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EC number: 931-534-0 | CAS number: 68439-57-6
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-04-09 - 2008-05-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well document and acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Repeated occlusive patch test on human volunteers
- GLP compliance:
- yes
- Remarks:
- GCP
Test material
- Reference substance name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- EC Number:
- 931-534-0
- Cas Number:
- 68439-57-6
- Molecular formula:
- C(4+2n)H(9+4n)SO4Na C(4+2n)H(7+4n)SO4Na n = 5-6
- IUPAC Name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- Reference substance name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- IUPAC Name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- Test material form:
- other: aqueous formulation
- Details on test material:
- - Name of test material (as cited in study report): BIO-TERGE AS-40 and BIO-TERGE AS-40-2
- Physical state: Transparent liquid
- Analytical purity: concentration tested: 04-09-08 to 04-14-081: 2%, 04-15-08 to 05-23-08: 1%
Constituent 1
Constituent 2
Method
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Subjects:
- - Number of subjects exposed: 52
- Sex: 5 male, 47 female
- Age: Mean age 49 years
- Race: 38 caucasian, 9 asian, 5 hispanic - Controls:
- The test will include a positive (1% Sodium lauryl sulfate, SLS) and a negative (blank) control patch. SLS will be provided by Stephens.
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: repeat insult human patch test (epicutaneous test)
ADMINISTRATION
- Type of application: 9x occlusive
- Vehicle / solvent: water
- Concentrations: 1% solution
- Volume applied: 50 µL
EXAMINATIONS
- Grading/Scoring system:
Induction grading scale:
Erythema and Elevated Responses
0 No evidence of irritation
1 Minimal erythema, barely perceptible
2 Definite erythema, readily visible; or minimal edema; or minimal papular response
3 Erythema and papules
4 Definite edema
5 Erythema, edema, and papules
6 Vesicular eruption
7 Strong reaction spreading beyond test site
Effects on Superficial Layers of the skin
A 0 Slight glazed appearance
B 1 Marked glazing
C 2 Glazing with peeling and cracking
D 3 Glazing with fissures
E 3 Film of dried serous exudate covering all or portion of the patch site
F 3 Small petechial erosions and/or scabs
W Weeping - evidence of release of fluid from a vesicular or bullons reaction
T Marked reaction to adhesive (patch relocated)
X Succeeding patch not applied and succeeding grade is for residual reaction
R Subject did not remove the patch at the assigned time
L-1 Subject report of lost patch (came off) during first 12 hours of exposure
L-2 Subject report of lost patch (came off) between 12 and 48 hours of exposure
(-) Subject absent
Challenge grading scale:
Erythema Scale: This scale was used only for grading degree of erythema (redness).
0 No visible erythema
1 Mild erythema (faint pink to definite pink)
2 Moderate erythema (definite redness)
3 Severe erythema (very intense redness)
Designation for Elevated Responses: Edema, papules, vesicles, and bullae, it present, were graded as independent responses.
E Edema - definite swelling
P Papules - small, red, solid elevations; surface of reaction has granular feeling
V Vesicies - small, circumscribed elevations having translucent surfaces so that fluid is visible (blister-like); vesicles are no larger than 0.5 cm in diameter
B Bullse - vesicles with a diameter >0.5 cm; vesicles may coalesce to form one or a few large blisters that till the patch site
Other Response Characteristics
S Spreading - evidenice of the reaction beyond the chamber area (does not include obvious signs of leakage of test material away from chamber)
W Weeping - evidence of release of fluid from a vesicular or bullous reaction
Other Recording Designations
T Marked reaction to adhesive
R Subject did not remove the patch at the assigned time
L-1 Subject report of lost patch (came off) during first 12 hours of exposure
L-2 Subject report of lost patch (came off) between 12 and 48 hours of exposure
(-) Subject absent
- Statistical analysis:
Mean cumulative irritation scores were compared among the sites using ANOVA with pairwise comparisons (Fishers LSD). All differences are considered significant at the p<=0.05 level
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed:
Induction 1: 6/52 pos
Induction 2: 11/52 pos
Induction 3: 18/52 pos
Induction 4: 25/52 pos
Induction 5: 21/52 pos
Induction 6: 15/52 pos
Induction 7: 19/52 pos
Induction 8: 11/52 pos
Induction 9: 11/52 pos
48h after challenge at induction site: 24/52 pos
96h after challenge at induction site: 21/52 pos
48h after challenge at alternative site: 27/52 pos
96h after challenge at alternative site: 27/52 pos
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 27/52
- Number of subjects with negative reactions: 25/52
- Number of subjects with irritating reactions: 27/52
Under the conditions of this test the test material did not induce delayed contact sensitisation (allergic contact dermatitis) in any of the subjects, but has a clear irritation potential to human skin.
Any other information on results incl. tables
Table 1: Irritation scores at the study stages
Study stage |
Subjects with positive reactions/all subjects |
Induction 1 |
6/52 |
Induction 2 |
11/52 |
Induction 3 |
18/52 |
Induction 4 |
25/52 |
Induction 5 |
21/52 |
Induction 6 |
15/52 |
Induction 7 |
19/52 |
Induction 8 |
11/52 |
Induction 9 |
11/52 |
48h after challenge at induction site |
24/52 |
96h after challenge at induction site |
21/52 |
48h after challenge at alternative site |
27/52 |
96h after challenge at alternative site |
27/52 |
Under the exposure conditions of this test the test material did not induce delayed contact sensitisation (allergic contact dermatitis) in any of the subjects.
BioTerge-AS40 was not sensitising for humans but has a clear irritation potential to human skin.
Applicant's summary and conclusion
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