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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 17 November to 24 December 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Controlled clinical study - the detailed composition of the test solution, which remained private company property, is not reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
skin sensitisation
Principles of method if other than guideline:
Modification of the Repeated Insult Patch Test of Draize
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: aqueous solution
Details on test material:
- Name of test material (as cited in study report): Mackam LSB-50
- Physical state: no data
- Composition of test material, percentage of components: Water 51-53% - Lauramidopropyl hydroxysultaine 42% - Lauramidopropyl Dimethylamine <0.8% - Sodium chloride 6% - Tetrasodium EDTA 0.04% (composition documented in the product information datasheet, not reported in the study report)
- Lot/batch No.: 101464
- Expiration date of the lot/batch: Not specified
- Storage condition of test material: Not reported

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 54
- Sex: male and female
- Age: 17 to over 75 years old
- Race: Not specified
- Demographic information: not specified
- Known diseases: Anyone in poor health, with any visible skin disease which might be confused with a skin reaction from the test material, under topical or systemic steroids and/or antihistamines medication was excluded. Pregnant or nursing females were also excluded from the panel.
Ethical approval:
confirmed and informed consent free of coercion received
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
not specified
Details on exposure:
Prior to the initiation of this study, the Analytical Department prepared the test material as a 12% dilution, using distilled water and adjusted the pH to
6.03.Test material was applied to each panelist as semiocclusive patches. Patches were applied three times per week (e.g., Monday, Wednesday, and Friday) for a total of nine applications. The site was marked to ensure the continuity of patch application. Following supervised removal and scoring of the first Induction patch, participants were instructed to remove all subsequent Induction patches at home, twenty-four hours after application.
The upper back between the scapulae served as the treatment area. Approximately 0.2 ml of the test material, or an amount sufficient to cover the contact surface, was applied to the 1" x 1" absorbent pad portion of a clear adhesive dressing.
With the exception of the first supervised Induction Patch reading, if any test site exhibited a moderate (2-level) reaction during the Induction Phase, application was moved to an adjacent area. Applications were discontinued for the remainder of this test phase, if a moderate (2-level) reaction was observed on this new test site. Applications would also be discontinued if marked (3-level) or severe (4-level) reactivity was noted. Rest periods consisted of twenty-four hours following each Tuesday and Thursday removal, and forty-eight hours following each Saturday removal.
Examinations:
Approximately two weeks after the final Induction patch application, a Challenge patch was applied to a virgin test site adjacent to the original Induction patch site, following the same procedure described for Induction. The patch was removed and the site scored at the clinic twenty-four and forty-eight hours post-application, due to a holiday occurring during that week.

Evaluation Criteria (Erythema and additional Dermal Sequelae):
Erythema was scored numel:ically according to this key.
0 = No visible skin reaction
0.5/+ = Barely perceptible
1 = Mild
2 = Moderate
3 = Marked
4 = Severe
If present, additional Dermal Sequelae were indicated by the appropriate letter code and a numerical value for severity.
E= Edema
D= Dryness
S= Staining
P= Papules
V= Vesicles
B= Bullae
U= Ulceration
Sp= Spreading
Medical treatment:
Not applicable

Results and discussion

Clinical signs:
Observations rcmained negative throughout the test interval
Results of examinations:
Score for erythema was zero in all subjects of the panellist at any treatment time point (induction and challenge phase).
Effectivity of medical treatment:
Not applicable

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, test material, Mackam LSB-50 as a 12% solution in distilled water did not indicate a potential for dermal irritation or allergic contact sensitization.
Executive summary:

A Repeated Insult Patch Test using semioccluded patches was carried out on 54 male and female healthy volunteers with Mackam LSB50 diluted at 12% in distilled water.

The induction phase consisted in 9 topical applications (3 applications/weeks) of the test item in the upper back region between the scapulae. Approximately two weeks after the final Induction patch application, a Challenge patch was applied to a virgin test site adjacent to the original Induction patch site. The patch was removed and the site scored 24 and 48 hours post-application.

The test item was non-irritating following a single application for 24 hours (erythema score = 0 in all subjects, absence of any dermal reaction).

There was no indication of contact sensitization.

Repeated dermal application of a 12% aqueous solution of Mackam LSD50 to 54 healthy human volunteers under semiocclusive conditions did not result in any skin reaction indicative of irritation or sensitization.