Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Currently viewing:

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Publication on non-guideline study, classification on the basis of the available results is not possible.

Data source

Reference
Reference Type:
publication
Title:
Cutaneous response to irritants
Author:
Santucci, C., Cannistraci, C., Lesnoni, I., Ferraro, C., Rocco, M., Dell'Anna, L., Giannarelli, D., Cristaudo, A.
Year:
2003
Bibliographic source:
Contact Dermatitis 48: 69-73

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Several substances (including the analogue substance) were tested for their skin irritation potential. They were applied to healthy skin and to skin exhibiting pre-existing dermatitis for the purpose of comparison.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium oleate
EC Number:
205-590-5
EC Name:
Potassium oleate
Cas Number:
143-18-0
Molecular formula:
C18H34O2.K
IUPAC Name:
potassium octadec-9-enoate
Test material form:
other: liquid

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 520
- Sex: male and female
- Age: 8-73 years
- Known diseases:
group 1: 40 healthy subjects (10 men and 30 women)
group 2: 19 mean and 21 women with atopic dermatitis
group 3: 26 men and 31 women with active psoriasis
group 4: 31 men and 93 women with eczema, giving positive patch test responses
group 5: 53 men and 87 women with eczema with no patch test responses
group 6: 21 men and 58 women with active urticaria
group 7: 14 men and 26 women with generalized pruritus
Ethical approval:
not applicable
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
15 µL of the substance (concentration 5 %) were applied to the skin for a duration of 2 days. Two patches were therefore applied to the upper back. Additionally patches were applied to patients with urticaria, these were removed after 30 min.
Examinations:
- Other: the skin was examined and scored according to the following system:
0: no visible reaction
1: erythema
2: erythema with oedema
3: erythema with oedema and papules
4: erythema with vesicles or bullae
Readings were performed one hour after patch removal (after 2 days of exposure) and immediately after removal of the patches (after 30 min of exposure).
Medical treatment:
none

Results and discussion

Clinical signs:
After 2 days of exposure with the analogue substance positive responses were found in 0.2 % of the test persons. Exposure with the positive controls led to positive reactions in 36 % (BAK), 38 % (SLS) and 1.3 % (DMSO) persons, respectively. Positive responses to both BAK and SLS were seen in 22 %.
Effectivity of medical treatment:
not applicable
Outcome of incidence:
not applicable

Any other information on results incl. tables

Table 1: positive responses to the analogue substance and positive controls

 

healthy

atopic dermatitis

psoriasis

eczema with positive patch test

eczema with negative patch test

urticaria

pruritus

No of subjects

40

40

57

124

140

79

40

analogue substance 5%

neg

neg

neg

1

neg

1

neg

BAK 1 %

17

12

22

50

53

26

11

SLS 1 %

16

13

18

54

56

26

17

DMSO 10 %

1

neg

2

6

2

1

neg

 

Applicant's summary and conclusion