2-ethyl-4-hydroxy-5-methylfuran-3(2H)-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

fixed dose procedure

Test material

Test material information

1

Reference substance name:

2-ethyl-4-hydroxy-5-methylfuran-3(2H)-one

EC Number:

248-514-6

EC Name:

2-ethyl-4-hydroxy-5-methylfuran-3(2H)-one

Cas Number:

27538-10-9

Molecular formula:

C7H10O3

IUPAC Name:

2-ethyl-4-hydroxy-5-methylfuran-3(2H)-one

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

No. of animals per sex per dose:

3 females

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Mortality of 2/3 females at limit dose of 2000 mg/kg body weight was noted. One female was sacrificed for human reasons. All 6/6 females survived the dose of 300 mg/kg body weight

Clinical signs:

Test item-related mortality in females treated with the test item in dose of 2000 mg/kg body weight was observed within few minutes after administration of the test item. Immediately after administration of the test item, lethargy was observed in animal No 3, animals No 1 and No 2 were sleepy and it persisted to the next day. Dyspnea was observed in animals No 1 and No 2 within first 30 minutes. Animal No 3 died in a few minutes after administration of the test item, animal No 2 was found dead on the next day and animal No 1 was euthanised for human reasons.
No mortality was observed in females treated with the test item at dose of 300 mg/kg body weight. During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reaction negative reactions.

Body weight:

The body weights of all animals treated with the dose of 300 mg/kg increased during the study. A slight decrease in body weights in animals No 4 and No 8 and a stagnation of body weights in animal No 6 and No 7 were observed between the first and second week after administration.

Gross pathology:

All animals were necropsied. Animal No 2 could not be necropsied because cadaver was autolysed. Blood in gastrointestinal tract and diffusely altered the colour of the of stomach mucosa were registered in animal No 1 which was sacrificed.
All animals treated with dose of 300 mg/kg body weight were necropsied. During necropsy, no macroscopic findings were noticed.

Any other information on results incl. tables

Table1Administration Results

Sex	Dose	ID	Result	Sex	Dose	ID	Result
♀	2000 mg/kg	1	euthanasia	♀	300 mg/kg	4	alive
		2	dead			5	alive
		3	dead			6	alive
		-	-			7	alive
		-	-			8	alive
		-	-			9	alive

Table2Clinical Observation

Observation	Time After Administration
	Hour					Day
	I	0.5	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
Skin and Hair	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Eyes	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Mucosa	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Respiratory System	-	No 2, 1*	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Circulatory System	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
CNS	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Somatomotoric Activity	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Tremor	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Spasms	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Salivation	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Diarrhoea	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Lethargy	No 3	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Sleep	No 2, 1	No 2, 1	No 2, 1	No 2, 1	No 2, 1	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Coma	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Death	No 3	-	-	-	-	No 2 No 1**	-	-	-	-	-	-	-	-	-	-	-	-	-

I-Immediately,-No observed signs, *- dyspnea, **- euthanasia

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	160	-	-	-	-	-
		2	177	-	-	-	-	-
		3	160	-	-	-	-	-
	300 mg/kg	4	200	221	215	21	15	- 6
		5	202	207	209	5	7	2
		6	197	209	209	12	12	0
		7	203	227	227	24	24	0
		8	201	214	209	13	8	-5
		9	197	211	216	14	19	5

Table4Necropsy Results

Sex	Dose	ID	Result	Sex	Dose	ID	Result
♀	2000 mg/kg	1	blood in GIT red colour of stomach mucosa	♀	300 mg/kg	4	no finding
		2	autolytic changes			5	no finding
		3	no finding			6	no finding
		-	-			7	no finding
		-	-			8	no finding
		-	-			9	no finding

 

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 of the test item Furanone Homo is higher than 300 mg/kg body weight and lower than 2000 mg/kg body weight after single oral administration to Wistar rats.
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 Furanone Homo is according to UN Globally Harmonized System of Classification, Labelling and Packaging of Chemicals classified Category 4 with a LD50 cut off value 500 mg/kg body weight according to Regulation (EU) Nr. 1272/2008 (CLP), after single oral administration to Wistar rats.