Sodium 2-[[4-(cyclohexylamino)-9,10-dihydro-9,10-dioxo-1-anthryl]amino]-5-ethoxybenzenesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Remarks:

source of read across

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

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)

Version / remarks:

May 12, 1981

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 02

IUPAC Name:

Similar Substance 02

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 / Switzerland.
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.4 - 2.9 kg.
- Housing: individually in stainless steel cages equipped with a automatic cleaning and drinking system.
- Diet: pelleted standand KIiba 341, Batch 94/84 rabbit maintenance diet ("KIiba", Klingentalmuehle AG, Switzerland), ad libitum.
- Water: community tap water from Itigen, ad libitum.
- Acclimation period: four days under Iaboratory conditions, after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Air changes: 15 air changes per hr.
- Photoperiod: 12 hrs dark / 12 hrs light.
- Other: at least 8 hours music/light period.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

A single dose was administrated to the left eye of each animal. The individual dose volume was 0.1 g per animal.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

1 male and 2 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: eyes were not rinsed.

OBSERVATIONS
- Viability/mortality: daily.
- Body weight: pre-test, day 1 and at termination of test on Mettler PK 16 balance.

SCORING SYSTEM
The eyes of each animal were examined 1, 24, 48, 72 hours and 7 days after administration. The irritation was assessed according to the OECD guideline for testing of Chemicals, Section 4, number 405 "Acute Eye Irritation/Corrosion" adopted May 12, 1981.
The corrosive properties of the test article and the color of the treated eye were described and recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 1

Reversibility:

fully reversible within: 48 hrs

Results 2

Irritation parameter:

iris score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 1

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2

Reversibility:

fully reversible within: 72 hrs

Irritant / corrosive response data:

Under the conditions of the experiment, the test item was found to cause a primary irritation score of 2.2 when applied to the rabbit eye mucosa.
In the area of application a bluish dicoloration of the conjunctivae was observed within 1 hour after treatment; this could be related to effects of the test article.
No corrosion was observed at each of the measuring intervals.

Other effects:

TOXIC SYMPTOMS/MORTALITY
No acute toxic symptoms were observed in the animlas during the test period and no mortality occurred.

BODY WEIGHT
The body weight gain of all rabbits was similar.

Any other information on results incl. tables

Eye irritation score

Animal N.	Reaction	After					Mean 24/48/72 hrs
		1 hr	24 hrs	48 hrs	72 hrs	7 days
320 M	Cornea opacity	1	1	0	0	0	0.33
321 F	Cornea opacity	0	0	0	0	0	0.00
322 F	Cornea opacity	0	0	0	0	0	0.00
320 M	Iris	0	0	0	0	0	0.00
321 F	Iris	0	0	0	0	0	0.00
322 F	Iris	0	0	0	0	0	0.00
320 M	Conjuntivae redness	1	2	2	1	0	1.67
321 F	Conjuntivae redness	1	1	1	1	0	1.00
322 F	Conjuntivae redness	1	1	1	1	0	1.00
320 M	Conjunctivae chemosis	2	2	1	0	0	1.00
321 F	Conjunctivae chemosis	2	1	0	0	0	0.33
322 F	Conjunctivae chemosis	2	1	0	0	0	0.33

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Not irritating

Executive summary:

Three rabbits were used to test the eye irritation potential of the substance, in accordance with OECD guideline 405. 0.1 g of the undiluted test material were placed into the conjunctival sac. The eyes of each animal were examined 1, 24, 48, 72 hours and 7 days after administration. Reading scores for ocular lesions were made according to the OECD guideline for testing of Chemicals, Section 4, number 405 "Acute Eye Irritation/Corrosion" adopted May 12, 1981.

Under the conditions of the experiment, the test item was found to cause a primary irritation score of 2.2 when applied to the rabbit eye mucosa. In the area of application a bluish dicoloration of the conjunctivae was observed within 1 hour after treatment; this could be related to effects of the test article. No corrosion was observed at each of the measuring intervals.

Conclusion

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and chemosis, in all the tested animals. All the reactions were fully reversible.

Thus, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC 1272/2008).