Bumetrizole

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1961

Report date:

1961

Materials and methods

Principles of method if other than guideline:

10 rats were treated once a day on 6 consecutive days for 4 weeks (4 x 6 days) with 0.4 mL/animal of the test substance in vehicle always to the same dorsal skin area. Animals were observed for local irritation and systemic toxic effects.

GLP compliance:

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): GP 38771/I
- Substance No.: GP 38771

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 120-125 g; mean: 121 g

Administration / exposure

Type of coverage:

open

Vehicle:

other: gum arabic

Details on exposure:

TEST SITE
- Area of exposure: no data
- Type of wrap if used: no data
- Time intervals for shavings or clipplings: depilation of dorsal skin by shearing before application

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, 3 hours after application with a moist sponge

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.4 mL/animal/day (sundays excluded)
- Concentration (if solution): 5% in gum arabic.
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of treatment / exposure:

4 weeks

Frequency of treatment:

(daily application for 3 hours; sundays excluded)

Doses / concentrations

Dose / conc.:

0.4 other: ml

Remarks:

total volume (5% in vehicle)

No. of animals per sex per dose:

5

Control animals:

no

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: no data

DETAILED CLINICAL OBSERVATIONS: No data

DERMAL IRRITATION: Yes
- Time schedule for examinations: no data

BODY WEIGHT: Yes
- Time schedule for examinations: at study initiation and end of study

FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data

WATER CONSUMPTION: No

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: No

CLINICAL CHEMISTRY: No

URINALYSIS: No

NEUROBEHAVIOURAL EXAMINATION: No

Sacrifice and pathology:

GROSS PATHOLOGY: No data
HISTOPATHOLOGY: No data

Results and discussion

Results of examinations

Details on results:

- Body weight:
Day 29: 164 - 217 g; mean: 186

Target system / organ toxicity

Critical effects observed:

no

Any other information on results incl. tables

-Results:

No local irritating effect.

No systemic effect.