3-[[2-(acetyloxy)ethyl][4-[(4-nitrophenyl)azo]phenyl]amino]propiononitrile

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:

From February, 2 to March 9, 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

for some descriptions and examinations; but it did not affect the validity of the study

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:

Breeder: Interfauna U.K. ltd.
Acclimatization period: at least 14 d
Body weight: 3.1-3.5 kg
Room temperature: 21 ± 1.5 °C
Humidity: 40 - 70 %
Light period: 12 h light/12 h dark
Diet and water: standard diet "Ssniff K4" and tap water, ad libitum

Test system

Vehicle:

physiological saline

Controls:

yes

Amount / concentration applied:

approx. 68 mg (in 100 µl)

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1, 24, 48, 72 h and 7 d

Number of animals or in vitro replicates:

3

Details on study design:

After gently pulling the lower lid away from the eyeball, a volume of 100 µl of the pulverized test substance (equivalent to approx. 68 mg) was placed into the conjunctival sac of one eye of each rabbit. The lids were then gently held together for about one second in order to limit loss of the material. 24 h after application of the test substance the treated eye was rinsed with normal saline.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 d

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 d

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

chemosis score

Basis:

animal: #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

other: not irritant according to the CLP Regulation (EC 1272/2008)

Conclusions:

Not irritant to rabbit eye.

Executive summary:

Method

Study conducted according to OECD guideline 405. Three female New Zealand White rabbits were exposed to test substance for 24 h. After gently pulling the lower lid away from the eye, a volume of 100 µl of pulverized test substance (equivalent to approximately 68 mg) was placed into the conjunctival sac of one eye of each rabbit. The lids were then gently held together for about one second in order to limit loss of the material. 24 h after instillation of the test substance, the treated eye was rinsed with normal saline.

Eye irritation (Draize scoring): signs of cornea (opacity, and area affected), iris (hyperaemia, reaction to light), conjunctivae i.e. conjunctiva of bulbus, lids, and nictitating membrane (erythema, chemosis), and discharge were recorded after 1, 24, 48, 72 h and 7 d. In parallel, the opacity of the aqueous humour (McDonald and Shadduck method) was also assessed for potential epithelial damage.

Results

Effects on conjunctivae in terms of chemosis and redness were noted in rabbits. However, slight reactions of the mucous membranes were fully reversible within 7 d. Test substance was not irritant to rabbit eye.