Reaction mass of lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate and lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-{[4-(vinylsulfonyl)phenyl]diazenyl}naphthalene-2,7-disulfonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate

EC Number:

401-560-2

EC Name:

Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate

Cas Number:

108624-00-6

Molecular formula:

C28H(21-x-y)ClF2Li(x)N8Na(y)O16S5

IUPAC Name:

Lithium sodium hydrogen-4-amino-6-(5-(5-chloro-2,6-difluoropyrimidine-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Blue FC 05717

Test animals / tissue source

Species:

rabbit

Strain:

other: HC: NZW

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd
- Weight at study initiation: 3.1 - 3.7 kg
- Housing: individual mesh cages, Type III
- Diet (e.g. ad libitum): ssniff K4, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye

Amount / concentration applied:

40 mg in 100 µL

Duration of treatment / exposure:

Duration of exposure was 24 h. The treated eye was rinsed with saline solution at the end of the exposure period.

Observation period (in vivo):

1, 24, 48 , 72 h and after 7, 14 and 21 d following administration of the test substance.

Number of animals or in vitro replicates:

3 females

Details on study design:

TEST PROCEDURE

40 mg of the test substance was administered once to the conjunctival sac of the left eye of the rabbits in 100 µL solution. In each case the untreated eye served as a control. 24 h after administration, the treated eye was washed out thoroughly with saline solution.

The eyes were examined 1, 24, 48 , 72 h and after 7, 14 and 21 d following administration of the test substance for effects on the cornea, iris and conjunctiva. Scoring was done according to the Draize scale. Tear production and any effects not covered by the Draize scale were also recorded.

In case of positive findings in the iris and cornea at 24 h and at later evaluation points, one drop of a 1% fluorescein solution was applied to the corneal surfaces, then washed out with saline solution. The eyes were thereafter analysed with UV light.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Remarks:

(mean score)

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Remarks:

(mean score)

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Remarks:

(mean score)

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Slight redness or redness and swelling of the conjunctivae were seen in the rabbits in the first 24 h after administration of the test substance. These effects were linked to mechanical irritation.

Other effects:

Slight tear production was seen in one rabbit at the 24 h observation point.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test substance was not considered to be irritating to the rabbit eyes.

Executive summary:

A study was conducted to assess the eye irritation potential of the test substance in one New Zealand albino female rabbit according to OECD Guideline 405, in compliance with GLP. A single dose of 40 mg test substance was applied to the conjunctival sac of the left eye of the animal in 100 µL solution. The treated eye was washed at 24 h after administration. The untreated eye served as a control. The eyes were examined 1, 24, 48 , 72 h and after 7, 14 and 21 d following administration of the test substance for effects on the cornea, iris and conjunctiva. Scoring was done according to the Draize scale. Tear production and any effects not covered by the Draize scale were also recorded. Slight redness or redness and swelling of the conjunctivae were seen in the rabbits in the first 24 h after administration of the test substance. One rabbit showed light tear production at 24 h. These effects were linked to mechanical irritation and were reversible before end of the study. Under the test conditions, the test substance was not considered to be irritating to the rabbit eyes (Ruf, 1987b).