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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:
26 October 2004 to 16 December 2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The restrictions were larger area of test substance application than recommended in guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(area of test substance application was 16 cm2, guideline recommends 6 cm2)
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: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 11 weeks (male), 12 weeks (females)
- Weight at study initiation: 2141 g (male), 2194-2198 g (females)
- Housing: Individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet, ad libitum
- Water: Community tap water ad libitum
- Acclimation period: 5 days under laboratory conditions after health examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 26-Oct-2004 To: 15-Nov-2004

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/animal
- Concentration (if solution): 100%

Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
1 male, 2 females
Details on study design:
TEST SITE
- Area of exposure: 16 cm2 on left flank
- % coverage: No data
- Type of wrap if used: Surgical gauze patch covered with a semi-occlusive dressing wrapped around the abdomen and anchored with tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Flushed with lukewarm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Numerical scoring system listed in Commission Directive 2004/73/EC (based on the Draize score system) approximately 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the patch

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
8
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Very slight (score 1) to well-defined erythema (score 2) was noted in all animals 1 hour after treatment. Well-defined erythema (score 2) was noted in all animals from the 24- to the 72-hour examination. Very slight (score 1) to well-defined (score 2) erythema was noted in all animals at the 7-day examination and very slight erythema (score 1) persisted in 1 animal up to the 10-day examination. Scaling was noted in 1 animal at the 72-hour examination and in all animals from the 7- to the 14-day examination. No oedema was seen in animal at any timepoint. There were no alterations of the treated skin nor corrosive effects.
Other effects:
No clinical signs of systemic toxicity, mortality or effects on body weight.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
In a 4-hour skin irritation study in rabbits, conducted according to OECD test guideline 404 and in compliance with GLP, undiltued tri(isopropyl)silyl acrylate was a skin irritant.
Executive summary:

Tri(isopropyl)silyl acrylate was tested in an skin irritation test, conducted to OECD test guideline 404 and in compliance with GLP.

Undiluted test material (0.5ml) was applied to the left flank of 3 rabbits for 4 hours and skin was examined for signs of irritation and corrosion 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the patch.

Signs of irritation were seen at the 1-, 24-, 48- and 72-hour, 7- and 10-day time points, but these had disappeared by the 14-day time point. Scaling, evident from the 72-hour time point, persisted to the end of the observation period. No corrosive effects were noted.