Number:
624-89-5
Molecular formula:
C3H8S
IUPAC Name:
(methylsulfanyl)ethane
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: other: EU and GHS
Conclusions:
The acute oral LD50 of Methyl Ethyl Sulfide 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 sulfide 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.