tetrakis[({bis[4-(dimethylamino)phenyl] and 4-(methylamino)phenyl} or {4-(dimethylamino)phenyl and bis[4-(methylamino)phenyl]} or {tris[4-(dimethylamino)phenyl]}methylium)]C12-(branched and/or linear)-alkyl-(4-sulfonatophenoxy)benzenesulfonate and oxybis[C12-(branched and/or linear)-alkyl-benzenesulfonate].

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2008-03-17 to 2008-04-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The reliability is rated 1 because the study followed the standard guideline of reference (OECD 405), which describes a procedure designed to evaluate this endpoint, the results were reviewed for reliability and assessed as valid, and the study was conducted under GLP condition.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

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:

bis(bis[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylium) bis(tris[4-(dimethylamino)phenyl]methylium) 3-(dodecan-3-yl)-4-(2-dodecyl-4-sulfonatophenoxy)benzene-1-sulfonate 3-dodecyl-4-(4-sulfonatophenoxy)benzene-1-sulfonate

EC Number:

700-759-4

Molecular formula:

not applicable

IUPAC Name:

bis(bis[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylium) bis(tris[4-(dimethylamino)phenyl]methylium) 3-(dodecan-3-yl)-4-(2-dodecyl-4-sulfonatophenoxy)benzene-1-sulfonate 3-dodecyl-4-(4-sulfonatophenoxy)benzene-1-sulfonate

Details on test material:

- Name of test material : Sepisol Fast Violet 881239
- Substance type : organic salt - UVCB
- Physical state/ appearance: violet powder
- Lot/batch No.: 601204
- Storage condition of test material: ambient temperature and in the dark

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
- Weight at study initiation: 2.8 kg the day of the test material application
- Housing: Singly housed, in suspended stainless steel cage (60cm x 45 cm x 32 cm)
- Diet: granules Starlap Unic Robe (EVIALIS, 37018 Tours, France)
- 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/12 hrs

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye of the animal serves as control

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):

21 days

Number of animals or in vitro replicates:

1 animal.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No removal by washing

SCORING SYSTEM: according to OECD 405

TOOL USED TO ASSESS SCORE: macroscopic examination and examination with fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean score: 24,48 and 72h after application

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Results 2

Irritation parameter:

other: Redness

Basis:

animal #1

Time point:

other: mean score: 24,48 and 72h after application

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 21 days

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean score: 24h, 48 and 72 h after application

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 21 days

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean score: 24h, 48h, 72h after application

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 21 days

Irritant / corrosive response data:

The test item leads to non-reversible eye damages

Any other information on results incl. tables

Scores

Chemosis

Chemosis Score for Animal# 2861	Observation Period (after application)
	1h	24h	48h	72h	Mean*	D5 to D9	D10 to D13	D14 to D20	D21
	3	4	4	4	4	4	3	2	1

Redness

Redness Score for Animal# 2861	Observation Period (after application)
	1h	24h	48h	72h	Mean*	D5 to D21
	3	3	3	3	3	3

Iris

Iris Score for Animal# 2861	Observation Period (after application)
	1h	24h	48h	72h	Mean*	D5 to D21
	1	1	1	1	1	1

Cornea

Cornea Score for Animal# 2861	Observation Period (after application)
	1h	24h	48h	72h	Mean*	D5 to D12	D13 to D14	D15 to D21
	0	2	2	2	2	2	3	2

* mean of observed values at 24, 48 and 72h after application

Clinical observations:

Time Reading	Comments
	Animal # 2861
Day 1 (first hour)	Nothing to report
Day 2 up to day 8	Edematous and burned nictitating membrane - Opacity visible to the naked eye - Alopecia
Day 9 up to Day 13	Edematous and burned nictitating membrane -  Opacity visible to the naked eye - Alopecia - Presence of a pannus - Presence of some pus (except on D12 and D13).
Day 14 up to Day 21	Slight burned nictitating membrane - Opacity visible to the naked eye - Alopecia - Presence of a pannus. Slight edematous cornea – Presence of some pus (except from D18 to D21)

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions, the test item is classified as irritant category 1 (R41) 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 Violet 881239 as supplied on eye in one rabbit. The assay was

performed according to the OEDC guideline n° 405.

Ocular reactions (redness and chemosis of conjunctivae, iris and cornea lesions) were scored 1h, 24h, 48h and 72 h after application and daily until the end of the study period (D21). The untreated eye served as control.

The results for the mean score were as follows (mean score 24h, 48h and 72h after application): chemosis: 4.0; redness: 3.0; Iris:1.0 and

Cornea: 2.0. In regards of the results observed and the irreversibility of the lesions at the end of the observation period on D21, the study was not carried out on 2 other rabbits for ethical reasons.

According to the criteria defined in the CLP regulation (EC 1272/2008), the test material is found to be classified as eye damage category 1.