Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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-{2-[4-({4,6-bis[(3-sulfopropyl)sulfanyl]-1,3,5-triazin-2-yl}amino)-3-methoxyphenyl]diazen-1-yl}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

Resultsopen allclose all
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
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
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
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
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
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
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
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
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
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
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
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.