5-propyloxan-2-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 March to 05 April 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study conducted in compliance with OECD Guideline No. 423 with minor deviations: age at study initiation, housing and feeding conditions, details of fasting not reported. These deviations do not affect the quality of the study and are not considered to be relevant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

17 December 2001.

Deviations:

yes

Remarks:

age at study initiation, housing and feeding conditions, details of fasting not reported

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

Directive N° 2004/73/EC.

Deviations:

yes

Remarks:

age at study initiation, housing and feeding conditions, details of fasting not reported

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

Inspected on 2005-10-03 / Signed on 2005-12-13.

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(5R)-5-propyloxan-2-one

Molecular formula:

C8 H14 O2

IUPAC Name:

(5R)-5-propyloxan-2-one

Constituent 2

Reference substance name:

(5S)-5-propyloxan-2-one

Molecular formula:

C8 H14 O2

IUPAC Name:

(5S)-5-propyloxan-2-one

Test material form:

liquid

Details on test material:

- Physical state: Colourless liquid
- Storage condition of test material: Room temperature

Specific details on test material used for the study:

- Test item was considered at 100% for the study.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle, France.
- Weight at study initiation: 208-228 g
- Fasting period before study: No data
- Housing: No data
- Diet: No data
- Water: No data
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21-23 °C
- Humidity: 38-60 %

IN-LIFE DATES: 21 March to 05 April 2006

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

distilled water

Details on oral exposure:

ADMINISTRATION: Animals received an effective dose of 2000 mg/kg bw of the test item, administered by force-feeding under a volume of 1.95 mL/kg bw using a suitable syringe graduated fitted with an oesophageal metal canula.

MAXIMUM DOSE VOLUME APPLIED: 1.95 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females/dose

Control animals:

yes

Remarks:

distilled water

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observations were performed 30 minutes, 1, 3 and 4 h after test substance administration, and once daily thereafter for 14 days.
- Frequency of weighing: Body weights were observed on Days 0, 2, 7 and 14.

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Remarks:

Cut-off

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality occurred during the study.

Mortality:

No mortality occurred during the study.

Clinical signs:

No clinical signs related to the administration of the test item were observed.

Body weight:

The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.

Gross pathology:

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the oral LD50 for test substance is higher than 2000 mg/kg bw, the LD50 cut-off being 5000 mg/kg bw in female rats therefore it is not classified according to the criteria of the Regulation EC No. 1272/2008 (CLP) and of the GHS.

Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, 6 female Sprague Dawley rats were given a single oral (gavage) dose of test substance at 2000 mg/kg bw administered by force-feeding under a volume of 1.95 ml/kg bw. A control group of 6 animals was administered with distilled water. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

No mortality occurred during the study. No clinical signs related to the administration of the test substance were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes. In this study, the oral LD50 of test substance was considered to be higher than 2000 mg/kg bw in female rats and the LD50 cut-off is 5000 mg/kg bw.

 

Under the test conditions, the test substance is not classified for acute oral toxicity according to the criteria of the Regulation EC No. 1272/2008 (CLP) and of the GHS.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.