1-(6-FLUORO-3,4-DIHYDRO-2H-CHROMEN-2-YL)ETHANONE

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-01-12 to 2005-02-18

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

The test substance is not adequately characterized and insufficient information is provided on the test animals.

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

yes

Remarks:

The test substance is not adequately characterized and insufficient information is provided on the test animals.

GLP compliance:

no

Remarks:

This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)ethan-1-one

Cas Number:

620176-90-1

Molecular formula:

C11H11FO2

IUPAC Name:

1-(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)ethan-1-one

Details on test material:

- Name of test material: T 1481

Test animals

Species:

mouse

Strain:

other: outbred albino

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 18-22 grams
- Fasting period before study: animals were fasted, however, fasting period not provided.
- Housing: no data
- Diet: no data
- Water: no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES:
- no data

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: arachis oil BP

Details on oral exposure:

VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle: no data
- Justification for choice of vehicle: no data
- Lot/batch no.: no data
- Purity: no data


MAXIMUM DOSE VOLUME APPLIED:
- no data

DOSAGE PREPARATION:
- no data


CLASS METHOD:
- Rationale for the selection of the starting dose: no data

Doses:

300 and 2000 mg/kg bodyweight

No. of animals per sex per dose:

Three animals per group. There were two groups at 300 mg/kg bw dose level and one group at 2000 mg/kg bw dose level.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and clinical observations were noted at 30 minutes, 1, 2, 4 hours after dosing, and daily from days 1-14 following administration. Body weights were recorded on days 0, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examination

Statistics:

no data

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

300 - 500 mg/kg bw

Mortality:

There were no deaths noted in animals treated at a dose level of 300 mg/kg. All animals treated at a dose level of 2000 mg/kg were found dead or killed in extremis during the day of dosing.

Clinical signs:

other: Hunched posture, lethargy and ptosis were noted, during the day of dosing, in animals treated at a dose level of 300 mg/kg. Animals treated at a dose level of 300 mg/kg appeared normal four hours or one day after dosing. Signs of systemic toxicity noted,

Gross pathology:

No abnormalities noted.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral LD50 of the test substance in the female outbred albino mouse was estimated to be in the range of 300 to 500 mg/kg bodyweight.