Reaction product of stearic acid and diglycerol

Sensitisation data (human)

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

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

Test material information

Constituent 1

Test material form:

solid

Specific details on test material used for the study:

SAMPLE IF 3
BATCH LS080611B

Method

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 and discussion

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

Any other information on results incl. tables

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

Applicant's summary and conclusion

Conclusions:

ESTER B is not irritant.