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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

Constituent 1
Reference substance name:
ethylthioethanol
IUPAC Name:
ethylthioethanol
Constituent 2
Chemical structure
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.