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Toxicological information

Skin irritation / corrosion

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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:
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:
other: Federal Register (191, December, 1972)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Zeolite S-D
- Chemical name: Zeolite, silica rich, crystalline, synthetic, non-fibrous
- 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 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