Reaction product of diazotised 2-amino-4,6-dinitrophenol coupled with resorcinol , subsequently coupled with diazotized 2-(4-aminophenylamino)-5-nitrobenzenesulfonic, chelated with iron, sodium potassium salts

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The test was conducted by means of Read Across approach. Further information was attached at section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC Directive 79/381, annex V, Part B

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Brown 360:1 - Similar Substance 01

IUPAC Name:

Acid Brown 360:1 - Similar Substance 01

Test material form:

not specified

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 I Switzerland
- Age at study initiation: l4 - 15 weeks
- Weight at study initiation: 2.5 - 2.8 Kg
- Housing: housed individually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet: The diet consisted of pelleted standard Kliba #341 rabbit maintenance diet, Batch 92/83 ad lihitum.
- Water: Tap water ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 - 15 air changes per hour.
- Photoperiod: 12 hour cycle dark/light with artificial fluorescent light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied : 0.1 g

Observation period (in vivo):

1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

2 male and 1 female

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: not rinsed eye

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: not rinsed eye

Results 3

Irritation parameter:

iris score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: not rinsed eye

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #1 and #3

Time point:

24/48/72 h

Score:

0.67

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: not rinsed eye

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: not rinsed eye

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible within: 48 hour

Remarks on result:

other: not rinsed eye

Results 7

Irritation parameter:

chemosis score

Basis:

animal: #2 and #3

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 72 hour

Remarks on result:

other: not rinsed eye

Other effects:

In the area of application a brown discoloration of the conjunctivae which could be related to effects of the teat article was observed during the observation period.

TOXIC SYMPTOMS / MORTALITY
No acute toxic aymptoma were observed in the animals during the teat period, and no mortality occurred.

NECROPSY
Due to the reaults obtained, no macroscopic organ examination was indicated.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

The substance is not irritating for rabbit eyes.

Executive summary:

The substance has been tested for eye irritation according to the OECD guideline 405 and EEC Directive 79/381, annex V, Part B. During the test 2 male and 1 female rabbits are treated with 0.1 g of the test compound.

Mean values at 24, 48 and 72 hours corneal opacity were 0.00 in two animals (#1 and #2) and 0.67 in one animal (#3). Mean values at 24, 48 and 72 hours for iris were 0.00 in all three animals. The conjunctivae scores as mean values at 24, 48 and 72 hours were: for redness 0.67 in animals #1 and #3 and 1 in animal #2; for chemosis 0.33 in animal #1 and 1 in animals #2 and #3. All effects observed were fully reversible within the end of the 72 -hour study period, except in one animal (animal #2 showed a redness score 1 at 72 hours). None of the treated eyes was rinsed after the test item application. Moreover, the substance is a powder and thus it is even more necessary to rinse the eye in order to exclude any effects that could occur due to its physical state. In addition, a fully reversibility was observed within 72 hours in all animals besides one animal (#2). Therefore, it is reasonable to expect that reversibility within 21 days will occur also in animal #2 even if it a fully reversibility was not possible to be observed within the 72 hours study period.