Ethyl lactate

Acute Toxicity: oral

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

Test material information

Constituent 1

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

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.