1-Naphthalenesulfonic acid, 4-amino-, diazotized, coupled with diazotized 5(or 8)-amino-2-naphthalenesulfonic acid, diazotized 4-nitrobenzenamine and resorcinol

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:

April, 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

study conducted on the analogue substance; the read across justification is detailed in section 13. The Reliability of the Source Study is 2.

Justification for type of information:

The read across justification is detailed in section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: REAL DECRETO 363/1995, 10 march

GLP compliance:

no

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: authorised supplier
- Weight at study initiation: 2099-2191 g
- Housing: stainless steel single cage
- Diet: daily dose of 150 g experimental diet for rabbits, provided by an authorised vendor
- Water: filtered tap water (5 µm), ad libitum
- Acclimation period: 7 days
- Health check: during observation period

ENVIRONMENTAL CONDITIONS
- Temperature: 21± 2 °C
- Humidity:55 ± 25 %
- Air changes: 15 air change per hour with filtered air (with 5 µm filter)
- Photoperiod: 12 hour cycle dark/light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3 males

Details on study design:

OBSERVATIONS: after 1, 24, 48, 72 hours and 7,14, and 21 days

SCORING SYSTEM: cornea, iris, conjunctiva (similar to OECD 405)
Cornea
Opacity: degree of density (readings should be taken from most dense area)*
No ulceration or opacity .............................................................................................................. 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible ................................................................................................................... 1
Easily discernible translucent area; details of iris slightly obscured ........................................... 2
Nacrous area; no details of iris visible; size of pupil barely discernible ..................................... 3
Opaque cornea; iris not discernible through the opacity ............................................................. 4
Maximum possible: 4
* The area of corneal opacity should be noted Iris

Iris
Normal......................................................................................................................................... 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (a sluggish reaction is considered to be an effect.................... 1
Hemorrhage, gross destruction, or no reaction to light ............................................................... 2
Maximum possible: 2

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris) Normal......................................................................................................................................... 0
Some blood vessels hyperaemic (injected) ................................................................................. 1
Diffuse,crimson colour; individual vessels not easily discernible............................................... 2
Diffuse beefy red ......................................................................................................................... 3
Maximum possible: 3

Chemosis
Swelling (refers to lids and/or nictating membranes)
Normal......................................................................................................................................... 0
Some swelling above normal....................................................................................................... 1
Obvious swelling, with partial eversion of lids........................................................................... 2
Swelling, with lids about half closed........................................................................................... 3
Swelling, with lids more than half closed.................................................................................... 4
Maximum possible: 4


TOOL USED TO ASSESS SCORE: fluorescein

To facilitate consideration of the reactions, the operator used a manual lamp. After 24 hours of application, fluorescein was usedto evaluate any lesions.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Any other information on results incl. tables

Table 1: eye irritation scores

	1hour	24 hours	48 hours	72 hours	7 days	14 days	21 days
animal #1
corneal opacity	-	1	1	1	0	0
iritis	-	1	1	1	0	0
conjunctival redness	-	3	2	2	1	0
conjunctival oedema (chemosis)	3	3	2	2	0	0
animal #2
corneal opacity	-	1	1	1	0	0
iritis	-	1	1	1	0	0
conjunctival redness	-	3	2	2	1	0
conjunctival oedema (chemosis)	3	4	3	3	0	0
animal #3
corneal opacity	-	1	1	1	0	0
iritis	-	1	1	1	0	0
conjunctival redness	-	3	3	2	1	0
conjunctival oedema (chemosis)	3	4	3	2	0	0

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 (eye irritant) according to the CLP Regulation (EC) No. 1272/08

Conclusions:

The test item was found to be irritating when applied to the rabbit eye.

Executive summary:

The potential for the test item to induce eye irritation or serious damage was evaluated in an experimental study, according to a method similar to the OECD Guideline 405. Three male rabbits were administered 100 mg of unchanged test item to one eye for a duration of 24 hours; the untreated eye served as a negative control. Corneal opacity, iritis, conjunctival redness and chemosis were evaluated 1, 24, 48 and 72 hours and 7, 14 and 21 days after application of the test item.

The cornea and iris scores (mean values 24/48/72) were 1 in all animals. The mean values 24/48/72 h for conjunctivae for redness were 2.33 in two animals (#1 and #2) and 2.67 in one animal (#3); for chemosis were 2.33 in animal #1, 3.33 in animal #2 and 3 in animal #3. All effects observed were fully reversible within the 21-day observation period.