5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid

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:

other: data from peer reveiwed 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:

Eye irritation of chemical tartrazine was conducted on rabbits.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

217-699-5

EC Name:

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

Cas Number:

1934-21-0

IUPAC Name:

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

Constituent 2

Reference substance name:

Tartrazine

IUPAC Name:

Tartrazine

Details on test material:

- Name of test material (as cited in study report): Tartrazine
- Molecular formula (if other than submission substance): C16-H12-N4-O9-S2.3Na
- Molecular weight (if other than submission substance): 534.3681
- Substance type: Organic

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Details on test animal
TEST ANIMALS
- Source: Summit View Farm, Hazelton, PA, USA
- Age at study initiation:
- Weight at study initiation: 3.0-3.5 kg,
- 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%
- Photoperiod (hrs dark / hrs light): 12-hr
light/dark cycle

Test system

Vehicle:

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

Controls:

yes, concurrent vehicle

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.

Number of animals or in vitro replicates:

6 female and 6 male New Zealand White rabbits

Details on study design:

Details on study design
TEST SITE
- Area of exposure:Right eye of rabbit
- % coverage:
- Type of wrap if used:

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

SCORING SYSTEM:Draize procedure

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24

Remarks on result:

other: 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.

Irritant / corrosive response data:

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.

Other effects:

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

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

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.