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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Propanoic acid, 2-hydroxy-, 2-ethylhexyl ester, (2S)-
EC Number:
606-097-1
Cas Number:
186817-80-1
Molecular formula:
C11H22O3
IUPAC Name:
Propanoic acid, 2-hydroxy-, 2-ethylhexyl ester, (2S)-
Constituent 2
Reference substance name:
2-ethylhexyl-S-lactate
IUPAC Name:
2-ethylhexyl-S-lactate
Details on test material:
Batch no.: EHL-002-3
Purity: 98.6 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Breeding Centre for Laboratory Animals "Charles River Wiga GmbH", Sulzfeld, F.R. Germany
- Age at study initiation: young adult (7 weeks old)
- Weight at study initiation: 170 to 188 g for males and 134 to 151 g for females
- Fasting period before study: overnight
- Housing: The rats were housed in groups of five animals, males and females separated. They were kept in stainless cages with wire-screen bottom and front.
- Diet (e.g. ad libitum): the Institute's cereal-based, open-formula basal diet for rats, ad libitum
- Water (e.g. ad libitum): tap water was freely available at alle times by means of an automatic watering system
- Acclimation period: 2 weeks

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

IN-LIFE DATES: September 19, 1989 to October 16, 1989

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
maize oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 % (w/v)
- Amount of vehicle (if gavage): 10.0 ml/kg body weight
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- 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. Individual body weights were recorded on day 0, 3, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:
A preliminary study was carried out to find the general level of acute toxicity of the test substance; data of this preliminary study are not presented in the report.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred, see Table 1.
Clinical signs:
At 1 and 4 hours after treatment all animals showed moderate signs of piloerection. These signs of intoxication were not observed 24 hours after treatment and thereafter.
Body weight:
All animals gained weight after 3 days and thereafter, see Table 1.
Gross pathology:
Macroscopic examination at the end of the observation period did not reveal any teatment-related gross alterations.

Any other information on results incl. tables

Table 1. Acute oral toxicity of "S(-)-2-ethyl hexyl lactate" in groups of five male and five female rats. Dose applied, mean body weights and mortality figures.

 

Test substance (mg/kg)

Mean body weight (g) on day

Mortality

(per 5 animals)

Sex

 

0

3

7

14

 

Males

2000

179

213

244

272

0/5

Females

2000

142

167

179

183

0/5

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 2-ethylhexyl-S-lactate is clearly less than the limit for classification as harmful.
Executive summary:

In an acute oral toxicity study (OECD guideline 401, limit test), groups of five male and five female, 7 weeks old Wistar outbred rats, fasted overnight, were given a single oral dose of 2-ethylhexyl-S-lactate in maize oil at a dose of 2000 mg/kg bw and observed for 14 days. No mortality occurred.

The oral LD50 in males and females was > 2000 mg/kg bw. 2-Ethylhexyl-S-lactate is of low toxicity based on absence of mortality at the limit dose in males and females.