Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid monosodium salt

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:

Source study has reliability 2. Details on the read across are attached in section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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: Dr. K. Thomae GMBH; Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- Weight at study initiation: 2230 to 2620 g
- Housing: individually
- Diet: ad libitum standard rabbit pellet
- Water: fresh water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (32 mg) of test substance were applied into the conjunctival sac of the left eye of each animal.
- The right eye remained untreated and served as control

Duration of treatment / exposure:

After instillation the lids were held together for about one second to prevent loss of test article.

Observation period (in vivo):

Ocular reactions were evaluated after 1, 24, 48 and 72 hours after instillation
Reaction was observed after 7, 10 and 14 days of instillation

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM:
Cornea
A. Opacity-degree of density
0 No opacitiy
1 Scaterred or difussed area, details of iris clearly visible
2 Easily discernible translucent areas, details of iris slightly obscured
3 Opalescent areas, no details of iris visible
4 Opaque, iris invisible

B. Area of cornea involved
1 One quarter (or less) but not zero
2 Greater than one quarter, but less than half
3 Greater than half, but less than three quarters
4 Greater than three quarters, up to whole area

A×B×5 Total maximum = 80

Iris
A. Values
0 Normal
1 Folds above normal, congestion, swelling, circumcorneal injection
2 No reaction to light, hemorrhage, gross destruction

A×5 Total maximum=10

Conjuctivae
A. Redness
0 Vessels normal
1 Vessels definitely injected above normal
2 More diffuse, deeper crimson red, individual vessels not easily discernible
3 Diffuse beefy red

B. Chemosis
0 No swelling
1 Any swelling above normal
2 Obvious swelling with partial eversion of lids
3 Swelling with lids about half closed
4 Swelling with lids about half closed to completely closed

C. Discharge
0 No discharge
1 Any amount different from normal
2 Discharge with moistening of the lids and hairs just adjacent to lids
3 Discharge with moistening of the lids and hairs, and considerable area around the eye

(A+B+C)×2 Total maximum=20

TOOL USED TO ASSESS SCORE: slit-lamp was used to facilitate the evaluation

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

658/F

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

658/F

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Remarks:

658/F

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

658/F

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

110/F

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

110/F

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Remarks:

110/F

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

110/F

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

098/F

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

098/F

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 11

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Remarks:

098/F

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

098/F

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 14 days

Any other information on results incl. tables

Results tabulated

 

3 animals or less	mean score animal (1 / 2 / 3)			maximum value	maximum duration of any effect	maximum value at the end of the observation period
conjunctiva/redness	1	2	1	2	10 days	0
conjunctiva/chemosis	0.33	0.33	0	1	24 hours	0
cornea	0.33	0.67	0.33	1	48 hours	0
iris	0	0.33	0	1	24 hours	0

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The substance was tested according to the guidelines OECD 405.
Based on scores at 24 to 72 hours after instillation of the substance, the substance resulted as not irritant to rabbit eye. Changes were fully reversible within 14 days.

Executive summary:

Method

Eye irritation potential was assessed following OECD guideline 405. Test substance was applied to one eye of 3 rabbits; the other eye served as control. No indication of eye rinse was reported. Observations were done at 1, 24, 48 and 72 h and 7d, 10 d and 14 after application. Effects on cornea, iris and conjunctivae were noted.

Results

Test material induced reactions of cornea, iris and conjunctiva when instilled into the conjunctival sac of rabbits eyes.

The following mean scores over the period from 24 to 72 h were calculated:

animal no.	658	110	98
conj. redness	1	2	1
conj. chemosis	0.33	0.33	0
cornea	0.33	0.67	0.33
iris	0	0.33	0

Effects were fully reversible within the 14 days observation period.