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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:
19 Nov 1986 - 22 Nov 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was conducted according to an appropriate OECD test guideline with acceptable restrictions. The restriction was a shorter observation time (reversibility of effects not fully assessable) than stated in the guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1981
Deviations:
yes
Remarks:
shorter observation period than specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Catalyseur 30 532 - Vinyltris (methylethylcetiminoxy) silane
- Substance type: Alkoxysilane
- Physical state: liquid
- Storage condition of test material: minimum 19°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Saint Aubin les Elbeuf, 76410 Cleon, France
- Weight at study initiation: 2.5 ± 0.2 kg
- Housing: individually, in polystyrene cages
- Diet: rabbit complete pelleted maintenance food (U.A.R. formula "112", U.A.R., Villemoisson Sur Orge, 91360 Epinay Sur Orge, France), ad libitum
- Water: softened and filtered drinking water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: 100%
Duration of treatment / exposure:
4 h
Observation period:
72 h (the protocol describes examinations up to 14 days, but no observations are reported later than 72 h)
Reading time points: 1, 24, 48, 72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Covered with a Codex hydrophilic eight layer gauze patch kept in contact with the skin by a wide perforated tape applied on a crimped gauze bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: no data
- Time after start of exposure: After 4 hours the bandage was removed.

SCORING SYSTEM: Draize scheme

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test.

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

1/1/1/1/1/1

0/0/0/0/0/0

24 h

0/1/1/1/1/1

0/0/0/0/0/0

48 h

0/0/1/1/1/1

0/0/0/0/0/0

72 h

0/0d/1d/1d/1d/1d

0/0/0/0/0/0

Average 24h, 48h, 72h

0.7

0

Reversibility by 72 h*

n

-

* Reversibility: c = completely reversible; n.c.= not completely reversible; n = not reversible

d = desquamation

 

Applicant's summary and conclusion

Interpretation of results:
other: Non irritating (according to CLP regulation)
Conclusions:
A reliable study conducted broadly in accordance with OECD 404 and GLP, found the test material to be non- irritating to the skin of rabbits. Mild erythema remained in some animals the end of the short observation period (72 h), but no oedema was reported at any time point.
Executive summary:

An acute dermal irritation/corrosion test was conducted in accordance with OECD 404 and GLP. The substance butan-2-one O,O',O''-(vinylsilanetriyl)oxime was found to be non-irritating to the skin of rabbits. Mild erythema (score of 0.7, mean 24 -72, 6 animals) remained in some animals at the end of the short observation period (72 h) but no oedemas was observed (score of 0).