2-Naphthalenesulfonic acid, 4-hydroxy-3-[2-[2-methoxy-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-7-[(sulfomethyl)amino]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:5)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Apr. 19, 2005 to May 10, 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

464-700-1

EC Name:

-

Cas Number:

607724-42-5

Molecular formula:

Hill formula: C28H24N5Na5O23S7 CAS formula: C28H29N5O23S7.5Na

IUPAC Name:

pentasodium 4-hydroxy-3-(2-{2-methoxy-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-8-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-7-[(sulfonatomethyl)amino]naphthalene-2-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Red F01-0481

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kißlegg
- Weight at study initiation: 3.63 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3°C
- Humidity: 50 ± 20 %
- Air changes:

IN-LIFE DATES: From: Apr. 19, 2005 To: May 10, 2005

Test system

Vehicle:

not specified

Remarks:

No vehicle used

Controls:

other: the untreated right eye served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount applied : 0.1 g

Duration of treatment / exposure:

24 h

Observation period (in vivo):

21 d

Number of animals or in vitro replicates:

1

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: 24 h after start of exposure with isotonic saline at approx. 37 °C

SCORING SYSTEM: as per OECD Guideline

TOOL USED TO ASSESS SCORE: fluorescein and UV light

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Irritant / corrosive response data:

From 1 h up to 72 h after administration the conjunctiva showed definitely injected blood vessels up to a crimson red color and up to 24 h after treatment some swelling above normal up to obvious swelling with partial eversion of lids. 24 h after application the nictitating membrane of the animal was discolored by the test item up to the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the substance caused discoloration of the nictitating membrane of rabbit eye until end of the study period. No other signs of irritation were observed.

Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance in one NZW White rabbit according to OECD Guideline 405 and EU Method B.5, in compliance with GLP.

A single dose of 100 mg test substance was applied to the conjunctival sac of the left eye of the animal. The treated eye was washed out 24 h after administration. The untreated eye served as a control.

Overall mean scores for eye irritation were calculated to be 0.0 for iris and opacity of cornea, 1.33 for redness of conjunctiva and 0.33 for chemosis of conjunctiva. 24 h after the application, the nictitating membrane was discoloured by the test substance up to the end of the study. No clinical signs of systemic toxicity were seen. Body weight gain of the treated animal was not affected.

Due to the fact that a classification of R41 under DSD/DPD was warranted due to the non-reversible discolouration of the nictitating membrane, no further animals were tested due to animal welfare reasons. However, as only the conjunctivae of the rabbit eye were discoloured. And no other signs of eye irritation were found, following the criteria of Regulation (EU) 1272/2008, no classification applies in terms of serious eye irritation/eye damage.