2-(ethylthio)ethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-12-01 to 2009-12-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD guideline and it was compliant with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

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)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

ethylthioethanol

IUPAC Name:

ethylthioethanol

Constituent 2

Reference substance name:

2-(ethylthio)ethanol

EC Number:

203-802-0

EC Name:

2-(ethylthio)ethanol

Cas Number:

110-77-0

Molecular formula:

C4H10OS

IUPAC Name:

2-(ethylsulfanyl)ethan-1-ol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd
- Age at study initiation: 8-12 wk
- Weight at study initiation: 215-257 g
- Housing: 3/solid bottomed polycarbonate cages with stainless steel mesh lid
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 40-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: 4 groups of 3 animals treated starting December 1, 4, 9 and 14 (2009). In-life dates for the first group were from: 2009-12-01 to 2009-12-15. The final group were necropsied on 2009-12-28.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

purified

Details on oral exposure:

VEHICLE
purified water

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

300, 2000 mg/kg bw

No. of animals per sex per dose:

2 groups of 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for mortality twice daily; clinical observations at unspecified frequent intervals during dosing day then twice daily until day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

None stated

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the study.

Clinical signs:

other: Clinical signs of reaction to treatment following administration of 2000 mg/kg bw comprised flat posture, underactivity, reduced body tone, unsteadiness, hunched posture, elevated gait, reduced body temperature, shallow and fast respiration, piloerection

Gross pathology:

A small (atrophy) stomach was seen in one animal dosed at 300 mg/kg bw at study termination. No treatment related abnormalities were noted in the remaining animals at the macroscopic examination at study termination on Day 15.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A reliable study conducted in compliance with a standard guideline and in accordance with GLP, found the LD50 to be greater than 2000 mg/kg bw in female rats.