Disodium 4-hydroxynaphthalene-2,7-disulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journal.

Data source

Reference

Reference Type:

publication

Title:

EVALUATION OF THE CUMULATIVE (REPEATED APPLICATION) EYE IRRITATION AND CORNEAL STAINING POTENTIAL OF FD & C YELLOW NO. 5, FD &C BLUE NO. 1 AND FD&C BLUE NO. 1 ALUMINIUM LAKE

Author:

S. D. GETTINGS , D. L. BLASZCAK, M. T. RODDY, A. S. CURRy and G. N. McEwEN, JR

Year:

1992

Bibliographic source:

Fd Chem. Toxic. Vol. 30, No. 12, pp. 1051-1055, 1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To evaluate eye irritation potential of test chemical Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate conducted on rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate

Cas Number:

1934-21-0

Molecular formula:

C16H12N4O9-S2.3Na

IUPAC Name:

Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate

Details on test material:

IUPAC name: Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
Commen name:Tartrazine
Molecular weight :534.3681 g/mol
Molecular formula:C16H12N4O9-S2.3Na
Smiles:n1(c2ccc(cc2)S(=O)(=O)[O-])c(c(c(n1)C(=O)[O-])/N=N/c1ccc(cc1)S(=O)(=O)[O-])O.[Na+].[Na+].[Na+]
InChI:1S/C16H12N4O9S2.3Na/c21-15-13(18-17-9-1-5-11(6-2-9)30(24,25)26)14(16(22)23)19-20(15)10-3-7-12(8-4-10)31(27,28)29;;;/h1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);;;/q;3*+1/p-3/b18-17+;;
substance type: organic

Specific details on test material used for the study:

IUPAC name: Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
Commen name:Tartrazine
Molecular weight :534.3681 g/mol
Molecular formula:C16H12N4O9-S2.3Na
Smiles:n1(c2ccc(cc2)S(=O)(=O)[O-])c(c(c(n1)C(=O)[O-])/N=N/c1ccc(cc1)S(=O)(=O)[O-])O.[Na+].[Na+].[Na+]
InChI:1S/C16H12N4O9S2.3Na/c21-15-13(18-17-9-1-5-11(6-2-9)30(24,25)26)14(16(22)23)19-20(15)10-3-7-12(8-4-10)31(27,28)29;;;/h1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);;;/q;3*+1/p-3/b18-17+;;
substance type: organic

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Summit View Farm, Hazelton, PA, USA
- Age at study initiation:
- Weight at study initiation: 3.0-3.5 kg,
- Fasting period before study:
- Housing: Rabbits were individually housed in stainless steel, wire mesh-floor cages in a room
- Diet (e.g. ad libitum): feed (Certified Lab Rabbit Chow HF; Purina No. 5325) was limited to 125g/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: All animals were acclimatized for at least 2 wk prior to the start of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-21°C
- Humidity (%):38%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hr
light/dark cycle
New Zealand White rabbits male and female were used

Test system

Vehicle:

other: aqueous solution with 0.5 % (w/v) hydroxypropyl methylcellulose and 0.25 % (w/v) laureth-10 acetate)

Controls:

yes

Amount / concentration applied:

30 μl of test solution (3 % (w/v)

Duration of treatment / exposure:

1 application daily for 21 days

Observation period (in vivo):

Ophthalmic observations were conducted on days 3, 7 and 14 always prior to instillation.

Details on study design:

TEST SITE
- Area of exposure:Right eye of rabbit
SCORING SYSTEM:Modified Draize procedure

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

3

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

At ophthalmoscopic examinations, no ocular abnormities were noticed.

Other effects:

No lethality or significant clinical signs, and no substance-related weight change were observed.

Applicant's summary and conclusion

Interpretation of results:

other: Not eye irritant

Conclusions:

Not irritating effects were known in skin irritation of chemical tartrazine exposed to rabbit’s eye daily for 21 days.

Executive summary:

Eye irritation test was conducted on 6 female and 6 male New Zealand White rabbits.30 μl of test chemical in aq. solution was administered into the right eye of rabbits and left eyes served as untreated controls.

Ocular irritation was determined according to a modification of the Draize test. All animals were checked for viability twice daily.Ocular irritation was scored 24 h after each treatment and prior to the next instillation. On days 1, 3, 7, 14, and 21 the eyes were also evaluated 1 h after treatment. 24 h after each treatment

additionally eye stain and particle depositions were scored. Ophthalmic observations were conducted on days 3, 7 and 14 always prior to instillation.

No lethality or significant clinical signs, and no substance-related weight change were observed. Except slight conjunctival redness or discharge, that were seen sporadically in the eyes of the animals, all animals were free of significant signs of ocular irritation. No significant signs of eye staining or particle depositions were observed. At ophthalmoscopic examinations, no ocular abnormities were noticed.

Hence,tartrazine it is not expected to cause irritant effects following repeated treatment of eyes in a concentration of 3 % in aqueous solution.