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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan. 12-15, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: nanoform, surface-treated
Specific details on test material used for the study:
experimental fumed silica (batch no. SP 12-7033)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
obtained from: Buckmasters, Henham, England; c. 2.1-2.6 kg, c. 9-11 wk. old, individually caged, c. 19 °C, 30-70% humidity

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
destilled, 0.5 ml
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
3 days
Number of animals:
3
Details on study design:
treatment sites washed after 4-hour treatment; one application site per rabbit

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 - #3
Time point:
other: 30 min
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: #1 - #3
Time point:
other: 1 d
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: #1 - #3
Time point:
other: 2 d
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: #1 - #3
Time point:
other: 3 d
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #1 - #3
Time point:
other: 30 min
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #1 - #3
Time point:
other: 1 d
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #1 - #3
Time point:
other: 2 d
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #1 - #3
Time point:
other: 3 d
Score:
0
Max. score:
0
Irritant / corrosive response data:
All three animals showed no response to treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide was not irritating to skin
Executive summary:

The dermal irritation potential of fumed amorphous silicon dioxide was assessed in rabbits.