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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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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:
with 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:
72 hours
Number of animals:
12 animals - 6 with intact skin and 6 with abraded skin (results for abraded skin are disregarded).
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 from the start of exposure (so directly after exposure, at time point 0 h after patch removal) and after 72 hours (so at time point 48 h 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:
animal #1
Time point:
other: 0 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 0 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 0 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 0 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 0 h
Score:
3
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 0 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 0 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 0 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 0 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 0 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 0 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 0 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Remarks on result:
other:
Remarks:
24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Remarks on result:
other:
Remarks:
24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritant / corrosive response data:
The test substance caused moderate skin irritation. Its dermal effects observed after 24 hours of exposure (so at time point 0 h after patch removal) generally consisted of very slight to moderate erythema and very slight edema. Dermal effects observed after 72 hours after exposure (so at time point 48 h after patch removal) consisted of 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), which can be considered the worst-case effect. Based on the available eythema and edema scores and given the longer exposure period (24 instead of 4 hours), it is concluded that classification for CLP purposes can be assessed with the current test as it can be seen as a worst-case.

Applicant's summary and conclusion

Interpretation of results:
other: Not a skin irritant
Remarks:
Based on EU CLP criteria (EC 1272/2008 and its updates)
Conclusions:
Hyacinth body was tested in a study similar to OECD TG 404 and based on the results it was concluded not to be a skin irritant.
Executive summary:

The skin irritation potential of Hyacinth body was tested in an in vivo study performed similar to OECD TG 404 with some deviations on exposure time and observation period and therefore a Klimisch 2 rating was assigned. In this study, 12 New Zealand white rabbits were used, 6 with intact skin and 6 with abraded skin. 24 hours prior to dosing the hair was removed from the back with a clipper. 0.5 mL testing material was applied on the skin under a surgical patch 1x1 inch. After the exposure period of 24 hours patches were removed. Only testing results of animals with intact skin were considered for evaluation of skin irritation. Observations made directly upon patch removal are treated as time point 0 h and the observations made at 48 hours after patch removal are treated as time point 48 h. The 24 h and 72 h time points were not scored, therefore the only 48 h results could be taken into consideration. Effects observed upon patch removal (so at time point 0 h) were limited. Slight to moderate erythema was observed (1 animal with score 3, 2 animals with score 2, 2 animals with score 1 and 1 animal with score 0) and none to slight edema (3 animals with score 1 and 3 animals with score 0). This was not sufficient to consider the substance a skin irritant. The decreased presence of dermal effects observed 48 hours after patch removal supports this finding. A slight to moderate erythema was then observed (1 animal scored 2 and 2 animals scored 1), none to slight edema (1 animal scored 1 and 5 animals scored 0) and a slight scaliness. Under the conditions of this test, some erythema and edema effects were observed directly after patch removal but only an erythema score for one animal was above the classification threshold. When taking the results from 48 h, though, none of the animals exceeded the score 2.3 for erythema or oedema (which is a criterion for EU CLP classification). 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.

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