2(3H)-Furanone, dihydro-3-hydroxy-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Acute oral toxicity was determined according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-hydroxyoxolan-2-one

EC Number:

692-561-9

Cas Number:

19444-84-9

Molecular formula:

C4H6O3

IUPAC Name:

3-hydroxyoxolan-2-one

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Number: nine nulliparous and non-pregnant female rats were received at CIT between 25 August and 08 September 2011.
-Strain and Sanitary status: Sprague-Dawley rat, Rj Han: SD, Indemn of Organism Pathogen Specific Han (IOPS Han).
-Breeder: Janvier, Le Genest-Saint-Isle, France.
-Age/Weight: on the day of treatment, the females were approximately 8 weeks old and had a mean body weight of 204 g (range: 188 g to 216 g).
-Receipt: on arrival, the animals were given a clinical examination to ensure that they were in good condition.
-Acclimation: the animals were acclimated to the study conditions for a period of 5 or 6 days before treatment.
-Allocation to groups: the day before treatment, the required number of animals (three females per treatment step) were allocated to the groups according to a computerized random procedure.
-Identification: the day before treatment, the animals were individually identified by ear notches (unique identity number).

The animal room conditions were set as follows:
-temperature : 22 ± 2°C,
-relative humidity : 50 ± 20%,
-light/dark cycle : 12h/12h (7:00 - 19:00),
-ventilation : approximately 12 cycles/hour of filtered, non-recycled air.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

No. of animals per sex per dose:

3 females: 300mg/Kg
3 females: 2000mg/Kg
3 females: 2000mg/Kg

Control animals:

no

Details on study design:

-Duration of observation period following administration: 14 days.
-Frequency of observations : . at least once during the first 30 minutes, . periodically during the first 4 hours, . then once a day, at approximately same time, for the recording of clinical signs.
-Necropsy of survivors performed: yes.
-Other examinations performed: clinical signs and body weight.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No unscheduled deaths occurred during the study.

Clinical signs:

other: No clinical signs were observed at 300 mg/kg and 2000 mg/kg.

Gross pathology:

No macroscopic post-mortem findings were observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, the oral LD50 of the test item, 2-Hydroxy Gamma ButyroLactone, was higher than 2000 mg/kg in rats.
Therefore, the test item should not be classified as toxic by oral route according to the criteria of CLP Regulation.