Silicic acid, aluminum salt

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 Mar - 31 Mar 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP- Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: ICCVAM Test Method Evaluation Report: Appendix G -> ICCVAM recommended HET-CAM Method Protocol (Nov 2006)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Straße 7, 55116 Mainz, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid, aluminum salt

EC Number:

215-628-2

EC Name:

Silicic acid, aluminum salt

Cas Number:

1335-30-4

Molecular formula:

[SiO4]a * [AlO3]b a: 0.735-0.885, b: 0.115-0.265

IUPAC Name:

Silicic acid, aluminum salt

Details on test material:

- Name of test material (as cited in study report): Silicic acid, aluminium salt
- CAS No.: 1335-30-4
- Physical state / appearance: white crystalline powder
- Composition: >99% aluminium silicate
- Purity: >99%
- Lot/batch No.: 3080270
- Expiration date of the lot/batch: 09/2011
- Storage condition of test material: room temperature 20 +/- 5 °C, dry, closed vessel

Test animals / tissue source

Species:

other: Freshly laid Lohmann Leghorn chicken eggs

Strain:

other: not required

Details on test animals or tissues and environmental conditions:

TEST ANIMALS/TEST SYSTEM
- Source: LSL Rhein Main Geflügelvermehrungsbetrieb (Dieburg, Germany)
- Age at study initiation: The eggs were incubated for nine days before start of the experiment
- Housing: still air incubator, eggs were rotated

ENVIRONMENTAL CONDITIONS in the incubator
- Temperature: 38.5 C°+/- 0.2 °C
- Humidity: 58% +/- 2%

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: control eggs

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume): 300 µL
- Amount(s) applied (weight with unit): 161.5 mg (mean of six replicates)

Duration of treatment / exposure:

5 minutes

Observation period (in vivo):

5 minutes

Number of animals or in vitro replicates:

6 eggs were used for the test item

Details on study design:

Negative control: sodium chloride solution (0.9%)
Positive controls: sodium dodecyl sulphate solution (1%)
and sodium hydroxide solution (0.1 -N)

24 hours before the start of the experiment, the chicken eggs were candled and non-viable eggs were discarded. On the day of the test, the nine day incubated egg was opened on the air bubble with a rotating dentist's saw blade. The inner membrane was moistened with 0.9% NaCl, then, the egg was left to stand into the incubator for 30 minutes. After this period, the solution was decanted and the inner membrane was carefully removed with a forceps.
Then 300 µL of the test item was given directly onto the chorioallantoic membrane (CAM) surface.
The test item was given on the membrane in such a manner that 50% of the surface of the membrane was covered with test item. The reactions on the CAM were observed over a period of 300 seconds. The following endpoints are described in the guideline: haemorrhage (bleeding from vessels), vascular lysis (blood vessel disintegration) and coagulation (intra- and extra-vascular protein denaturation). The time for the appearance of each of the noted endpoints was monitored and recorded in seconds. The Irritation score of the negative controls should be <0.9 and the positive controls >9. Additional, the controls were compared with the historical control data range showing the validity of the test.

SCORING SYSTEM: Irritation score =[((301 - time until haemorrhage)/ 300) x 5] + [((301 - time until lysis)/ 300) x 7] + [((301 - time until coagulation)/ 300) x9]

Results and discussion

In vivo

Irritant / corrosive response data:

Physiological sodium chloride solution was used as negative control and showed no irritating effect on the blood vessels under the membrane. Solutions of SDS (Sodium dodecylsulphate) and NaOH were used as positive controls and induced a severe irritation on the blood vessels. The irritation score of the controls lay within the demanded range. The test item Silicic acid, aluminium salt was tested pure. The calculated mean irritation score is 9.78. In conclusion, it can be stated that in this study and under the experimental conditions reported, Silicic acid, aluminium salt possesses a severe irritation potential.

Any other information on results incl. tables

Table 1: Experimental Observations

Test Group	Amount applied	Time until Haemorrhage in seconds	Time until Lysis in seconds	Time until Coagulation in seconds
Negative control	300 µL	301	301	301
	300 µL	301	301	301
	300 µL	301	301	301
Positive control 0.1-N NaOH	300 µL	7	31	17
	300 µL	8	25	16
	300 µL	7	23	15
Positive control 1% SDS	300 µL	16	32	301
	300 µL	12	28	301
	300 µL	13	29	301
Silicic acid, aluminium salt	154.4 mg (300 µL)	22	78	301
	158.7 mg (300 µL)	33	95	301
	162.2 mg (300 µL)	30	71	301
	159.7 mg (300 µL)	12	81	301
	168.8 mg (300 µL)	14	100	301
	165.4 mg (300 µL)	14	66	301

Note: when no reaction of the chorioallantoic membrane (CAM) was observed, the value “301” was stated for mathematical reasons. 300 µL of the solid test item was measured volumetrically.

Remark:

The irritation score (0) of the negative control was within the range (0 - 0) of the historical data of the test facility. The values of the positive controls were within the range (19.85 (NaOH) is between 19.00 - 19.98 and 11.12 (SDS) is between 9.93 - 11.14) ) of historical data of the test facility up to 23 Mar 2010, too.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information