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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:
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:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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