Xanthylium, 3,6-bis(diethylamino)-9-[2-(ethoxycarbonyl)phenyl]-, molybdatetungstatephosphate

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

the chorioallantoic membrane (CAM) of chicken eggswas investigated

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 March 2004 - 23 March 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Principles of method if other than guideline:

The study procedures described in this report are based on the following papers:

Weterings, P.J.J.M. and van Erp, Y.H.M. (1987). Alternative methods in Toxicology Vol. V.: In Vitro Toxicology - Approaches to Validation. Ed. A.M. Goldberg, M.A. Liebert Inc. NY, USA.

LOpke, N.P. (1985), Hen's egg chorioallantoic membrane test for irritation potential, Fd. Chem. Toxicol. 23, 287.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Xanthylium, 3,6-bis(diethylamino)-9-[2-(ethoxycarbonyl)phenyl]-, molybdatetungstatephosphate

EC Number:

215-414-9

EC Name:

Xanthylium, 3,6-bis(diethylamino)-9-[2-(ethoxycarbonyl)phenyl]-, molybdatetungstatephosphate

Cas Number:

1326-04-1

IUPAC Name:

Reaction product of 6-(diethylamino)-9-(2-ethoxycarbonylphenyl)xanthen-3-ylidene]-diethylazanium chloride with phosphotungstomolybdic acid

Test material form:

solid: nanoform

Details on test material:

Shape
Shape Category: spheroidal
Shape: spherical
Pure Shape:no
Typical Composition: ≤100%
range: >0; ≤100%

Particle size distribution & range
Shape Category: spheroidal
Percentile D10, typical value: 40nm
Percentile D10, range: ≥10; ≤60nm
Percentile D50, typical value: 60nm
Percentile D50, range: ≥40; ≤100nm
Percentile D90, typical value: 90nm
Percentile D90, range: ≥60; ≤150nm
Fraction in size range 1-100nm:≥50; ≤100%

Crystallinity
structure: Amorphous
Pure structure: Yes

Specific Surface Area
Typical specific surface area: ca. 40m2/g
Range: ≥10; ≤200m2/g
Skeletal Density: 2.1 g/cm3

Surface Functionalisation/treatment
surface treatment applied no

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:0245N/041020
- Expiration date of the lot/batch: 16 March 2005
- Purity: 100%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark

Test animals / tissue source

Species:

other: chicken egg

Strain:

not specified

Details on test animals or tissues and environmental conditions:

- Source: chicken breeding centre (Het Anker, Ochten, the Netherlands).
- Acclimation period:

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

0.2mL

Duration of treatment / exposure:

20 seconds

Duration of post- treatment incubation (in vitro):

The effects on the blood capillaries were evaluated 30 seconds after application (immediately after rinsing) and 1.5 and 4.5 minutes later

Number of animals or in vitro replicates:

4 test eggs and 12 control eggs

Details on study design:

White eggs were incubated in the incubator with the air chamber upwards. The temperature was maintained at 37 ± 1°C and the relative humidity between 50 and 80%. The eggs were turned once every hour. They were candled at the seventh day of incubation; unfertilised eggs or eggs containing a dead embryo were removed.
On the tenth day of incubation the egg shell was opened above the air chamber with a rotating polisher, and the shell with the attached membrane was removed until the margin of the air chamber. The inner egg membrane was then carefully eliminated to expose the CAM. To avoid capillary bleeding, 0.1 ml of water was placed on a small nick made in the inner egg membrane before picking it up with a fine-pointed forceps. The test substance was applied to the CAM. Twenty seconds after application the CAM was carefully rinsed with approximately 7 ml of tepid water.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 30 seconds, 2 mins, 5 mins

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 30 seconds, 2 mins, 5 mins

Score:

0

Max. score:

0

Reversibility:

other: n/a

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 30 seconds, 2 mins, 5 mins

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

other: 30 seconds, 2 mins, 5 mins

Score:

0

Max. score:

0

Reversibility:

other: not aapplicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

CAM ASSAY
Injection: No injection was observed.
Haemorrhage: No haemorrhages were observed.
Coagulation: No coagulation was observed.

LUMIERE PINK 0245N revealed neither corneal damage nor any effects on the CAM.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LUMIERE PINK 0245N revealed neither corneal damage nor any effects on the CAM.

It is concluded that negligible irritation may be expected after acute eye exposure to test substance LUMIERE PINK 0245N.