1H-Benz[e]indolium, 2-[2-[2-chloro-3-[2-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2H-benz[e]indol-2-ylidene]ethylidene]-1-cyclohexen-1-yl]ethenyl]-1,1-dimethyl-3-(4-sulfobutyl)-, inner salt, ammonium salt (1:1)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF, 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-[(1E)-2-[(3Z)-2-chloro-3-{2-[(2E)-1,1-dimethyl-3-(4-sulfobutyl)-1H,2H,3H-benzo[e]indol-2-ylidene]ethylidene}cyclohex-1-en-1-yl]ethenyl]-1,1-dimethyl-3-(4-sulfonatobutyl)-1H-benzo[e]indol-3-ium amine

EC Number:

700-626-0

Cas Number:

1073607-50-7

Molecular formula:

C46 H50 Cl N2 O6 S2 . H4 N

IUPAC Name:

2-[(1E)-2-[(3Z)-2-chloro-3-{2-[(2E)-1,1-dimethyl-3-(4-sulfobutyl)-1H,2H,3H-benzo[e]indol-2-ylidene]ethylidene}cyclohex-1-en-1-yl]ethenyl]-1,1-dimethyl-3-(4-sulfonatobutyl)-1H-benzo[e]indol-3-ium amine

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated/other eye served as the reference control.

Amount / concentration applied:

33mg

Observation period (in vivo):

1, 24, 48 and 72 hours after dosing

Number of animals or in vitro replicates:

3 males

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: The corneal injury consisted of opacity (maximum grade 1 at 1 hour after dosing). Slight dulling of the normal luster of the cornea was also observed in one animal

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Iridial irritation grade 1 was observed in two animals.

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

>= 0 - <= 1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: The irritation of the conjunctivae consisted of redness, chemosis and discharge.

Other effects:

Corrosion: There was no evidence of ocular corrosion.
Coloration/remnants: Remnants of the test substance were present in the eye on Day 1. Green staining of the fur on the head and paws, caused by the test substance, was noted during the observation period.
Toxicity/mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: GHS of the United Nations, EC No 1272/2008 and Directive 67/548/EEC