2-bromo-5-hydroxy-4-methoxybenzaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-11-24 to 1998-01-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Remarks:

The testing facility indicated that the protocol was followed without deviation.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Remarks:

The testing facility indicated that the protocol was followed without deviation.

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

426-540-0

EC Name:

-

Cas Number:

2973-59-3

Molecular formula:

C8 H7 Br O3

IUPAC Name:

2-bromo-5-hydroxy-4-methoxybenzaldehyde

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Janssen Pharmaceutica N.V, 00265786
- Expiration date of the lot/batch: 01-Jul-1998
-Purity: 91.3%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the original container at room temperature away from direct sunlight.
- Solubility and stability of the test substance in the solvent/vehicle: Unknown.

Test animals

Species:

rat

Strain:

other: HanIbm:Wist (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Labolatories Ltd., Wolferstrasse 4, CH-4414 Fullinsdorf/Switzerland
- Age at study initiation: Males: 8 weeks, Females: 10 weeks
- Weight at study initiation: Males: 191-204 g, Females: 176-186 g
- Fasting period before study: Yes: for app. 19 h (access to water was permitted)
- Housing: In groups of five in Makrolon type-4 cages with standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 90/97 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland) ad libitum.
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: 1997-11-25 to 1997-12-01

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 deg C
- Humidity (%): 40-70 % (values above 70% during the cleaning process possible)
- Air changes (per hr): air-conditioned 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs light/ 12 hrs dark (music during the light period)

IN-LIFE DATES: From:1997-12-02 To: 1997-12-16

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

400

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2g/mL
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED
-10 mL/kg/bw

DOSAGE PREPARATION (if unusual)
-The test article was placed into a glass beaker on a tared Mettler PM 460 balance and the vehicle (polethylene glycol 400) was added.
- A weight by volume dilution was prepared using a magnetic stirrer as homogenizer.
- Homogeneity of the test substance in the vehicle was maintained.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 females 5 males per group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/ Viability: Four times during test day 1 and once daily during days 2-15;
Body weights: on test days 1 (prior to administration), 8 and 15;
Clinical signs: Each animal was examined for changes in appearance and behavior four times during day 1, and once during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was used.

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs of toxicity were observed during the study period.

Gross pathology:

No macroscopic findings were recorded at necroscopy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose of T002019 after single oral administration to rats of both sexes observed over a period 14 days is: LD50 (rat) greater than 2000 mg/kg body weight.