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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl lactate
EC Number:
202-598-0
EC Name:
Ethyl lactate
Cas Number:
97-64-3
Molecular formula:
C5H10O3
IUPAC Name:
ethyl 2-hydroxypropanoate
Test material form:
liquid
Remarks:
colorless transparent liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Doses:
The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. A limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item-related mortality wasobserved during 24 hours (one animal died) and therefore,after another 24 hours,3 females were treated at the same dose.
No. of animals per sex per dose:
The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. A limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item-related mortality wasobserved during 24 hours (one animal died) and therefore,after another 24 hours,3 females were treated at the same dose.

Results and discussion

Preliminary study:
The test item Ethyl lactate administered to 6 females at a limit dose of 2000 mg/kg body weight caused death of two animals. Piloerection was observed during the observation period.The body weights of the rest animals increased during the study. No body weight losses were observed between the first and second week after administration. During necropsy, no macroscopic findings were observed.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
2
Body weight:
The body weights of animals No 1, 3, 4 and 6 increased during the study. A slight decrease in animal No 3 was noticed during the first post-treatment week. No body weight losses were observed between the first and second week after administration of the test item. Summary results of body weights are presented in Table 3.

Any other information on results incl. tables

4/6 animals survived the limit dose of 2000 mg/kg body weight.

Sex

Dose

ID

Result

Sex

Dose

ID

Result

2000

mg/kg

1

alive

2000

 mg/kg

4

alive

2

dead

5

dead

3

alive

6

alive

Test item-related mortality was observed within24 hours. Animals No 2 and No 5 died day after administration of the test item.Animal No 5 died probably during the night hours, because cadaver was in a state of autolysis.

Table3Body Weight

Sex

Dose

ID

Body Weight (g)

Body Weight Difference (g)

Initial

Week 1

Week 2

Week 1 - Initial

Week 2 - Initial

Week 2 - Week 1

2000 mg/kg

1

190

190

210

0

20

20

2

185

-

-

-

-

-

3

190

185

200

-5

10

15

4

195

215

225

20

30

10

5

170

-

-

-

-

-

6

195

220

225

25

30

5

All animals were necropsied. During necropsy, no macroscopic findings were observed.AnimalNo 5 could not be necropsied because of autolysed cadaver.

Table4NecropsyResults

Sex

Dose

ID

Result

Sex

Dose

ID

Result

2000 mg/kg

1

no finding

2000 mg/kg

4

no finding

2

no finding

5

autolytic changes

3

no finding

6

no finding

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The LD50 of the test item Ethyl lactate is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Executive summary:

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Ethyl lactate is according to UN Globally Harmonized System of Classification, Labelling and Packaging of Chemicals classified in Category 5 with a LD50 cut off value 2500 mg/kg body weight according to Regulation (EU) Nr. 1272/2008 (CLP), after single oral administration to Wistar rats.

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