REACTIVE BLUE FC 75311

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 January 1995 to 24 January 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to recent EU and OECD test guidance. GLP is assumed, given the references and QA procedures, although is not specifically mentioned.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Remarks:

GLP is assumed, given the references and QA procedures, although is not specifically mentioned.

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

419-480-1

EC Name:

-

IUPAC Name:

Reaction mass of tetrasodium 2-((1-(3-(6-fluoro-(4-((N-(2-(2-sulfatoethanesulfonyl)ethyl)-N-phenyl)amino)-1,3,5-triazin-2-ylamino)-2-hydroxy-5-sulfonatophenylazo)-1-phenylmethyl)azo)-4-sulfonatobenzoate cuprate (4-) and trisodium 2-((1-(3-((4-(N-(2-ethenesulfonylethyl)-N-phenyl)amino)-6-fluoro-1,3,5-triazin-2-ylamino)-2-hydroxy-5-sulfonatophenylazo)-1-phenylmethyl)azo)-4-sulfonatobenzoate cuprate (4-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Reactive Blue FC 75311

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd
- Age at study initiation: Adult
- Weight at study initiation: Average weight 3.8 kg
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Standard diet, approx 100-120g per animal/day; once per day in the morning
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50 - 70
- Air changes (per hr): 12 -15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours, artifical illumination from 6am to 6pm

Test system

Vehicle:

not specified

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx 67mg (equivalent to 100 ul test substance)

Duration of treatment / exposure:

24 hours exposure

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

three

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Normal saline
- Time after start of exposure: 24 hoours

SCORING SYSTEM: DRAIZE

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: overall at 24, 48 72 hours

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: All animals showed mild effects up to 72 hours. No effects were noted at the end of the exposure period.

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: overall at 24, 48 and 72 hours.

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72

Remarks on result:

other: All animals showed mild effects up to 72 hours. No effects were noted at the end of the exposure period.

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: overall at 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: overall at 24, 48 and 72 hours

Score:

0

Max. score:

2

Irritant / corrosive response data:

Exposure of the test substance to the eye resulted in all three animals in transient slight conjunctival redness and discharge, and in one animal a very slight oedema was observed too (1 hour after the application). These signs of irritation had subsided in all animals by 72 hours. Cornea and iris showed no lesions or other signs of irritation. No ocular lesions and other signs of toxicity were not observed. This evidence indicates that the product may be considered as 'not irritating to the eye'.

Other effects:

Some discolouration occured in conjunctiva of all animals but not sufficient to affect the readings of reactions. Conjunctival swelling was noted in one animal and discharge from the eyes of all animals at the 1 hour reading. These were not noted in remaining assessments.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Substance is not irritating to the eye

Executive summary:

Study conducted to recent EU test guidance 92/69/EEC B5 & OECD 405.

The substance was found not irritating to the eye.