Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000/09/28 - 2000/10/01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

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

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Covance Research Products, Inc., Denver PA

- Age at study initiation: Young adult

- Weight at study initiation: 2750 to 2981 g at initiation of dosing

- Housing: Individual suspended wire mesh cages. The animals were maintained by the animal husbandry staff of WIL Research laboratories, Inc., in accordance with standard operating procedures.

- Diet: PMI Nutrition International, Inc. Certified Rabbit LabDiet 5322 was offered at approximately 150 g per day during the study.

- Water: Municipal water was provided ad libitum

- Acclimation period: minimum of 7 days


ENVIRONMENTAL CONDITIONS

- Temperature (°F): 67-68 (19.4-20 °C)

- Humidity (%): 50-59

- Photoperiod (hrs dark / hrs light): 12/12


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: none
Controls:
no
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5ml

- Concentration (if solution): undiluted

Duration of treatment / exposure:
4 hour(s)
Observation period:
72 hours
Number of animals:
2M, 1F
Details on study design:
TEST SITE

- Area of exposure: dorsal skin

- Type of wrap if used: A two - ply gauze patch secured in place with tape. The patches were overwrapped with gauze binder and secured with tape.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): The test site was wiped with a disposable paper towel moistened with deionized water.

- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
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
Irritant / corrosive response data:
A primary irritation index of 0.1 was calculated from the results, consistent with a descriptive rating classification of slightly irritating.
Other effects:
No deaths or remarkable body weight changes were observed. Very slight erythema was noted for one animal at the 30-60 minute observation. There was no edema, nor were there any other dermal findings.  

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the skin irritation study, conducted according to OECD TG 404, and in compliance with GLP, the test substance, 3-trimethoxysilylpropyl methacrylate, was reported to be not irritating to skin.