Tetrasodium 7-[[4-[[4,6-bis[(3-sulfonatopropyl)thio]-1,3,5-triazin-2-yl]amino]-3-methoxyphenyl]azo]naphthalene-1,3-disulfonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 June 1998 to 27 June 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, perfomed in accordance with valid guidelines and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

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:

Tetrasodium 7-[[4-[[4,6-bis[(3-sulfonatopropyl)thio]-1,3,5-triazin-2-yl]amino]-3-methoxyphenyl]azo]naphthalene-1,3-disulfonate

EC Number:

428-480-0

EC Name:

Tetrasodium 7-[[4-[[4,6-bis[(3-sulfonatopropyl)thio]-1,3,5-triazin-2-yl]amino]-3-methoxyphenyl]azo]naphthalene-1,3-disulfonate

Cas Number:

214559-61-2

Molecular formula:

C26H24N6O13S6Na4

IUPAC Name:

tetrasodium 7-[[4-[[4,6-bis[(3-sulfonatopropyl)thio]-1,3,5-triazin-2-yl]amino]-3-methoxyphenyl]azo]naphthalene-1,3-disulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Physical state: solid
- Appearance: orange-coloured granulous powder
- Storage condition of test material: at room temperature and protected from light

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Weight at study initiation: 2.4 ± 0.3 kg (mean)
- Housing: individually in polystyrene cages
- Diet: 112 C pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France) ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): approximately 12 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

IN-LIFE DATES: From 24 June 1998 to 27 June 1998

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

- Dose administration: Approximately 100 mg of the test material was applied into the conjunctival sac of the left eye of each rabbit by gently pulling the lower lid away from the eyeball. The lower and upper eyelids were then gently held together for about 1 second to avoid any loss of test material. The right eye remained untreated and served as a control.

Observation period (in vivo):

72 hours following dose administration

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- The eyes were not rinsed after administration of the test material

SCORING SYSTEM
- The reactions observed were scored in accordance with the criteria of Draize (see field "Any other information on materials and methods incl. tables" for further information)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

other: no adverse effects observed

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

other: no adverse effects observed

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Time point:

other: overall at 24, 48 and 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: overall at 24, 48 and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: overall at 24, 48 and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: overall at 24, 48 and 72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: no adverse effects observed

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: no adverse effects observed

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: no adverse effects observed

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: no adverse effects observed

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: no adverse effects observed

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: no adverse effects observed

Irritant / corrosive response data:

Very slight or slight conjunctival reactions were observed in all animals from day 1: very slight or slight chemosis (grade 1 or 2) and very slight redness of the conjunctiva (grade 1) were observed. These reactions persisted up to day 3 at the latest. No other ocular reactions were noted during the study.

Any other information on results incl. tables

Test animals

- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France

- Diet: 112 C pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France)

Table 2: Individual ocular examination and mean values of the scores recroded at each time point for each animal

Animal no.	Region of eye	Description of ocular reaction	Scores				Mean irritation score†
			1 h	24 h	48 h	72 h
1	Conjunctivae	Chemosis	1	1	0	0	0.3
		Redness	LC	0	0	0	0.0
		Discharge	0	0	0	0	0.0
	Iris		0	0	0	0	0.0
	Corneal opacity	Intensity	0	0	0	0	0.0
		Area	0	0	0	0	0.0
	Other		*	*	*	*
	Fluorescein		N	Y	N	N
2	Conjunctivae	Chemosis	2	1	0	0	0.3
		Redness	LC	0	0	0	0.0
		Discharge	0	0	0	0	0.0
	Iris		0	0	0	0	0.0
	Corneal opacity	Intensity	0	0	0	0	0.0
		Area	0	0	0	0	0.0
	Other		*	*	*	*
	Fluorescein		N	Y	N	N
3	Conjunctivae	Chemosis	2	1	1	0	0.7
		Redness	LC	1	0	0	0.3
		Discharge	0	0	0	0	0.0
	Iris		0	0	0	0	0.0
	Corneal opacity	Intensity	0	0	0	0	0.0
		Area	0	0	0	0	0.0
	Other		*	*	*	*
	Fluorescein		N	Y	N	N

† mean of 24, 48 and 72 hour scores

* = none

N = no

Y = yes

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the test material only elicited slight reactions in any of the animals during the course of the study that meant the test material does not require classification as an eye irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.

Executive summary:

The eye irritation potential of the test material was determined in accordance with standardised guidelines OECD 405 and EU Method B.5. Approximately 100 mg of test material was applied into one eye of each of three rabbits; the animals were assessed for up to 72 hours to determine the grade of ocular reaction. Under the conditions of the study, very slight or slight conjunctival reactions were observed in all animals from day 1: very slight or slight chemosis (grade 1 or 2) and very slight redness of the conjunctiva (grade 1) were observed. These reactions persisted up to day 3 at the latest. No other ocular reactions were noted during the study. The test material was therefore determined to be not-irritating to the eye.