2,4,6-tribromophenol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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
- Purity test date: 99%

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 213 to 241 grams for males, 213 to 239 for females
- Fasting period before study: No
- Housing: Individually during 24 hour exposure period, and in groups of five, by sex for remainder of study
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1, ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23 °C
- Humidity (%): 47-56%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks
- % coverage: 10% of total body surface area
- Type of wrap if used: surgical gauze and self-adhesive bandage and BLENDERM to secure the bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with cotton wool moistened with arachis oil BP
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg

- Constant volume or concentration used: yes

Duration of exposure:

24-hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Days 0, 7, and 14 for weighing; observed at 1/2, 1,2, and 4 hours after dosing and subsequently once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological observation of abdominal and thoracic cavities

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

other: No signs of systemic toxicity were noted during study.

Gross pathology:

No abnormalities were noted.

Other findings:

No signs of skin irritation noted during the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median dose (LD50) of the test material Tribromophenol in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.