2(5H)-Furanone, 5-hydroxy-4-methyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP / OECD Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Commission Directive 96/54/EC

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

5-hydroxy-4-methyl-2,5-dihydrofuran-2-one

EC Number:

609-869-6

Cas Number:

40834-42-2

Molecular formula:

C5 H6 O3

IUPAC Name:

5-hydroxy-4-methyl-2,5-dihydrofuran-2-one

Details on test material:

- Name of test material (as cited in study report): Hydroxybutenolid
- Physical state: solid/yellowish
- Analytical purity: 92.7% (potentiometric, titration)
- Lot/batch No.: unknown
- Date of production: March 06, 2000
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

other: Wistar (SPF) / Crl:WI (GLX/BRL/HAN)IGS BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Deutschland, Sandhofer Weg 7, 97633 Sulzfeld.
- Age at study initiation: male animals approx. 8 - 12 weeks; female animals approx. 12 - 18 weeks.
- Weight at study initiation: male animals 208 g; female animals 193 g (200 mg/kg dose group) or 173 g (2 000 mg/kg dose group).
- Fasting period before study: at least 16 h before administration.
- Housing: single housing
- Diet (e.g. ad libitum): Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2 or 20 g/100 ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: aqueous formulation correspond to the physiological medium.

MAXIMUM DOSE VOLUME APPLIED: approx. 2ml

Doses:

2 000 mg/kg b.w. in female animals
200 mg/kg b.w. in male and female animals

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights: day 0, 7 and 14; signs and symptoms: several times on day of administration, at least once the
following days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Mortality:

3/3 female animals died within 1 hour at the 2000 mg/kg b.w. dose level.
0/3 female animals and 0/3 male animals died at the 200 mg/kg b.w. dose level.

Clinical signs:

At the 2 000 mg/kg b.w. dose level, clinical signs comprised poor general state, dyspnoea, apathy, abdominal position, ataxia, atonia and paresis. These findings were observed during hour 0 after administration.

No clinical signs and findings werde observed at the 200 mg/kg b.w. dose level.

Body weight:

The mean body weights in the 200 mg/kg b.w. dose groups increased throughout the study period.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals that died and in the animals which were examined at the end of the observation period .

Any other information on results incl. tables

Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 200 mg/kg and less than 2,000 mg/kg body weight for male and female rats.

Applicant's summary and conclusion

Conclusions:

According to the results of this study, the substance was classified R22 (EU) and Cat. 4 (H302) accord. to CLP (1272/2008/EC).