Registration Dossier

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

Constituent 1
Chemical structure
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.

Applicant's summary and conclusion