Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Sepisol fast Blue 85219
- Substance type: organic salt - UVCB
- Appearance/Physical state: dark blue powder
- Stability under test conditions: stable
- Storage condition of test material:room temperature
Specific details on test material used for the study:
- Batch N° 310551

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage GRIMAUD, 49459, FRANCE
- Age at study initiation:
- Weight at study initiation: 2.710 kg the day of the test material application
- Housing: inox cage with one animal per cage (60cm x 45 cm x 32 cm)
- Diet: granules Starlap Unic Robe
- Water : ad libitum
- Acclimation period: 5 days at least

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 50 +/- 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs/1 2 hrs

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,1 g
Duration of treatment / exposure:
single exposure followed by contention period of one hour
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
1 animal.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: according to OECE 405

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritant / corrosive response data:
The test item leads to a reversible irritation
Other effects:
From day 2 up to day 9, opacity is visible without any devices

Any other information on results incl. tables

Scores

Chemosis

Chemosis Score

for Animal 1      

                                Observation period (after application)            

 1h

 24h

 48h

 72h

 Mean*

 Day 5

Day 6

Day 7 

 Day 8

 Day 9

 Day 10

 Day 11

 Day 12  Day 13 Day 14  Day 15upto21 

 3

 3

 3

 2

 2.7

 2

 2

 2

1

 1

 1

 1

 1  1  0

Redness

Redness Score

for Animal 1     

                                Observation period (after application)            

 1h

 24h

 48h

 72h

 Mean*

 Day 5

Day 6

Day 7 

 Day 8

 Day 9

 Day 10

 Day 11

 Day 12  Day 13 Day 14  Day 15upto21 

 3

 3

 3

 3

 3

 3

 3

 2

1

 1

 1

 1

 1  1  0

Iris

Iris Score

for Animal 1     

                                Observation period (after application)            

 1h

 24h

 48h

 72h

 Mean*

 Day 5

Day 6

Day 7 

 Day 8

 Day 9

 Day 10

 Day 11

 Day 12  Day 13 Day 14  Day 15upto21 

 1

 1

 1

 1

 1

 1

 1

 1

1

 1

 0

 0

 0  0  0

Cornea

Cornea Score

for Animal 1     

                                Observation period (after application)            

 1h

 24h

 48h

 72h

 Mean*

 Day 5

Day 6

Day 7 

 Day 8

 Day 9

 Day 10

 Day 11

 Day 12  Day 13 Day 14  Day15upto21 

 0

 2

 2

 2

 2.0

 2

 2

 2

2

 2

 2

 1

 1  1  0

* mean for the1h, 24h, 48h and 72 h periods

/: no observation performed

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Under the experimental conditions, the test item is classified as irritant category 2 according to the CLP regulation (EC 1272/2008).
Executive summary:

The aim of this study was to assess qualitatively and quantitatively irritancy or corrosion and the delay of appearance of the effects after single application of 0,1 g of the pure test material named SEPISOL FAST BLUE 85219 as supplied on eye in one rabbit.

The assay was performed according to the OCDE guideline n° 405.

The ocular reactions (redness and chemosis of conjunctivae, iris and cornea lesions) were scored 1h, 24h, 48h and 72 h after application and until complete reversibility of the effects (D14). The untreated eye served as control.

The test element was classified in accordance with the criteria defined in the decree of 20/04/1994 taken in enforcement from the basic Directive 67/548/EEC of the Official Journal of European Communities of June 27, and its successive amendments.

The study was performed from 2008/03/17 to 2008/03/30.

The results for the mean score were as follows (mean score 24h, 48h and 72h after application): chemosis: 2.7; redness: 3.0; Iris:1.0; Cornea: 2.0.

The test element was classified among the chemicals irritating to eyes (R36).