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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:
10th March 1997 to 14th March 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
other: small white Russian Mol:Russian / Chbb:HM
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Møllegaard Breeding/Research Centre Ltd., Tornbjergvej 40, Ejby DK-4623 LI. Skensved, Denmark
- Age at study initiation: no information
- Weight at study initiation: 2.3, 2.3 and 2.4 kg
- Housing: conventional, single animal per stainless steel cage.
- Diet: Ssniff K4 complete diet for rabbits ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³
- Concentration (if solution): undiluted
Duration of treatment / exposure:
Four hours
Observation period:
30-60 minutes, 24, 48 and 72 hours, and 6 days after removal of the patch.
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: gauze covered with a non-irritating bandage and then a semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water
- Time after start of exposure: four hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: at 30-60 minutes, 24, 48 and 72 hours after removal
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: at 30-60 minutes, 24, 48 and 72 hours after removal
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: at 30-60 minutes, 24, 48 and 72 hours, and 6 days after removal
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: at 30-60 minutes, 24, 48 and 72 hours, and 6 days after removal
Score:
0 - 1
Max. score:
4
Remarks on result:
other: very slight edema was observed at 48 and 72 hours after patch removal
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: at 30-60 minutes, 24, 48 and 72 hours, and 6 days after removal
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: at 30-60 minutes, 24, 48 and 72 hours, and 6 days after removal
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
[2-(perfluorohexyl)ethyl]triethoxysilane has been tested for acute skin irritation in a semi-occlusive study conducted according to OECD TG 404 and in compliance with GLP. Very slight erythema was observed after 30-60 minutes, and 2, 48 and 72 hours, in two of the three small white Russian rabbits exposed to the undiluted test substance for four hours. One animal showed very slight edema 48 and 72 hours after the removal of the bandage. All signs of irritation had reversed by 6 days after application. One animal showed no signs of skin irritation during the entire observation period. It is concluded that the test substance is not irritating to the skin.