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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:
120 hours
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

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

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: Harlan Winkelmann GmbH
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing:ABS - plastic cages, floor 4200 cm2
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Described as 'adequate'.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18± 3
- Humidity (%): 55± 10
- Air changes (per hr): at least 10
- 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 ml


Duration of treatment / exposure:
Four hours.
Observation period:
120 hours
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage: Not stated
- Type of wrap if used: gauze patch held in place with non-irritating tape and semi-occlusive dressing.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with water.
- Time after start of exposure: Four hours.


SCORING SYSTEM: As per OECD 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
ca. 1.3
Max. score:
3
Reversibility:
fully reversible within: 120 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: No oedema in any of the animals
Irritant / corrosive response data:
Very slight to moderate irritant effects (erythema) in all three animals on the intact skin 24 hours after patch removal. Very slight to well-defined skin reactions (erythema) in two animals at 48 and 72 hours. At the 96 hour reading a very slight erythema was still found in one animal. By 120 hours there were no signs of irritation.
Other effects:
There were no significant body weight changes at any point in the study. There were no other signs of toxicity.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a good quality (reliability 1) primary skin irritation study conducted according to OECD 404 and GLP, Wacker BS 1701 (alkylalkoxysilane) was very slight to moderately irritating to rabbit skin. The observed effects do not warrant classification according to EU criteria.
Executive summary:

Wacker BS 1701 (alkylalkoxysilane) was applied to one side of the closely clipped backs of three New Zealand white rabbits at a dose of 0.5 ml per application site under a semi-occlusive dressing. The other side of the untreated skin on the backs of the rabbits served as the controls. After the four hour application period, the dressing was removed and excess test substance was washed off the skin with water. Observations were recorded and compared to the control sites at 1, 24, 48, 72, 96 and 120 hours after removal of the dressing. Very slight to moderate irritant effects (erythema) were observed in all three animals after 24 hours. Very slight to well-defined skin reactions (erythema) were observed in two animals at 48 and 72 hours. At the 96 hour reading a very slight erythema was still found in one animal. However, by 120 hours there were no signs of irritation. No clinical signs of toxicity were observed.