Bumetrizole

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bumetrizole

EC Number:

223-445-4

EC Name:

Bumetrizole

Cas Number:

3896-11-5

Molecular formula:

C17 H18 Cl N3 O

IUPAC Name:

2-tert-butyl-6-(5-chloro-2H-benzotriazol-2-yl)-4-methylphenol

Test material form:

solid

Specific details on test material used for the study:

- Name of test substance (as cited in study report): Bumetrizol
- Analytical purity: 99.9% w/w
- Lot/batch No.: 01721IW4
- Stability under test conditions: Stable
- Storage condition of test material: Stored sealed in a cabinet at 20.0 - 25.3 deg C

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Japan (Hino Breeding center)
- Age at study initiation: 7 weeks (8 weeks at administration)
- Weight at study initiation: 182 - 204 g (185 - 201 g at administration)
- Fasting period before study: 18.5 - 19 hours before and up to 6 hours after administration
- Housing: Stainless steel cage
- Diet: CRF-1 (Oriental Yeast Co.); ad libitum
- Water: ad libitum
- Acclimation period: 5 days quarantine, 2 days acclimation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): 41 - 46
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Remarks:

0.5 % w/v solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 % w/v
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Information available from company literature that LD50 > 2000 mg/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females (3 in test 1 and 3 in test 2)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: General signs and death were observed up to 6 hours on the day of administration (0 - 30 min, 2, 4 and 6 hours after administration), then once per day from the following day during the observation period. Body weights were taken on the administration day (just before administration) and 1, 3, 7, 10 and 14 days after administration.
- Necropsy of survivors performed: yes

Statistics:

Mean and standard deviation calculated for body weights.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No animal died.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy examination revealed no substance-related findings.

Any other information on results incl. tables

Body weights (g):

Females	mg/kg bw	Test group 1	Test group 2
		2000	2000
Days after administration	0	185	199
	1	203	222
	3	209	230
	7	220	242
	10	232	255
	14	239	262

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met