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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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
The skin irritation information of this source substance is used for read across to Hyacinth body #3.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Information derived from analogue
Justification for type of information:
The read across justification is presented in the Irritation / corrosion Endpoint summary. The accompanying files are also attached there.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
other:
Remarks:
scores of animal number 1, 2 and 3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other:
Remarks:
24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
other:
Remarks:
scores of animal number 4 and 6
Time point:
24/48/72 h
Score:
1
Remarks on result:
other:
Remarks:
24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
other:
Remarks:
score of animal number 5
Time point:
24/48/72 h
Score:
2
Remarks on result:
other:
Remarks:
24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
other:
Remarks:
scores of animal number 1, 2 and 3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other:
Remarks:
24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
other:
Remarks:
score of animal number 5
Time point:
24/48/72 h
Score:
1
Remarks on result:
other:
Remarks:
24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
other:
Remarks:
score of animal number 3
Time point:
other: 0 h
Score:
0
Irritation parameter:
erythema score
Basis:
other:
Remarks:
scores of animal number 1 and 2
Time point:
other: 0 h
Score:
1
Irritation parameter:
erythema score
Basis:
other:
Remarks:
scores of animal number 4 and 6
Time point:
other: 0 h
Score:
2
Irritation parameter:
erythema score
Basis:
other:
Remarks:
score of animal number 5
Time point:
other: 0 h
Score:
3
Irritation parameter:
edema score
Basis:
other:
Remarks:
scores of animal number 1, 2 and 3
Time point:
other: 0 h
Score:
0
Irritation parameter:
edema score
Basis:
other:
Remarks:
scores of animal number 4, 5 and 6
Time point:
other: 0 h
Score:
1
Irritant / corrosive response data:
The test substance was found to induce some skin irritation effects. After 24 hours exposure very slight to moderate erythema and very slight edema was observed. Dermal effects observed 48 hours after patch removal were very slight or well-defined erythema, slight scaliness and very slight edema.

To be able to derive a CLP classification from skin irritation test results, normally the 24, 48 and 72 hours timepoints (after patch removal) for erythema and edema are used. In this study only the 48 hours timepoint is available for evaluation. As supporting evidence the reading directly after removal of the patch is available (0 hours timepoint) and can be considered the worst-case effect. Based on the available eythema and edema scores and the longer exposure period (24 instead of 4 hours), it is concluded that interpretation of the study for CLP purposes is possible with the current test.

Interpretation of results:
other: not skin irritating
Remarks:
Based on CLP criteria (EC 1272/2008 and its updates)
Conclusions:
Skin irritation: not irritating (read-across from Hyacinth body tested in OECD TG 404).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
exposure period was 24 h instead of 4 h, observation time points were 0 and 48 h after patch removal instead of 24, 48 and 72 h.
GLP compliance:
no
Remarks:
pre-GLP

Test material

1
Chemical structure
Reference substance name:
[2-(1-ethoxyethoxy)ethyl]benzene
EC Number:
219-868-9
EC Name:
[2-(1-ethoxyethoxy)ethyl]benzene
Cas Number:
2556-10-7
Molecular formula:
C12H18O2
IUPAC Name:
[2-(1-ethoxyethoxy)ethyl]benzene

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Details on test animals or test system and environmental conditions:
No details provided.

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Remarks:
electric clipper, avoiding abrasions
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml testing material
Duration of treatment / exposure:
24 hours
Observation period:
48 hours after patch removal
Number of animals:
12 animals - 6 with intact skin and 6 with abraded skin (results for abraded skin are disregarded in this study record).
Details on study design:
TEST SITE:
- Area of exposure: 1x1 inch
- Type of wrap if used: surgical patch, fixed to application site with adhesive tape and entire trunk of rabbits is wrapped with impervious material.

OBSERVATION TIME POINTS:
After 24 hours (directly after exposure) and after 72 hours (48 hours after patch removal).

