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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 June 1992

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Irritant when tested as a 20% solution, so no conclusion for undiluted substance. No scoring for iris and cornea reactions and only one animal investigated, excluding distinction between R36 and R41.

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 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

yes not tested as such but as a solution in DMSO: inapropriate/insufficient exposure; inflammatory
reactions in one animal should have been further investigated in additional animals after local
anesthesia

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: breeder
- Age at study initiation: no data
- Weight at study initiation: mean of 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: 1992/06/25 (day 1)

Test system

Vehicle:

other: DMSO

Controls:

other: The right eye served as control (received the DMSO alone)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL in the left eye
- Concentration (if solution): 20% in DMSO

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

One hour

Number of animals or in vitro replicates:

One

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: none

Results and discussion

In vivo

Results

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 1 hour

Score:

ca. 4

Reversibility:

other: Animal killed for human reason

Remarks on result:

other: The chemosis masked all the cornea and iris.

Irritant / corrosive response data:

One hour after instillation, a severe chemosis (grade 4) covering the iris and cornea was observed.
The animal was then sacrificed: no data on reversibility.

Other effects:

No ocular reaction was noted after DMSO instillation (right eye).

Applicant's summary and conclusion

Interpretation of results:

other: Xi/R41 based on severity, but reversibility not assessed; the substance was used diluted Crit eria used for interpretation of results: EU

Conclusions:

The substance (diluted at 20%) was considered to be irritant to eyes (Xi/R41 based on severity of the chemosis - but its reversibility could not be assessed as the animal was sacrificed).