Bis[N-(4-{[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-ethylethanaminium] [mono and bis(dodecanyl, branched)]-(sulfonatophenoxy) benzenesulfonate

Eye irritation

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

tetrakis(4-{[4-(diethylamino)phenyl][4-(ethylamino)naphthalen-1-yl]methylidene}-N,N-diethylcyclohexa-2,5-dien-1-iminium) 2-(dodecan-5-yl)-4-(4-sulfonatophenoxy)benzene-1-sulfonate 2-(dodecan-5-yl)-4-[3-(dodecan-5-yl)-4-sulfonatophenoxy]benzene-1-sulfonate

EC Number:

700-579-6

Molecular formula:

C90H114O7S2N6 (MW = 1454) and C102H138O7S2N6 (MW = 1622)

IUPAC Name:

tetrakis(4-{[4-(diethylamino)phenyl][4-(ethylamino)naphthalen-1-yl]methylidene}-N,N-diethylcyclohexa-2,5-dien-1-iminium) 2-(dodecan-5-yl)-4-(4-sulfonatophenoxy)benzene-1-sulfonate 2-(dodecan-5-yl)-4-[3-(dodecan-5-yl)-4-sulfonatophenoxy]benzene-1-sulfonate

Test material form:

solid: particulate/powder

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

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible

Results 2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 4

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).