Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-07-09 to 2008-10-15
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material: Reaction product of Acid Yellow 42, Acid Black 2 and Basic Violet 1
- Lot/batch No.: 2008041541
- Expiration date of the lot/batch: 2010-01-31
- Stability under test conditions: see expiry date
- Storage condition of test material: store cool and dry
- Analytical purity: 100 % (96.8 %; UVCB substance)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: TETRABBIT Kft.
2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: Young adult rabbit, 12 weeks old
- Weight at study initiation: beginning of the study: 3185-3223 g, end of the study: 3625-3697 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road,
Hungary, ad libitum.
- Water (e.g. ad libitum): tap water from municipal supply as for human consumption via automatic water system ad libitum
- Acclimation period: 11 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2-20.8 °C
- Humidity (%): 47-88%
- Air changes (per hr): 8-12 air exchange/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A total volume of 0.1 g of the test item was instilled into the conjunctival sac of the left eye.
Duration of treatment / exposure:
Single application. The eyes of test animals were washed out with physiological saline one hour after the test item application
Observation period (in vivo):
The eyes were examined at 60 minutes, 24, 48, 72 hours then one, two and three weeks after the treatment.
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of test animals were washed out with physiological saline
- Time after start of exposure: 1 hour

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: initial pain reaction (grade 1)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 hrs, 48 hrs, 72 hrs
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: area of 4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 week
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: area of 4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: initial pain reaction (grade 1)
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 hrs, 48 hrs, 72 hrs
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: area of 4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 week, 2 weeks, 3 weeks
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: area of 4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 hr, 24 hrs, 48 hrs, 72 hrs
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: area of 4, initial pain reaction (grade 1)
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 week, 2 weeks, 3 weeks
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: area of 4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 2 weeks, 3 weeks
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: area of 4

Any other information on results incl. tables

The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

Animal Number

Sex

Cornea Opacity

Iris

Conjunctivae

Redness

Chemosis

Discharge

8582

male

1.00

0.00

2.00

3.00

2.67

8181

male

1.00

0.00

1.33

3.00

2.67

8580

male

1.00

0.00

2.00

3.00

3.00

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item caused cornea opacity, irreversible within 21 days observation period.
Executive summary:

In the present study according to EU method B.5 and OECD guideline 405 the test substance F 46 Black caused cornea opacity, irreversible within 21 days observation period.