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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
48 hour closed patch test under occlusion
Type of information:
experimental study
Remarks:
48 hour closed patch test under occlusion
Adequacy of study:
key study
Study period:
2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose for cross-reference:
exposure-related information
Reference
Endpoint:
sensitisation data (humans)
Remarks:
48 hour closed patch test under occlusion
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Type of sensitisation studied:
skin
Study type:
study with volunteers
Qualifier:
according to guideline
Guideline:
other: 48 hour closed patch test under occlusion
Deviations:
not specified
Principles of method if other than guideline:
This study assesses the potential side effects (skin erythema and oedema reactions) that may occur after applying a cosmetic product to evaluate whether the topical product is safe for consumer use.
The skin area involved in the product application (dorsal) is cleaned with a 70% alcoholic solution to make it more
sensitive to product application. The product is applied non diluted by using the Finn Chamber, a 7 mm diameter
aluminium disk. The Finn Chamber is fixed to the skin with a tape already been tested for its safety that ensure the
occlusive application of the product.
Applied quantity is sufficient to fill the chamber without overflowing from it when applied on the skin. The product is left in contact with the skin surface for 48 hours. The cutaneous reactions are analysed 15 minutes, one hour and 24 hours after Finn Chamber removal. A Finn Chamber containing a blotting paper disk soaked with distilled water is applied and used as a negative control.
Skin reactions are evaluated 15 minutes, 1 hour and 24 hours after patch removal according to the scores reported in table 1, that describes the severity of erythema, oedema or other types of skin irritation
GLP compliance:
no
Specific details on test material used for the study:
SAMPLE IF 3
BATCH LS080611B
Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 25
- Sex: M and F
- Age: 18-60 years old
Controls:
A Finn Chamber containing a blotting paper disk soaked with distilled water is applied and used as a negative control
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: The product is applied non diluted by using the Finn Chamber, a 7 mm diameter aluminium disk. The Finn Chamber is fixed to the skin with a tape
- Vehicle / solvent: not used
- Testing/scoring schedule and removal: The product is left in contact with the skin surface for 48 hours. The cutaneous reactions are analysed 15 minutes, one hour and 24 hours after Finn Chamber removal.
- Other: A Finn Chamber containing a blotting paper disk soaked with distilled water is applied and used as a negative control.

EXAMINATIONS
- Grading/Scoring system: Skin reactions are evaluated 15 minutes, 1 hour and 24 hours after patch removal according to the scores 0-4 where zero represent a lightly erythema, 2 Clearly visible erythema, 3 moderate erythema and 4 correspond to serious erythema.
- Statistical analysis: For each experimental time Mean Irritation Index (IIM) is calculated by adding erythema mean value and oedema mean value. The tested product is then classified following table which is based on the Mean Irritation Index.

Mean Irritation Index (IIM) / Product classification
< 0,5 / non irritating
from 0.5 to 2.0 / slightly irritating
from 2.0 to 5.0 / moderately irritating
from 5.0 to 8.0 / highly irritating
Results of examinations:
SYMPTOMS
-

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 4
- Number of subjects with negative reactions: 21

Anyone shown reactions after 24h. Three subjects shown erythema after 15min and after 1h from the application. Only one female shown also oedema after 15 min and after 1h from the application.


Potential skin irritation of the product has been assessed according to the amended Draize classification. The test substance is considered as NOT IRRITANT

OEDEMA AND ERYTHEMA REACTIONS

  sex ERYTHEMA 15min OEDEMA 15 min ERYTHEMA 1h OEDEMA 1h ERYTHEMA 24h OEDEMA 24h
R047H  F 0 0 0 0 0 0
S030E  F 0 0 0 0 0 0
D046G  M 0 0 0 0 0 0
S093S  M 0 0 0 0 0 0
D041L  F 0 0 0 0 0 0
L048L  F 0 0 0 0 0 0
G080M  M 0 0 0 0 0 0
C196S  F 0 0 0 0 0 0
S157C  F 0 0 0 0 0 0
C076C  M 0 0 0 0 0 0
B078M  F 1 0 1 0 0 0
V056C  M 1 0 1 0 0 0
F026M  F 1 1 1 1 0 0
G076M  F 0 0 0 0 0 0
R067L  F 0 0 0 0 0 0
M115O  F 0 0 0 0 0 0
G171A  M 1 0 1 0 0 0
S179A  M 0 0 0 0 0 0
B083B  F 0 0 0 0 0 0
P068M  F 0 0 0 0 0 0
L092P  F 0 0 0 0 0 0
G032T  F 0 0 0 0 0 0
L078N  F 0 0 0 0 0 0
D101M  M 0 0 0 0 0 0
P093C  F 0 0 0 0 0 0
Conclusions:
ESTER B is not irritant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 48 hour closed patch test under occlusion
Deviations:
not specified
Principles of method if other than guideline:
This study assesses the potential side effects (skin erythema and oedema reactions) that may occur after applying a cosmetic product to evaluate whether the topical product is safe for consumer use.
The skin area involved in the product application (dorsal) is cleaned with a 70% alcoholic solution to make it more
sensitive to product application. The product is applied non diluted by using the Finn Chamber, a 7 mm diameter
aluminium disk. The Finn Chamber is fixed to the skin with a tape already been tested for its safety that ensure the occlusive application of the product.
Applied quantity is sufficient to fill the chamber without overflowing from it when applied on the skin. The product is left in contact with the skin surface for 48 hours. The cutaneous reactions are analysed 15 minutes, one hour and 24 hours after Finn Chamber removal. A Finn Chamber containing a blotting paper disk soaked with distilled water is applied and used as a negative control.
Skin reactions are evaluated 15 minutes, 1 hour and 24 hours after patch removal according to the scores reported in table 1, that describes the severity of erythema, oedema or other types of skin irritation
GLP compliance:
no

Test material

Constituent 1
Test material form:
solid
Specific details on test material used for the study:
SAMPLE IF 3
BATCH LS080611B

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
25 humans volunteers
Time point:
other: 15 minutes
Score:
0.16
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
25 humans volunteers
Time point:
other: 1 hour
Score:
0.16
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
25 humans volunteers
Time point:
24 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
25 humans volunteers
Time point:
other: 15 minutes
Score:
0.04
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
25 humans volunteers
Time point:
other: 1 hour
Score:
0.04
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
25 humans volunteers
Time point:
24 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
non irritant

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Conclusions:
non irritant
Executive summary:

Human patch test do not show evidence of skin irritation

Details on HPT on Ester B are available in Sect. 7.10.4

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