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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:
1978-02
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented based on US CPSC method. Similar to OECD 404 with major but acceptable deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: US CPSC 1500.41
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24 hour exposure, type of occlusion, number of readings, inclusion of abraded skin and no reversibility period included in testing
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibenzyl ether
EC Number:
203-118-2
EC Name:
Dibenzyl ether
Cas Number:
103-50-4
Molecular formula:
C14H14O
IUPAC Name:
[(benzyloxy)methyl]benzene
Details on test material:
- Name of test material (as cited in study report): oxyde de dibenzyle
No further data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
No data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: hair clipped, and abraded/intact skin
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
No further data
Duration of treatment / exposure:
24 hrs
Observation period:
48 hrs after the removal of patch system
Number of animals:
Six
Details on study design:
SCORING SYSTEM: Draize system as required in the US CPSC guideline
No further data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
ca. 1.6
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.66
Max. score:
4
Reversibility:
other: no data
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0.66
Max. score:
4
Reversibility:
other: no data
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0.66
Max. score:
4
Reversibility:
other: no data
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0.83
Max. score:
4
Reversibility:
other: no data
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.66
Max. score:
4
Reversibility:
other: no data
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
other: no data
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0.83
Max. score:
4
Reversibility:
other: no data
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
other: no data
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
>= 0
Max. score:
4
Reversibility:
other: no data - not measured/tested
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
>= 0
Max. score:
4
Reversibility:
other: no data
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Very slight to well-defined erythema with very slight to slight oedema was in the intact and abraded sites of three animals at the 24 hours reading point. Very slight oedema was seen in the abraded site of one other animal. Very slight to well-defined erythema with or without very slight to moderate oedema was seen in two intact and four abraded sites ot the 72 hours reading.
Two animals did not show any observable response to treatment throughout the 72 hours observation period.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Animal Symptoms Toxicological findings Primary irritation score
Intact skin abraded skin
24h 72h 7d 24h 72h 7d
1 Erythema 0 0 - 0 0 - Sum of all erythema and edema values for 24h and 72h divided by 24: PII= 1.6
Edema 0 0 - 0 0 -
2 Erythema 0 0 - 0 0 -
Edema 0 0 - 0 0 -
3 Erythema 0 0 - 0 1 -
Edema 0 1 - 0 1 -
4 Erythema 1 1 - 0 1 -
Edema 1 1 - 0 0 -
5 Erythema 2 2 - 2 2 -
Edema 2 2 - 3 3 -
6 Erythema 1 1 - 2 2 -
Edema 1 1 - 2 2 -

Applicant's summary and conclusion

Executive summary:

The authors tested the primary dermal irritation potential of dibenzyl oxide (CAS n° 103 -50 -4) on rabbits based on a US CPSC guideline section 1500.42. They exposed the abraded and intact back skin of six rabbits to 0.5 mL of raw material under occlusive conditions for 24 hours. Afterwards, the authors scored the effects on the skin based on the Draize system described into the guideline. They consecutively calculated a primary dermal irritation index.

Hence, in the test conditions, the authors found that dibenzyl oxide is a mild irritant to the skin of rabbits. Based on DSD or CLP criteria, no classification can be granted since individual scores are only available for a period limited to 48 hours after the end of exposure. However based on individual scores with intact skin within the first 48 hours, dibenzyl oxide should not be classified.

This study is well documented and based on generally well accepted scientific principles. The US CPSC guideline is strictly followed but since methodologies in this field roughly changed over the years, this evaluation method is considered reliable but considerable deviations to current guidelines should be understood and thus the study should be considered as reliable with restrictions, a Klimisch 2.c study.