Bumetrizole

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test performed according to proposed guideline

Remarks:

Incomplete characteriszation of the test substance e.g. no details on test material purity

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Proposed Guidelines of the US EPA § 163.81-5 'Primary dermal irritation study' (1978-08-22)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(occlusive treatment, 24 h exposure duration)

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 material (as cited in study report): TK 10048
- Physical appearance: yellow powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ivanovas, 7964 Kisslegg/Allgaeu, Germany; Madoerin AG, 4414 Fuellinsdorf, Switzerland)
- Age at study initiation: adult
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet: NAFAG No. 814 (Gossau AG); ad libitum
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 / 10

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved (one side abraded, other side intact)

Vehicle:

other: propylene glycol : saline (70 : 30)

Controls:

other: untreated site served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration: 50% w/w

Duration of treatment / exposure:

24 h

Observation period:

7 days

Number of animals:

6 (3 per sex)

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patches covered with an impermeable material and fastened to the body with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: no data

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3, #4, #5, respectively

Time point:

other: mean over 24, 48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: intact skin

Results 2

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

other: mean over 24, 48 and 72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: intact skin

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: intact skin

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

#1, #2, #3, #4, #5, respectively

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: intact skin

Results 5

Irritation parameter:

edema score

Basis:

animal #6

Time point:

other: mean over 24, 48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: intact skin

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0.06

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: intact skin

Other effects:

Scores for abraded skin were not taken into account for evaluation.

Any other information on results incl. tables

Table 1: Results from abraded skin.

	Animal 1		Animal 2		Animal 3		Animal 4		Animal 5		Animal 6
	Er	Ed	Er	Ed	Er	Ed	Er	Ed	Er	Ed	Er	Ed
24 hours	1	0	1	0	1	0	2	1	1	0	1	0
48 hours	0	0	0	0	0	0	1	0	0	0	0	0
72 hours	0	0	0	0	0	0	0	0	0	0	0	0
7 day	0	0	0	0	0	0	0	0	0	0	0	0

Er = Erythema

Ed = Edema

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met