REAKTIV-GELB F-68 072 FW

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 April 1993 to 25 May 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

lithium sodium 2-amino-4-{[4-(cyanoazanidyl)-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl]amino}-5-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonate

EC Number:

413-090-5

Cas Number:

189574-45-6

Molecular formula:

Hill formula: C24H18LixN10NayO12S4

IUPAC Name:

lithium sodium 2-amino-4-{[4-(cyanoazanidyl)-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl]amino}-5-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

See below

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test species: New Zealand albino rabbit
Strain: Chbb: NZW (SPF)
Origin: Chemisch pharmazeutische Fabrik Dr. K. Thomae, 7950 Biberach
Number of animals: 3
Animal identification: numbered ear tags
Animal weights: 3.8 - 3.9 kg
Age of animals: about 3 - 5 months
Animal housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
Ambient temperature: 18 ± 3 °C
Relative humidity: 55 ± 20 %
Lighting time: 12 hours per day
Diet: Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe), ad 1ibitum and hay (approx. 15 g daily)
Drinking water: deionised, chlorinated water from automatic water dispensers, ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

Exposure 24 hours

Observation period (in vivo):

72 hours - Effects were still present in the eyes after 72 hours, further examinations were carried out after 7 days.

Number of animals or in vitro replicates:

3

Details on study design:

About 24 hours before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01 % fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.

100 mg Reaktiv-Gelb F-68 072 FW was applied once to the conjunctival sac of the left eye of 3 rabbits. The untreated eyes served in each case as a control.

24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein-sodium solution took place, the treated eyes were washed out thoroughly with physiological saline at approx. 37 °C.

The eyes were examined 1, 24, 48 and 72 hours after application of the test substance. At 24 and 72 hours as well as after 7 days, the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded. Since effects were still present in the eyes after 72 hours, further examinations were carried out after 7 days.

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:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean score

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean score

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean score

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

One hour up to three days p.a. the conjunctivae of all animals showed deeper crimson red up to diffuse beefy red as well as slight swellings up to obvious swellings in two animals. One hour up to one day slight swellings up to obvious swellings were noted in one animal. Additionally clear, from substance discoloured discharge as well as white viscous discharge and bleeding at the nictating membrane were observed. 7 days p.a. all irritations were reversible.

Any other information on results incl. tables

RABBIT EYE IRRITATION TEST - READINGS

ANIMAL NUMBER	SEX	EYE USED	INIT PAIN REACTION	IRRIGAT’N	ELAPSED TIME	CORNEA		IRIS	CONJUNCTIVA
						OPACITY	AREA		REDNESS	CHEMOSIS	DISCHARGE
66	F	LEFT	NONE	24 HRS	1.2 HRS	0	0	0	3	2	2
					1 DAY	0	0	0	3	2	1
					2 DAYS	0	0	0	2	1	0
					3 DAYS	0	0	0	2	1	0
					7 DAYS	0	0	0	0	0	0
68	F	LEFT	VERY SEVERE	24 HRS	1.1 HRS	0	0	0	2	2	2
					1 DAY	0	0	0	3	1	0
					2 DAYS	0	0	0	2	0	0
					3 DAYS	0	0	0	2	0	0
					7 DAYS	0	0	0	0	0	0
72	F	LEFT	NONE	24 HRS	1.2 DAYS	0	0	0	3	2	2
					1 DAY	0	0	0	3	1	0
					2 DAYS	0	0	0	2	1	0
					3 DAYS	0	0	0	2	1	0
					7 DAYS	0	0	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Testing of Reaktiv-Gelb F-68 072 FW for primary eye irritation in the rabbit showed, that the substance is slightly irritating to eyes.

Executive summary:

Testing for primary irritation in the rabbit eye provides information on ocular lesions after a single application of the test substance to the conjunctival sac of the eye and serves as a basis for classification and labelling.

 

The present study was conducted in compliance with EEC Directive B.5. 'Acute toxicity Eye Irritation' of the Directive 84/449/EEC and OECD Guidelines for Testing of Chemicals, 405 "Acute Eye Irritation/Corrosion". This study was conducted in compliance with the Principles of Good Laboratory Practice (GLP).

 

One hour up to three days p.a. the conjunctivae of all animals showed deeper crimson red up to diffuse beefy red as well as slight swellings up to obvious swellings in two animals. One hour up to one day slight swellings up to obvious swellings were noted in one animal. Additionally clear, from substance discoloured discharge as well as white viscous discharge and bleddings at the nictating membran were observed.

 

7 days p.a. all irritations were reversible.

 

Testing of Reaktiv-Gelb F-68 072 FW for primary eye irritation in the rabbit showed, that the substance is slight irritating to eye. The substance is classified under CLP as "Eye Irritant, Cat 2", but does not fulfil the criteria for eye irritation under the Dangerous Substances Directive.