REAKTIV-ORANGE DYPR 1410

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 December 1998 to 11 December 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

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:

-

EC Number:

432-080-1

EC Name:

-

Molecular formula:

Hill formula: C18H15N3Na2O9S3 CAS formula: C18H17N3Na2O9S3.2Na

IUPAC Name:

Disodium 4-amino-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-1-sulfonate

Test material form:

solid: particulate/powder

Remarks:

microgranulate or well dedusted powder

Details on test material:

Name: Reaktiv-Orange DYPR 1410

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species: New Zealand albino rabbit
Origin: Charles River Deutschland GmbH 88353 KiSlegg
Number of animals: 3
Body weight at start of the study: 3.5-3.8 kg
Animal maintenance: in fully air-conditioned rooms in separate cages arranged in a battery
Room temperature: 20 ± 3°C
Relative humidity: 50 ± 20 %
Lighting time: 12 hours daily
Acclimatization: 1 week under study conditions
Food: ssniff® K-H (V2333), ad libitum and hay (approx. 15 g daily)
Water: water from automatic water dispensers, ad libitum
Animal identification: numbered ear tags

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg per eye

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

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-Orange DYPR 1410 was administered once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.

24 hours after administration 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 isotonic saline at approx. 37 °C.

The eyes were examined 1, 24, 48 and 72 hours after administration of the test sub¬stance. At 24 and 72 hours, the eyes were also examined for corneal lesions under UV light after instillation of one drop of a 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded.

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:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of weak irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

72 hours after administration all signs of possible irritation were reversed.

Other effects:

One hour up to 48 hours after administration the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse crimson red colour and very slight swellings. Additionally, reddish or substance coloured eye discharge was noted in two animals one hour after administration.

Any other information on results incl. tables

Generalised Results By Animal – Animals Against Parameters – Multiple Times

Activity: - Eye Irritation Results

Study: 98.0702 – Reaktiv-Orange DYPR 1410 – Eye Irritation Test in Rabbits

Group Sex	Animal No.	Day No	Time Slot	Opacity Grade	Opacity Area	Iris	Redness	Chemosis	Discharge
1f	71	1	1 hour after treatment	0	0	0	1	1	0
		2	24 hours after treatment	0	0	0	2	1	0
		3	48 hours after treatment	0	0	0	1	0	0
		4	72 hours after treatment	0	0	0	0	0	0
	72	1	1 hour after treatment	0	0	0	1	1	1
		2	24 hours after treatment	0	0	0	1	1	0
		3	48 hours after treatment	0	0	0	0	0	0
		4	72 hours after treatment	0	0	0	0	0	0
	79	1	1 hour after treatment	0	0	0	1	1	1
		2	24 hours after treatment	0	0	0	0	0	0
		3	48 hours after treatment	0	0	0	0	0	0
		4	72 hours after treatment	0	0	0	0	0	0

Nominal Dose: Group 1 – 100mg undiluted

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Testing of Reaktiv-Orange DYPR 1410 for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.

Executive summary:

Testing for primary irritation in the rabbit eye provides information on ocular lesions after a single administration 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-Guideline B.5."Acute Toxicity Eye Irritation" of the Directive 92/69/EEC and OECD Guidelines for Testing of Chemicals, 405 "Acute Eye Irritation / Corrosion". This study was conducted in compliance with GLP.

One hour up to 48 hours after administration the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse crimson red colour and very slight swellings. Additionally, reddish or substance coloured eye discharge was noted in two animals one hour after administration. 72 hours after administration all signs of irritating were reversible.

Testing of Reaktiv-Orange DYPR1410 for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.