Bumetrizole

Acute Toxicity: dermal

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

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 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:

other: No clinical signs of toxicity were observed up to the end of the 8-day observation period.

Gross pathology:

not performed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met