Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
October 19th, 1993 to October 29th, 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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
EEC Directive 8.5. 'Acute toxicity Eye Irritation' of the Directive 84/449/EEC: Commission Directive of 25 April 1984 adapting to technical progress for the sixth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
OECD Guidelines for Testing of Chemicals, 405 "Acute Eye Irritation/Corrosion", OECD 1981 Updated Guideline, adopted: 24th February 1987
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reaction product of 3,9-dibromobenzanthrone condensed with 2 equivalents of 1-aminoanthraquinone, subsequently further condensed under oxidative conditions
EC Number:
944-232-9
Molecular formula:
Not available - UVCB substance
IUPAC Name:
Reaction product of 3,9-dibromobenzanthrone condensed with 2 equivalents of 1-aminoanthraquinone, subsequently further condensed under oxidative conditions
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 species: New Zealand albino rabbit
Strain: Chbb: NZW (SPF)
Origin: Chemisch pharmazeutische Fabrik Dr. K. Thomae, 88400 Biberach
Number of animals: 3Animal identification: numbered ear tags
Animal weights: 2.8 - 3.7 kgAge of animals: about 3 - 5 months
Animal housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
Ambient temperature: 18 ± 3 °CRelative humidity: 50 ± 20 %
Lighting time: 12 hours per day
Diet: Altromin 2123 maintenance diet – rabbits (Altromin GmbH, Lage/Lippe), ad libitum and hay (approx. 15 g daily)
Drinking water: deionised, chlorinated water from automatic water dispensers, ad libitum

Test system

Vehicle:
not specified
Controls:
other: Untreated eyes acted as controls
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Single exposure, 24 hour treatment period
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 animals
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 lndanthren-Oliv HT Colloisol 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 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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
One hour p.a. the conjunctiva of the animals showed slight to obvious swelling with partial eversion of lids as well as up to 24 hours p.a. evident hyperaemie to diffuse deeper crimson coloured reddenings.48 hours p.a. the irritations were reversible.
Other effects:
Additional a clear from the substance discoloured discharge was observed.

Any other information on results incl. tables

RABBIT EYE IRRITATION TEST - READINGS

Animal Number

Sex

Eye Used

Initial Pain Reaction

Irrigation

Elapsed Time

CORNEA

IRIS

CONJUNCTIVAE

OPACITY

AREA

REDNESS

CHEMOSIS

DISCHARGE

55

F

LEFT

NONE

24 HRS

1.0   HRS

1 DAY

2 DAYS

3 DAYS

0

0

0

0

0

0

0

0

0

0

0

0

2

1

0

0

2

0

0

0

1

0

0

0

90

F

LEFT

NONE

24 HRS

1.0 HRS

1 DAY

2 DAYS

3 DAYS

0

0

0

0

0

0

0

0

0

0

0

0

1

1

0

0

1

0

0

0

2

0

0

0

92

F

LEFT

NONE

24 HRS

1.0 HRS

1 DAY

2 DAYS

3 DAYS

0

0

0

0

0

0

0

0

0

0

0

0

2

0

0

0

1

0

0

0

2

0

0

0

 

 

ADDITIONAL INFORMATION

S = slight

X = finding present

M = moderate

N = previous finding reversible

E = extreme

? = not assessable

 

Animal Number

Clinical Observation

Dosed Eye

Time After Dosing

1 HR

1 DAY

2 DAYS

3 DAYS

55

Eye Disch. Clear, Subst. Col

No Abnormalities Detected

Killed at End of Study

X

N

 

N

 

 X

Animal Number

Clinical Observation

Control Eye

Time After Dosing

1 HR

1 DAY

2 DAYS

3 DAYS

55

No Abnormalities Detected

N

N

N

N

INITIAL BODYWEIGHT: 2790.0 g

FLUORESCEIN STAINING: Time after dosing:       1 Day 0

                                                              3 Days 0

EYE TEXT: No Text Recorded

COMMENTS: No Commented Recorded

 

Animal Number

Clinical Observation

Dosed Eye

Time After Dosing

1 HR

1 DAY

2 DAYS

3 DAYS

90

Eye Disch. Clear, Subst. Col

No Abnormalities Detected

Killed at End of Study

X

N

 

N

 

 X

Animal Number

Clinical Observation

Control Eye

Time After Dosing

1 HR

1 DAY

2 DAYS

3 DAYS

90

No Abnormalities Detected

N

N

N

N

INITIAL BODYWEIGHT: 3740.0 g

FLUORESCEIN STAINING: Time after dosing:       1 Day 0

                                                              3 Days 0

EYE TEXT: No Text Recorded

COMMENTS: No Commented Recorded

 

Animal Number

Clinical Observation

Dosed Eye

Time After Dosing

1 HR

1 DAY

2 DAYS

3 DAYS

92

Eye Disch. Clear, Subst. Col

No Abnormalities Detected

Killed at End of Study

X

N

 

N

 

 X

Animal Number

Clinical Observation

Control Eye

Time After Dosing

1 HR

1 DAY

2 DAYS

3 DAYS

92

No Abnormalities Detected

N

N

N

N

INITIAL BODYWEIGHT: 3360.0 g

FLUORESCEIN STAINING: Time after dosing:       1 Day 0

                                                              3 Days 0

EYE TEXT: No Text Recorded

COMMENTS: No Commented Recorded

 

RABBIT EYE IRRITATION TEST - ANALYSIS

 

MEAN SCORE (1 DAY – 3 DAYS AFTER DOSING)

ANIMAL NUMBER

CORNEA

IRIS

CONJUNCTIVA

OPACITY

REDNESS

CHEMOSIS

55

0.00

0.00

0.33

0.00

90

0.00

0.00

0.33

0.00

92

0.00

0.00

0.00

0.00

GROUP MEAN SCORE

0.00

0.00

0.22

0.00

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Testing of Indanthren-Oliv HT Colloisol 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 application of the test substance to the conjunctival sac of the eye and serves as a basis for classification and labelling.

 

The study was conducted in compliance with:

EEC Directive 8.5. 'Acute toxicity Eye Irritation' of the Directive 84/449/EEC: Commission Directive of 25 April 1984 adapting to technical progress for the sixth time. Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances

OECD Guidelines for Testing of Chemicals, 405 "Acute Eye Irritation/Corrosion", OECD 1981 Updated Guideline, adopted: 24th February 1987

 

Testing of Indanthren-Oliv HT Colloisol for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.