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Diss Factsheets

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:
2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
No data
Deviations:
no
Remarks:
No deviations ocurred that impacted the integrity of the study.
GLP compliance:
yes (incl. QA statement)

Test material

1
Reference substance name:
Reactionmass of octan-2-yl prop-2-enoate and octan-3-yl prop-2-enoate and octan-4-yl prop-2-enoate
EC Number:
947-155-9
Molecular formula:
C11H20O2
IUPAC Name:
Reactionmass of octan-2-yl prop-2-enoate and octan-3-yl prop-2-enoate and octan-4-yl prop-2-enoate
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Company, Lot 11
- Purity, including information on contaminants, isomers, etc.: 99.7%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Kept in a room with controls set to maintain 18°C to 24°C

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding):
None, dosed neat.

FORM AS APPLIED IN THE TEST (if different from that of starting material)
: The test article was dosed neat.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Inc.
- Age at study initiation: 1.5
- Weight at study initiation: 3.9-4.3 kg
- Housing: Individually housed in stainless steel cages elevated above corncob bedding.
- Diet (e.g. ad libitum): PMI Nutrition International, LLC Certified High Fiber Rabbit Diet 5325. Approximately 150 g/day was offered during the study.
- Water (e.g. ad libitum): Tap water, treated by reverse osmosis and UV irradiation, ad libitum.
- Acclimation period: At least 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22 C
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 01 July, 2019 To: 22 July, 2019

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

NEGATIVE CONTROL : No treatment

POSITIVE CONTROL : None
Duration of treatment / exposure:
4 hours
Observation period:
Observations were made at 24, 48 and 72 hours post patch removal and 4, 7, 14, 18 and 21 days post-removal.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm area of skin
- Type of wrap if used: 2-ply gauze patch secured in place with surgical porous tape. The patches were overwrapped with a gauze binder and secured with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of 4 hours, the bandages were removed and the sites wiped with disposable paper towels moistened with deionized water
- Time after start of exposure: 4 hours.

OBSERVATION TIME POINTS
Observations were made at 24, 48 and 72 hours post patch removal and 4, 7, 14, 18 and 21 days post-removal.

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 5 days
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 8 days
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 15 days
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 19 days
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 22 days
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 5 days
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 8 days
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 15 days
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 19 days
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 22 days
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 5 days
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 8 days
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 15 days
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 19 days
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 22 days
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 22 days
Remarks:
22 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
No edema was observed in animal 1 at any observation point through 22 days during the study
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
No edema was observed in animal 2 at any observation point through 22 days during the study
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
No edema was observed in animal 3 at any observation point through 22 days during the study
Irritant / corrosive response data:
Average erythema individual scores (24, 48, and 72 hours) were 1.67, 2.0, and 1.33. Significant erythema persisted during days 15-19 for all three animals. No edema was observed. The Primary Irritation Index (PII) was 1.3.
Other effects:
- Other adverse local effects: Skin flaking was overved in animal 1 at Day 15.
- Other adverse systemic effects: None.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The Primary Irritation Index (PII) was 1.3. The 24, 48, and 72 hours erythema scores indicate a Cat. 3. However, given the irritation seen at days 15-19, MTDID 44430 will be classified as a Skin 2 per GHS and CLP.
Executive summary:

The skin irritation potential of MTDID 44428 was examined in a study conducted according to OECD 404 in compliance with OECD GLP.  New Zealand White rabbits (N = 3) received a single, 4-hour, semi-occluded exposure of 0.5 mL MTDID 44428, which was applied to clipped, unabraded skin. Application sites were evaluated at approximately 30-60 minutes and 24, 48, and 72 hours after patch removal, and 4, 7, 14, 18, and 21 days after removal (Days 5, 8, 15, 19, and 22, respectively). There were no deaths or remarkable body weight changes noted during the study. Average erythema individual scores (24, 48, and 72 hours) were 1.67, 2.0, and 1.33. Significant erythema persisted during days 15-19 for all three animals. No edema was observed. The Primary Irritation Index (PII) was 1.3. The 24, 48, and 72 hours erythema scores indicate a Cat. 3. However, given the irritation seen at days 15-19, MTDID 44430 will be classified as a Skin 2 per GHS and CLP.