Registration Dossier
Registration Dossier
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EC number: 930-993-4 | CAS number: -
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- 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
- Reference substance name:
- Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- IUPAC Name:
- Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- Details on test material:
- - Name of test material (as cited in study report): Siliporite G 5100
- Related CAS number: 1318-02-1
- Lot/batch No.: MR/109/240
- surface modified with Li/rare earth elements
Constituent 1
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
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