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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
HRIPT
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: HRIPT
Principles of method if other than guideline:
A unicentric, blind, noncomparative clinical study to evaluate primary
dermal irritability, accumulated and dermal sensitization, in order to prove
the topical compatibility of the investigational product. The study was
performed under maximized conditions, in which dressings containing the
product were applied on the back of the participants to prove the absence
of irritation and allergy potential. The practical part of the study lasted six
weeks, three weeks of application of the product, two weeks of rest of the
participants and a new application of the product in virgin area, in the
sixth week (challenge). The readings were performed according to the
reading scale recommended by the International Contact Dermatitis
Research Group (ICDRG). Dermatological assessments were performed at
the beginning and end of the study, or when there was evidence of a
positive or adverse reaction.
GLP compliance:
yes
Remarks:
Good Clinical Practices
Type of study:
patch test

Test material

Constituent 1
Chemical structure
Reference substance name:
Diethyl sebacate
EC Number:
203-764-5
EC Name:
Diethyl sebacate
Cas Number:
110-40-7
Molecular formula:
C14H26O4
IUPAC Name:
diethyl sebacate
Test material form:
liquid

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
other: Primary Dermal Irritability
Hours after challenge:
96
Group:
test chemical
Dose level:
1 patch
No. with + reactions:
0
Total no. in group:
51
Clinical observations:
None
Key result
Reading:
other: Accumulated Dermal Irritability (ADI)
Hours after challenge:
288
Group:
test chemical
Dose level:
1 patch
No. with + reactions:
0
Total no. in group:
51
Clinical observations:
None
Reading:
other: Dermal Sensitization (DS)
Hours after challenge:
288
Group:
test chemical
Dose level:
1 patch
No. with + reactions:
0
Total no. in group:
51
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
• No potential for Primary Dermal Irritation was observed;
• No potential for Accumulated Dermal Irritation was observed;
• No Dermal Sensitization potential was observed.
According to the recommendation of the Safety Assessment Guide for
Cosmetic Products (ANVISA, 2012 - 2nd Edition), the product may be
declared Dermatologically Tested.
Executive summary:

TITLE

EN20-0222-01 - EVALUATION OF PRIMARY DERMAL IRRITABILITY,

ACCUMULATED DERMAL IRRITABILITY AND DERMAL SENSITIZATION

STUDY CODE

EN20-0222-01

SPONSOR BIOSYNTHIS

NAME OF THE INVESTIGATIONAL PRODUCT BIOSOLV DES

REFERENCE CODE OF THE INVESTIGATIONAL

PRODUCT

NOT CONCERNED

BATCHE OF THE INVESTIGATIONAL

PRODUCT

1727003

STUDY OBJECTIVE

To check for the absence of irritation potential (primary and accumulated

dermal irritability) and allergy (sensitization) of the investigational

product.

METHOD

A unicentric, blind, noncomparative clinical study to evaluate primary

dermal irritability, accumulated and dermal sensitization, in order to prove

the topical compatibility of the investigational product. The study was

performed under maximized conditions, in which dressings containing the

product were applied on the back of the participants to prove the absence

of irritation and allergy potential. The practical part of the study lasted six

weeks, three weeks of application of the product, two weeks of rest of the

participants and a new application of the product in virgin area, in the

sixth week (challenge). The readings were performed according to the

reading scale recommended by the International Contact Dermatitis

Research Group (ICDRG). Dermatological assessments were performed at

the beginning and end of the study, or when there was evidence of a

positive or adverse reaction.

POPULATION SAMPLE

Number of participants screened = 56;

Number of participants selected = 55;

Number of participants who completed the study = 51;

Number of participants with data used in conclusion = 51.

AREA OF APPLICATION : Back

DURATION OF THE STUDY : 13.APR.2020 to 21.MAY.2020

RESPONSIBLE RESEARCHER

Dr. Sérgio Schalka

Médico dermatologista

CRM 70.148 - SP

Link do currículo lattes: http://lattes.cnpq.br/5104492141816914

ETHICAL CONSIDERATIONS AND QUALITY

CONTROL

The study was conducted in accordance with the guidelines of the Good

Clinical Practices. Quality control runs at each step of the method.

RESULTS

• After the study period of Primary Dermal Irritability, none of the

52 participants who completed this stage had skin reaction;

• After the Accumulated Dermal Irritability period, none of the 51

participants who completed this stage had skin reaction;

• After the period of the Dermal Sensitization study, none of the 51

participants who completed this stage had skin reaction.

CONCLUSION

• No potential for Primary Dermal Irritation was observed;

• No potential for Accumulated Dermal Irritation was observed;

• No Dermal Sensitization potential was observed.

According to the recommendation of the Safety Assessment Guide for

Cosmetic Products (ANVISA, 2012 - 2nd Edition), the product may be

declared Dermatologically Tested.