4-[(4-ethoxyphenyl)amino]-N,N-dimethyl-3-nitrobenzenesulphonamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The test was conducted on a similar substance. The complete justification for the read across is attached at section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Guidelines followed

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar substance 01

IUPAC Name:

Similar substance 01

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2 - 3 kgs
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 30-70
- Air changes (per hr): 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye remained untreated and served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

Single injection

Observation period (in vivo):

1, 24, 48, and 72 hours

Number of animals or in vitro replicates:

3 animals

Details on study design:

SCORING SYSTEM: The ocular irritation scores were evaluated according to the gradings mentioned in "Grades for ocular lesions"

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

The substance showed to be slightly irritant and not corrosive

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to the CLP Regulation

Conclusions:

The substance is not irritant and not corrosive.

Executive summary:

The purpose of the study was to find out the eye irritation potential of test item in rabbits. The study was conducted according to OECD guidelines 405.

The test substance was placed into the conjunctival sac of the right eye of each animal in the amount of 0.1 g after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as a control.

The eyes were examined at 1, 24, 48, and 72 hours after substance instillation.

Under the conditions of the present experiment the substance was found to be not irritant when applied to the rabbit eye mucosa according to the CLP Regulation (EC n. 1272/2008).