Zeolite, cuboidal, crystalline, synthetic, non fibrous, thermally produced

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

1996-09-24 to 1996-09-29

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP guideline study, tested with the source substance Zeolite, cuboidal, crystalline, synthetic, non fibrous. According to the ECHA Guidance Document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

- Name of test material (as cited in study report): Siliporite G 5100
- Chemical name: Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- Framework: cuboidal
- Related CAS number: 1318-02-1
- Analytical purity: no data
- Lot/batch No.: MR/109/240
- surface modified with Li/rare earth elements

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: closely-clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

500 mg, undiluted
6 cm² moistened gauze pad

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

A single dose of 500 mg of the test substance was applied to the closely-clipped skin of the flank (6 cm² moistened gauze pad). The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately one hour, 24, 48 and 72 hours after removal of the dressing.
The test substance was applied in a first assay for a period of 3 minutes and 4 hours to one male New Zealand White rabbit. Since the test substance was not irritating in this first assay, the test substance was applied for 4 hours to two other males in a second assay.
The mean values of the scores for erythema and oedema were calculated for each animal.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

3 animals

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Reversibility:

other: no effects

Irritant / corrosive response data:

No cutaneous reactions were observed during the study, whether the test substance was applied for 3 minutes of for 4 hours.

Any other information on results incl. tables

The interpretation of results was carried out according to the classification criteria laid down in Directive 93/21/E,E.C. (27th April 1993) adapting to technical progress for the eighteenth time Council Directive 67/548/E.E.C.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information