2,1,3-Benzoxadiazole, 4,6-dinitro-, 1-oxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 June 1992 to 21 June 1992

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Inappropriate removal of test item at 4h, as a brownish coloration of skin was attributed to remaining test item. Irritant when tested as a 20% solution, so no conclusion for undiluted substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

not tested as such but as a solution in DMSO: inapropriate/insufficient exposure

GLP compliance:

yes

Remarks:

no laboratory GLP certificate, no analytical certificate

Test material

Test material information

Constituent 1

Reference substance name:

4,6-dinitro-2,1λ⁵,3-benzoxadiazol-1-one

EC Number:

700-179-1

Cas Number:

5128-28-9

Molecular formula:

C6H2N4O6

IUPAC Name:

4,6-dinitro-2,1λ⁵,3-benzoxadiazol-1-one

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeder
- Age at study initiation: no data
- Mean weight at study initiation: 2.6 kg
- Housing: individual
- Diet: conventional laboratory diet, ad libitum
- Water : filtered water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours
IN-LIFE DATES: From: 18 June 1992 To: 21 June 1992

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: dimethylsulfoxide

Controls:

other: the left flank of the animals served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL per animal
- Concentration (if solution): 20% in DMSO

Duration of treatment / exposure:

4 hours

Observation period:

4 days: 1, 24, 48 and 72h after application

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: aerated hypoallergenic adhesive semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

other: scoring masked by brownish coloration of the skin Irritation parameter erythema score Basis animal #2 Time point other: 24, 48 and 72 hours Remarks on result other: scoring masked by brownish coloration of the skin

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

other: scoring masked by brownish coloration of the skin

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

other: scoring masked by brownish coloration of the skin

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

4

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Irritant / corrosive response data:

On the right flank (test item), a slight to severe edema (grade 2 to 4) was observed in all animals 24,
48 and 72 hours after the treatment. Erythema assessment was masked by the brownish coloration of the skin (due to the substance). All the a
nimals were sacrificed on day 4.

Other effects:

On the left flank of the animals (DMSO alone), very sight to slight erythema and edema were
observed one hour after dressing removal.
Brownish coloration of skin attributed to remaining test item (although the remaining test item was s
tated to be removed before scoring).

Any other information on results incl. tables

Left flank: Very slight to moderate erythema and edema 1h after removal only.

Right flank (treated): Slight to severe edema (score of 2 in 2 animals, 4 in 1 animal) up to 72h after

removal. Remaining brown test item masks erythema scoring. No microscopic examination of tissues

has been performed.

Applicant's summary and conclusion

Interpretation of results:

other: possibly Xi/R38 or C/R34/R35; definitive classification not possible as the substance was used diluted Criteria used for interpretation of results: EU

Conclusions:

The substance (diluted at 20%) was considered to be irritant to skin Xi/R38. No conclusion for the undiluted substance.