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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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

Test material

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): 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 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