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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:
other: Study conducted to recent EU & OECD test guidance in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Reaktiv-Orange DYPR 1410
- Physical state: Orange powder
- Analytical purity: 73%
- Purity test date: December 15, 1998
- Lot/batch No.: DYPR 1410
- Expiration date of the lot/batch: August 2003
- Storage condition of test material: darkness at approximately 5 deg C in a refrigerator

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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean score
Time point:
other: Overall 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean score
Time point:
other: Overall 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Remarks:
mean score
Time point:
other: Overall 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score
Time point:
other: Overall 24, 48, 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean score
Time point:
other: overall 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean score
Time point:
other: overall 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Remarks:
mean score
Time point:
other: overall 24, 48, 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score
Time point:
other: overall 24, 48, 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean score
Time point:
other: overall 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean score
Time point:
other: overall 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Remarks:
mean score
Time point:
other: overall 24, 48 , 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean score
Time point:
other: overall 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
72 hours after administration all signs of irritating were reversible.
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.