Aluminium sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 2d: Meets national standards with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Materials and methods

Principles of method if other than guideline:

Method: other: FDA guideline, likely acc. to Draize Test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid, aluminum sodium salt

EC Number:

215-684-8

EC Name:

Silicic acid, aluminum sodium salt

Cas Number:

1344-00-9

Details on test material:

TS-Freetext: Sodium aluminium silicate, amorphous, size of particle
aggregates: 3.5-65 um (based on SEM), not further specified Silicic acid, aluminum sodium salt

-Name of test material : Silicic acid, aluminum sodium salt
- CAS mumber: 1344-00-9
- EC number: 215-684-8
- Generic empiricalformula: : nSiO2 • mAl203• xNa20
- Molecular weight : 60.08g/mol (SiO2)
- Substance type:inorganic
- Physical state: solid
-Colour : White
-Odour : Odourless
- Density: 2.1 g/cm3 at 20 °C
- Melting point: 1700 °C
- Boiling point: 1 >>1700 °C: not relevant for normal and intended use
- Solubility in water: 68-79 mg/l at 20 °C
- Tradenames: Sipernat, Alusil ET, Zeolex, Hydrex, Huberfil, Durabrite, Zeocopy, Tixolex, Rhodoxane

Test animals / tissue source

Species:

rabbit

Strain:

Dutch

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

Concentration: 100 % active substance
Amount applied: 100 other: mg

Duration of treatment / exposure:

48 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

6

Details on study design:

Comment: not rinsed

Results and discussion

In vivo

Results

Irritation parameter:

other: erythema 

Basis:

animal #6

Time point:

other: 12 h, 24h, 72h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Only slight erythema (score <1) after 24 h in 4/6 animals, after 48 h 1/6 animals still exhibited some effect.

Irritant / corrosive response data:

Only slight erythema (score <1) after 24 h in 4/6 animals, after 48 h 1/6 animals still exhibited some effect. No signs of irritation after 72 h

Any other information on results incl. tables

RS-Freetext:
Only slight erythema (score <1) after 24 h in 4/6 animals,
after 48 h 1/6 animals still exhibited some effect. No signs
of irritation after 72 h.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information No signs of irritation after 72 h. Criteria used for interpretation of results: OECD GHS

Conclusions:

Only slight erythema (score <1) after 24 h in 4/6 animals, after 48 h 1/6 animals still exhibited some effect. No signs of irritation after 72 h.