Zeolite, silica rich, crystalline, synthetic, non-fibrous

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 Jan 1989 - 03 Feb 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: basic data given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Federal Register (191, December, 1972)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

oxo[(oxoalumanyl)oxy]alumane silanedione hydrate sodium

EC Number:

930-985-0

Cas Number:

1318-02-1

Molecular formula:

M2/nO • Al2O3 • ySiO2 • wH2O (n is the valency of the cation M, predominantly Na, and for Na is n=1; y can range from 2 to 222, and w is the number of water molecules typically between 4 and 40. The composition based on the metals present in the zeolite is typically: Na: 0 - 19.0%, Al: 0,3 - 19.0%, Si: 16.6 - 46.1% (general composition); additionally, depending on the water quality: Ca, Mg and K might be present below 5%

IUPAC Name:

oxo[(oxoalumanyl)oxy]alumane silanedione hydrate sodium

Details on test material:

- Name of test material (as cited in study report): Zeolite S-D
- Framework: orthorhombic
- Related CAS number: 1318-02-1
- Analytical purity: 99.4wt%
- Impurities: 0.79wt% Al203, <0.01% Na2O, 11.6% L0I
- Substance type: white powder

Test animals

Species:

rabbit

Strain:

other: Japanese White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.61 - 2.85 kg
- Diet (e.g. ad libitum): solid diet for rabbits (RM-3 feeding); ad libitum
- Water (e.g. ad libitum): water; ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 h

Observation period:

4, 24, 48 and 96 h after contact with test substance

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: non-irritating tapes (no further details)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): webbed with distilled water
- Time after start of exposure: 4 h


SCORING SYSTEM:
Calculation of Primary Irritation Index from data of erythema and eschar formation (Grade 0 to 4) and edema formation (grade 0 to 4).

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

6 animals

Time point:

other: 4, 24, 48 and 96 h

Score:

0

Remarks on result:

other: calculated value 0.003

Any other information on results incl. tables

In one of 6 animals very slight erythema (grade 1) occured 48 h after exposure to the test article which was still present after 96 h.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information