Fluorobenzene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented study which meets basic principles.

Data source

Reference

Reference Type:

publication

Title:

Acute oral toxicity and liver oxidant/antioxidant stress of halogenated benzene, phenol, and diphenyl ether in mice: a comparative and mechanism exploration

Author:

Shi J et al.

Year:

2013

Bibliographic source:

Environ Sci Pollut Res (2013) 20:6138-6149

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

GLP compliance:

not specified

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Fluorobenzene

EC Number:

207-321-7

EC Name:

Fluorobenzene

Cas Number:

462-06-6

Molecular formula:

C6H5F

IUPAC Name:

fluorobenzene

Details on test material:

Purity above 98 %

Test animals

Species:

mouse

Strain:

ICR

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Qinglongshan Animal Breeding Center of Nanjing, Jiangsu
- Age at study initiation: 6 weeks old
- Weight at study initiation:20.0 +/- 2.0g
- Fasting period before study: 3h
- Housing:Mice were caged in groups of ten using dust-free poplar chips for bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.0 +/- 1 °C
- Humidity (%): 55.0 +/- 5 %
- Air changes (per hr): 10 times/h
- Photoperiod (hrs dark / hrs light): 12/12 h light/dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: maize germ oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.1 to 0.2 mL/100g
- Rationale for the selection of the starting dose: The preliminary experiment: Four dose levels 100, 500, 2000, 5000 mg/kg bw amd three mice for each level were used. The general concentration range was determined after observation of death and evident toxicity in 7 days. Then the administration doses were graded with geometric progression for ease of the calculation of LD50.

Doses:

0, 3375.0, 5062.5, 7593.8 mg/kg bw

No. of animals per sex per dose:

10 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes

Statistics:

The data on organ/body coefficients and hepatic antioxidantive responses were statistically analyzed using the SPSS software package Version 12.0 for Windows (SPSS Company, CHicago, IL). Data were expressed as the mean+/-standard deviation (SD). All the analyzed parameters were checked for assumptions of normality using the Kolmogorov-Smirnov and homogeneity of variance using the Levene test, respectively. The differences between the control and experimental group were analyzed using one-way analysis of varinace followed by Dunnett's test. Differences were considered significant at p>0.05 and highly significant at p<0.01.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

7 593.75 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed in the low dose group, in the mid dose goup 2 animals died and in the highest dose group 4 animals died.

Clinical signs:

convulsions

Body weight:

lower than 10% body weight loss

Remarks:

No statistically significant changes were observed.

Other findings:

Exposure results in slight pathological changes in mouse liver.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met