1-bromo-4-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:

data from handbook or collection of data

Justification for type of information:

Data is from publication

Data source

Reference

Reference 1

Reference Type:

other: authoritative database

Title:

Acute oral toxicity study in Rat.

Author:

U.S. National Library of Medicine

Year:

2017

Bibliographic source:

ChemIDplus

Reference 2

Reference Type:

other: Data is from authoritative database

Title:

Acute oral toxicity of test chemical in rat

Author:

IFA GESTIS

Year:

2018

Bibliographic source:

GESTIS Substance Database, 2018

Reference 3

Reference Type:

secondary source

Title:

Review of Toxicological Literature

Author:

National Toxicology Program (NTP)

Year:

2005

Bibliographic source:

National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health, U.S Department of Health and Human Services, January 2005

Reference 4

Reference Type:

secondary source

Title:

Initial submission: Median lethal dose toxicity study with test chemical in Rats with cover letter

Author:

NTRL

Year:

1986

Bibliographic source:

NTRL report, 0TSO540497- 10/15/1986

Reference 5

Reference Type:

other: Data is from authoritative database

Title:

Acute oral toxicity of test chemical in rats

Author:

RTECS

Year:

2018

Bibliographic source:

RTECS (registry of toxic effect of chemical substance data base), 2018

Reference 6

Reference Type:

publication

Title:

: Provisional Peer-Reviewed Toxicity Values for test chemical

Author:

U.S. Environmental Protection Agency (USEPA) National Center for Environmental Assessment (NCEA) Office of Research and Development (ORD)

Year:

2017

Bibliographic source:

Provisional Peer-Reviewed Toxicity Values for test chemical, EPA/690/R-17/005,09-25-2017

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Acute oral toxicity study of test chemical in rats

GLP compliance:

not specified

Test type:

other: Single dose acute oral toxicty

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-bromo-4-fluorobenzene

EC Number:

207-300-2

EC Name:

1-bromo-4-fluorobenzene

Cas Number:

460-00-4

Molecular formula:

C6H4BrF

IUPAC Name:

1-bromo-4-fluorobenzene

Constituent 2

Reference substance name:

4-Bromofluorobenzene

IUPAC Name:

4-Bromofluorobenzene

Test material form:

other: liquid

Details on test material:

- Name of test material :4-Bromofluorobenzene (4-BFB)
- Molecular formula :C6H4BrF
- Molecular weight :175.0 g/mole
- Substance type:Organic
- Physical state:Clear coloureless to slightly yellow liquid
Purity98 %
- Impurities (identity and concentrations):2 %

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, New york
- Age at study initiation: 8 weeks old
- Housing: Animals were housed singly in suspended, stainless steel, wire –mash cages with dimensions of 8” X 14” X 8” (wXdXh). Each rat was assigned a unique identification number which was recorded on a card affixed to the cage.
- Diet (e.g. ad libitum): Purina certified rodent chow #5002, ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: 8 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2 °C
- Humidity (%): 50 ± 10%
- Photoperiod (hrs dark / hrs light): Timer-controlled, 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 3/20/85
To: 5/22/85

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 1000, 2000, 3000 and 5000 mg/kg bw
- Justification for choice of vehicle: Marola corn oil

DOSAGE PREPARATION (if unusual): 4-Bromofluorobenzene (4-BFB) as emulsion in Marola corn oil.

Doses:

1000, 2000, 3000 and 5000 mg/kg bw

No. of animals per sex per dose:

Total : 40
1000 mg/kg bw: 10 male
2000 mg/kg bw: 10 male
3000 mg/kg bw: 10 male
5000 mg/kg bw: 10 male

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs and body weight were examined.

Statistics:

LD50 values were calculated from the mortality data using method of 0.0.Finney.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

2 700 mg/kg bw

Based on:

test mat.

95% CL:

> 2 200 - < 3 200

Remarks on result:

other: No effect on survival, clinical and body weight

Mortality:

At 3000 mg/kg and 5000 mg/kg bw, 7 and 10 male rats were dead, 1 at 2000 mg/kg bw and no effect on survival of 1000 mg/kg bw treated rats were observed.

Clinical signs:

other: Tremor, Limpness change in motor activity, clear discharge from eyes and ataxia were observed in treated rats.

Gross pathology:

No data available

Other findings:

No data available

Any other information on results incl. tables

Sr no.	Dose rate	Average body weight	Emulsion concentration (mg/ml)	Average dose	Mortality ratio
1	1000	231(227-243)	225	1.0	0/10
2	2000	251(235-268)	300	1.7	1/10
3	3000	242(226-253)	300	2.4	7/10
4	5000	259(255-267)	300	4.3	10/10

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

LD50 was considered to be 2700 mg/kg bw (2200 – 3200 mg/kg ) when Crl:CD (SD)BR male rats were treated with test chemical orally by gavage.

Executive summary:

In a acute oral toxicity study,Crl:CD (SD)BR male rats were treated with test chemical in the concentration of 1000, 2000, 3000 and 5000 mg/kg bw as emulsion in Marola corn oil orally by gavage and observed for 14 days. 7 and 10 male rats were dead at 3000 mg/kg and 5000 mg/kg bw, 1 at 2000 mg/kg bw and no effect on survival of 1000 mg/kg bw treated rats were observed. Tremor, Limpness change in motor activity, clear discharge from eyes and ataxia were observed in treated rats. Slight to sever decrease in body weight were observed in treated rats. Therefore,LD50 was considered to be 2700 mg/kg bw(2200 – 3200 mg/kg ) whenCrl:CD (SD)BR male rats were treated with test chemical orally by gavage.