Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 28, 1989 - October 12, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purasolv EL

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeding Centre for Laboratory Animals Çharles River Wiga GmbH", Sulzfeld, F.R. Germany.
- Age at study initiation: 5 weeks.
- Weight at study initiation: males: 139-158 g; females: 126-141 g.
- Fasting period before study: overnight.
- Housing: Groups of five animales, males and females separated in stainless cages eith wire-screen bottom and front.
- Diet (e.g. ad libitum): The Institute's cereal-based, open-formula basal diet for rats was fed to the animals ad libitum during the quarantine and study periods except for fasting prior to dosing.
- Water (e.g. ad libitum): Tap water was freely available at all times by means of an automatic watering system.
- Acclimation period: The rats were kept under the environmental conditions of the Institute's animal house for an acclimatization period of about 1 week prior to the test.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C.
- Humidity (%): 30-70%.
- Air changes (per hr): about 10 airchanges per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark.



IN-LIFE DATES: From: September 28, 1989 To:October 12, 1989

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The test substance was diluted with water in a concentration of 20% (w/v). The test dilution was given by gavage, in one single dose of 10 ml/kg body weight to five male and five female rats.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
A preliminary study was carried out to find the general level of acute toxicity for the test substance.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed frequently for signs of intoxication during the first 4 post-treatment hours and later on, at least once daily, throughout an observation period of 14 days. Individual body weights were recorded on day 0, 3, 7 and 14.
- Necropsy of survivors performed: At the end of the observation period, the rats were killed with carbon dioxide for macroscopic examination.
Statistics:
Since no mortality occurred a LD50 could not be calculated; a LD50 exceeding 2000 mg/kg body weight was given as a result.

Results and discussion

Preliminary study:
A prelimary study was carried out to find the general level of acute toxicity of the test substance; data of this preliminary study were not presented in the report.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occcurred
Clinical signs:
At 1, 4 and 24 hours after treatment all animals showed moderate signs of piloerection. These signs of intoxication were not observed 48 hours after treatment and thereafter.

Body weight:
All animals gained weight after 3 days and thereafter, and no mortality occurred.
Gross pathology:
Macroscopic examination at the end of the observation period did not reveal any treatment-related gross alteration.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity of ethyl-S-lactate is clearly less than the limit for classification as harmful
Executive summary:

Ethyl-S-lactate was administered to rats by oral gavage. The LD50 is higher than the upper limit for classification (2000 mg/kg bw).