2,4,6-tribromophenol

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,4,6-tribromophenol

EC Number:

204-278-6

EC Name:

2,4,6-tribromophenol

Cas Number:

118-79-6

Molecular formula:

C6H3Br3O

IUPAC Name:

2,4,6-tribromophenol

Test material form:

solid: granular

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: MANAC, Hiroshima, JAPAN; Lot No.: 70909
- Purity test date: 99.8 wt %

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Japan Charles River, Atsugi-city, Kanagawa prefecture
- Age at study initiation: 6 weeks
- Weight at study initiation: 5 males of 175 to 202 g body weight and 5 females of 130 to 156 g body weight were selected.
- Fasting period before study: 16 hours
- Housing: 5 rats per cage, breeding cages of 21.5 x 27.5 x 19.5 cm were used; bedding and cage bottom not specified.
- Diet (e.g. ad libitum): ad libitum to food pellets from Oriental Yeast Co, Ltd. No diet details given. Contaminants in food were confirmed within allowable standards.
- Water: tap water ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200, 260, 338, 439.4 and 571.2 mg of the test substance (99.8 wt % purity) were suspended in corn oil.
- Amount of vehicle (if gavage): 0.5 mL/100 g bw suspended solution.

Doses:

1000, 1300; 1690; 2197 and 2856 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: every 1 hr till 6 hrs after administration. After 6 hrs, twice/day
- Necropsy of survivors performed: yes
- Other examinations performed: Appearances and activities of surviving animals were observed. Dead animals and survived animals were dessected just after died and after 14 days test respectively. Macroscopical and pathological findings were recorded.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 486 mg/kg bw

Based on:

test mat.

95% CL:

ca. 1 215 - ca. 1 792

Mortality:

Deaths of both sexes occurred in the 1300 mg/kg and more groups.
1000 mg/kg - 0%
1300 mg/kg - 40%
1690 mg/kg - 80%
2197 mg/kg - 80%
2866 mg/kg - 100%

Clinical signs:

other: Hypoactivity was observed in all groups and salivation appeared in most of animals. Furtheremore, in 1300 mg/kg or higher groups of both sexes, chlonic convulsions, tremors, adoption of a prone and/or lateral position were observed before the animals die

Gross pathology:

No macroscopic abnormalities were observed by autopsy for either of the dead animals and the survived animals.

Any other information on results incl. tables

Numbers of dead animals by doses

[Males]

------------------------------------------------------------------------------------------

Dose        Number of       Number of deaths       Mortality

(mg/kg)       animals         day 1   day 2-14

------------------------------------------------------------------------------------------

1000              5                     0         0              0 / 5

1300              5                     2         0                 2 / 5

1690              5               4        0                 4 / 5

2197              5                    4         0                 4 / 5

2856              5                     5        -                 5 / 5

------------------------------------------------------------------------------------------

[Females]

------------------------------------------------------------------------------------------

Dose       Number of       Number of deaths       Mortality

(mg/kg)       animals         day 1 day 2 -14

------------------------------------------------------------------------------------------

1000              5               0        0                0 / 5

1300              5                    2        0               2 / 5

1690              5                    4          0               4 / 5

2197              5               4          0                4 / 5

2856              5                    5          -               5 / 5

------------------------------------------------------------------------------------------

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based on the data obtained, the LD50 of 2,4,6-tribromophenol was determined to be 1486 mg/kg with 95% confidence intervals of 1215 - 1792 mg/kg when administered once orally via gavage to male and female rats.