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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline 404: GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

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

Test material

Constituent 1
Details on test material:
- Substance type: Commercial product
-Molecular weight: 144.25

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazelton Research Products
- Age at study initiation: 16-18 weeks
- Weight at study initiation: 2.82-3.18 kg
- Housing: individually
- Diet (e.g. ad libitum): Agway certified diet R.C.A, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 22 Days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12

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
- Concentration (if solution): assumed 100%
Duration of treatment / exposure:
4 hours
Observation period:
45 minutes, 24, 48, 72 hours and 7 days post patch removal
Number of animals:
6 females
Details on study design:
TEST SITE
- Area of exposure: Dorsal surface from the shoulder region to the lumbar region
- Type of wrap if used: semi-occlusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water at paper towel
- Time after start of exposure: Immediately after the 4 hour exposure


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
ca. 1.83
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: One animal displayed slight erythema at Day 7
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
ca. 0.22
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI637F
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI637F
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI637F
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI637F
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI637F
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI637F
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI626F
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI626F
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI626F
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI626F
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI626F
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI626F
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI636F
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI636F
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI636F
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI636F
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI636F
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI636F
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI634F
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI634F
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI634F
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI634F
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI634F
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI634F
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI539F
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI539F
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI539F
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI539F
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI539F
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI539F
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI601F
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI601F
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: Animal: JEI601F
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI601F
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI601F
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: Animal: JEI601F
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Topical application elicited well-defined erythema in 2 animals and very slight erythema in the 4 remaining animals at the 45 minute interval. Five animals were noted with well-defined erythema at the 24, 48, and 72 hour intervals, with the remaining animal noted with very slight erythema. One animal was noted with very slight erythema at the day 7 interval. Very slight edema was noted in one animal at the 48 hour interval and in three animals at the 72 hour interval. Desquamation was noted in all six animals at Day 7.

Any other information on results incl. tables

Individual animal dermal scores:

 Animal ID    45 minutes  24 hours  48 hours  72 hours  7 days
 JEI637F  Erythema  2  2  2  2  0
   Edema  0  0  1  1  0
 JEI626F  Erythema  1 2 2 2  1 
   Edema  0 0  0  1  0 
 JEI636F  Erythema  1 2  2  2  0 
   Edema  0 0  0  0  0 
 JEI634F  Erythema  2 2  2  2  0 
   Edema  0 0  0  1  0 
 JEI539F  Erythema  1 1  1  1  0 
   Edema  0 0  0  0  0 
 JEI601F  Erythema  1 2  2  2  0 
   Edema  0 0 0  0  0 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Branched alcohols, C8-C10, C9-rich is a skin irritant.
Executive summary:

In this study, rabbits were subjected to a 4-hour exposure to isononanol via a semi-occlusive dermal application.  Dermal reactions were scored to erythema and edema according to the method of Draize at 45 minutes, 24, 48, and 72 hours and 7 days post patch removal.  All animals exhibited some signs of erythema and edema within 48 hours post patch removal. The mean skin irritation scores between 24 and 72 hours were: erythema 1.83 and edema 0.22. All six animals exhibited desquamation at Day 7.