Acetoin

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:

Acetoin

EC Number:

208-174-1

EC Name:

Acetoin

Cas Number:

513-86-0

Molecular formula:

C4H8O2

IUPAC Name:

3-hydroxybutan-2-one

Test material form:

liquid

Remarks:

a colourless 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. Available information indicated that the test item is likely to be non-toxic with regard to acute toxicity. A limit dose of 2000 mg/kg body weight was therefore used as a starting dose. One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore in a second step another 3 females were treated at the same dose level.

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. Available information indicated that the test item is likely to be non-toxic with regard to acute toxicity. A limit dose of 2000 mg/kg body weight was therefore used as a starting dose. One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore in a second step another 3 females were treated at the same dose level.

Results and discussion

Preliminary study:

The test item Acetoin was administered to 6 females Wistar rats at a limit dose of 2000 mg/kg. No mortality occurred during the study. No clinical signs related to the administration of the test item were observed during the first 4 hours or after the 14-day observation period. Stagnation of body weight in three animals between the first and second week was observed. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

0

Any other information on results incl. tables

All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.

Table1Administration Results

Sex	Dose	ID	Result	Sex	Dose	ID	Result
♀	2000 mg/kg	1	alive	♀	2000  mg/kg	4	alive
		2	alive			5	alive
		3	alive			6	alive

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	170	205	205	35	35	0
		2	185	205	220	20	35	15
		3	170	195	200	25	30	5
		4	180	205	210	25	30	5
		5	190	220	220	30	30	0
		6	190	210	210	20	20	0

All animals were necropsied. During necropsy, no macroscopic findings were observed.

Table4NecropsyResults

Sex	Dose	ID	Result	Sex	Dose	ID	Result
♀	2000 mg/kg	1	no findings	♀	2000 mg/kg	4	no findings
		2	no findings			5	no findings
		3	no findings			6	no findings

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 of the test item Acetoin is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Executive summary:

Based onAnnex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423itcan be concluded that thetest item Acetoinis classified in GHS Category 5/Unclassified with a LD₅₀cutoff value equal to or greater than5000 mg/kg body weight,after single oral administration to Wistar rats.