Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
(Photoperiod (hrs dark / hrs light): 10/14, occlusive treatment, 8 day-post treatment observation, no necropsy examinations)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

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-1,2,3-benzotriazol-2-yl)-4-methylphenol
Test material form:
solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): TK 10048
- Lot/batch No.: Dated 16.10.71

Test animals

Species:
rat
Strain:
other: CFE (RAC; SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Local suppliers
- Age at study initiation: no data
- Weight at study initiation: 123 - 133 g
- Fasting period before study: no data
- Housing: groups of 5 in macrolon cages (type 3)
- Diet: Nafag; ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10/14


Administration / exposure

Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
(0.5% in water)
Details on dermal exposure:
TEST SITE
- Area of exposure: 100 cm²/kg bw
- Type of wrap if used: occlusive dressing held in place with an adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Constant volume or concentration used: yes (50%)
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): 0.5%
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: 8 days
- Frequency of observations and weighing: daily observations, weighed at end of study
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/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:
No clinical signs of toxicity were observed up to the end of the 8-day observation period.
Body weight:
Average body weight increased from 126 g to 171 g during the test.
Gross pathology:
not performed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met