SCORING SYSTEM:
Method of calculation: Draize (J. Pharmacol. 82 (1944) 377-390).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other:
Remarks:
scores of animal number 1, 2 and 3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other:
Remarks:
24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
other:
Remarks:
scores of animal number 4 and 6
Time point:
24/48/72 h
Score:
1
Remarks on result:
other:
Remarks:
24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
other:
Remarks:
score of animal number 5
Time point:
24/48/72 h
Score:
2
Remarks on result:
other:
Remarks:
24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
other:
Remarks:
scores of animal number 1, 2, 3, 4 and 6
Time point:
24/48/72 h
Score:
0
Remarks on result:
other:
Remarks:
24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
other:
Remarks:
score of animal number 5
Time point:
24/48/72 h
Score:
1
Remarks on result:
other:
Remarks:
24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
other:
Remarks:
score of animal number 3
Time point:
other: 0 h
Score:
0
Irritation parameter:
erythema score
Basis:
other:
Remarks:
scores of animal number 1 and 2
Time point:
other: 0 h
Score:
1
Irritation parameter:
erythema score
Basis:
other:
Remarks:
scores of animal number 4 and 6
Time point:
other: 0 h
Score:
2
Irritation parameter:
erythema score
Basis:
other:
Remarks:
score of animal number 5
Time point:
other: 0 h
Score:
3
Irritation parameter:
edema score
Basis:
other:
Remarks:
scores of animal number 1, 2 and 3
Time point:
other: 0 h
Score:
0
Irritation parameter:
edema score
Basis:
other:
Remarks:
scores of animal number 4, 5 and 6
Time point:
other: 0 h
Score:
1
Irritant / corrosive response data:
The test substance was found to induce some skin irritation effects. After 24 hours exposure very slight to moderate erythema and very slight edema was observed. Dermal effects observed 48 hours after patch removal were very slight or well-defined erythema, slight scaliness and very slight edema.

Any other information on results incl. tables

To be able to derive a CLP classification from skin irritation test results, normally the 24, 48 and 72 hours timepoints (after patch removal) for erythema and edema are used. In this study only the 48 hours timepoint is available for evaluation. As supporting evidence the reading directly after removal of the patch is available (0 hours timepoint) and can be considered the worst-case effect. Based on the available eythema and edema scores and the longer exposure period (24 instead of 4 hours), it is concluded that interpretation for CLP purposes is possible with the current test.

Applicant's summary and conclusion

Interpretation of results:
other: not skin irritating
Remarks:
Based on CLP criteria (EC 1272/2008 and its updates)
Conclusions:
Hyacinth body is not an irritant to skin, according to OECD 404.
Executive summary:

The skin irritation potential of Hyacinth body was tested in vivo using 12 New Zealand white rabbits (6 with intact skin and 6 with abraded skin). Study was performed similar to OECD 404 with some deviations on exposure time and observation period and therefore a Klimisch 2 rating was assigned. The test material was applied on the skin under a surgical patch. After an exposure period of 24 hours the patches were removed. Only testing results of 6 animals with intact skin are considered useful for evaluation of skin irritation. The animals were observed only at 48 hours after patch removal and no observations were done at time points of 24 and 72 hours. Effects observed directly upon patch removal were limited. Regarding erythema, 1 animal scored 3, 2 animals scored 2, 2 animals scored 1 and 1 animal scored 0, and regarding edema, 3 animals scored 1 and 3 animals scored 0. The dermal effects observed at 48 hours after patch removal were decreased to none to moderate erythema (1 animal scored 2, 2 animals scored 1 and 3 animals scored 0) and none to slight edema (1 animal scored 1 and 5 animals scored 0). Directly after patch removal only the erythema score for one animal was above the classification threshold (score 3). Although the study was not continued until the complete disappearance of the effects, the effects decreased largely within the 48 hours after patch removal. Given the longer exposure period of 24 instead of 4 hours and the test results obtained, it can be concluded that Hyacinth body is not an irritant to skin.