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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:
11-02-1994 to 22-03-1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted according to the appropriate OECD test guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not reported.
- Age at study initiation: Young adult.
- Weight at study initiation: 3235 - 3389 g
- Housing: Individual suspended wire-mesh cages.
- Diet: Purina® Certified Rodent Chow® #5322 provided ad libitum
- Water: Municipal water were provided ad libitum
- Acclimation period: The animals were acclimated to laboratory conditions for a minimum of six days prior to initiation of dosing.

ENVIRONMENTAL CONDITIONS
- Temperature : 66-70°F
- Humidity (%): 32-70
- Photoperiod (hrs dark / hrs light): 12/ 12.

IN-LIFE DATES: From: 08-04-1994 To: 22-04-1994.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:
4 h
Observation period:
14 days
Reading time points: 30-60 min, 24, 48, 72 h and daily to day 14.
Number of animals:
1 male and 2 females
Details on study design:
TEST SITE
- Area of exposure: One inch square patch on the back of the rabbit.
- % coverage: 20-25 %
- Type of wrap if used: Each 0.5 ml dose was applied under a 2-ply, one inch square gauze patch secured in place with surgical porous tape, that was overwrapped with a gauze binder and secured with Dermiform® tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The site was wiped with disposable paper towels moistened with deionised water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 d.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 14 d. Although very slight erythema persisted through study termination for a single animal this irritation was considered to be reversible.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Other effects:
The test material induced moderate to slight erythema on two and one rabbits, respectively. All rabbits had very slight edema. Desquamation was noted for all rabbits by Day 5. Dermal irritation subsided by Day 14 for one animal. Desquamation persisted through Day 14 for two rabbits. Very slight erythema was present on Day 14 for one animal. There were no other dermal findings.

Any other information on results incl. tables

Table 1. Results of skin irritation study

Observation time

Rabbit no.

1

2

3

E*

O*

E

O

E

O

1 h

2

1

2

1

2

1

24 h

2

1

2

1

2

1

48 h

3

1

3

0

2

1

72 h

3

1

3

0

2

1

Mean value
24 +48 + 72 h

2.67

1.00

2.67

0.33

2.00

1.00

Mean value
24 +48 + 72 h,
all animals

2.44

0.77

 

 

 

 

 

* E: erythema, O: oedema (according to Draize Score)

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal irritation/corrosion study conducted according to OECD 404 and GLP, the primary irritation index was calculated to be 3.1. The test material, triethoxysilane produced moderate, reversible dermal irritation under the conditions of this study and therefore classified as a Category II skin irritant (EU).