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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Skin sensitisation study over a 6 weeks period involving three phases: (1) Induction, (2) Rest, (3) Challenge. The induction phase consisted of 9 consecutive applications of the test material for 24 hours and subsequent evaluations. The challenge phase was initiated after the rest period of 14 days in the sixth week of the study. Test substance was again applied for 24 hours and reactions graded 48 and 72 hours after application. A rechallenge was performed whereever there was evidence of possible sensitisation.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
EC Number:
239-032-7
EC Name:
Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
Cas Number:
14960-06-6
Molecular formula:
C18H35NO4.Na
IUPAC Name:
sodium 3-[(2-carboxyethyl)(dodecyl)amino]propanoate
Specific details on test material used for the study:
- Name of test material (as cited in study report): Sodium Lauriminodipropionate, MV#2764-178
- Substance type: foaming face wash formulation
- Physical state: test material is a foaming face wash containing 7.34% Deriphat 160C which is a 30 % solution of Sodium Laurimindiproprionate (MV#2764-178 - white pearlized lotion (tested as 2.0% (w/v) solution in distilled water)
- Analytical purity: contains 2.2 % of the test substance
- Composition of test material, percentage of components:
- Storage condition of test material: at room temperature

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 110
- Sex: 12 male, 98 female
- Age: 18 to 25 (13 subject); 26 to 35 (17 subject); 36 to 45 (33 subjects); 46 to 55 (27 subjects); 56 to 65 (12 subjects); over 65 (8 subjects)
- Race: 17 caucasian, 92 hispanic, 1 other
Clinical history:
- History of allergy or casuistics for study subject or populations: only subjects with no systemic or dermatological disorder were considered for the study
Controls:
none
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: non-porous, plastic film adhesive bandage with a 2 cm x 2 cm Webril pad affixed with hypoallergenic tape such as Scanpor or Micropore as needed
- Vehicle / solvent: water
- Concentrations: 2.0 % (w/v) solution for MV#2764-178
- Volume applied: 0.2 mL
- Testing/scoring schedule: 9 induction pads are consecutively applied each for 24 hours, reactions are scored 48 hours after application (if patch was applied on a friday, subjects removed the patch 24 hours later and reactions were scored the following monday (72 hours after application)); after scoring the next patch was applied; the induction phase is followed by a 2 week resting period, after which the challenge pads are applied to previously unexposed sites, the patches are again removed after 24 hours and reactions are scored 48 and 72 hours after application. In case of possible evidence for sensitization a rechallenge is conducted (occlusive and semiocclusive) 1 or two weeks after challenge, patches are again applied for 24 hours and scoring is done 48, 72 and 96 hours after application.
- Removal of test substance: removal of patch

EXAMINATIONS
Grading/Scoring system:
- no reaction
? doubtful response, barely perceptible erythema, only slightly different from surrounding skin
+ definite erythema, no edema
+* definite erythema, minimal or doubtful edema
++ definite erythema, definite edema
+++ definite erythema, definite edema & vesiculation
D or d damage to epidermis: d = drying/scaling; D = oozing, crusting and/or superficial erosions

Results and discussion

Results of examinations:
Only two subjects showed erythema and slight edema during the induction period, all other subjects were without reactions

Any other information on results incl. tables

Table1: Summary of Reaction Data

   Induction                          Challenge   
 Grade  1  2  3  4  5  6  7  8  9  1  2
 -  106  105  103  106  105  99  101  92  94  102  103
 ?  0  1  1  1  2  2  2  8  10  1  1
 +  0  0  0  0  0  0  0  0  0  0  0
 +*p  0  0  0  0  0  0  1  0  0  0  0
 ++  0  0  0  0  0  0  0  0  0  0  0
 +++  0  0  0  0  0  0  0  0  0  0  0
 +*pD  0  0  0  0  0  0  0  1  0  0  0
 NP  0  0  0  0  0  0  0  0  0  0  0
 total readings  106  106  104  107  107  101  104  101  104  103  104
 # absent  4  4  6  3  3  9  6  9  6  7  6
 not applied  0  0  0  0  0  0  0  0  0  0  0
 patch dislodged  0  0  0  0  0  0  0  0  0  0  0
 total subjects  110  110  110  110  110  110  110  110  110  110  110

Applicant's summary and conclusion

Conclusions:
Under the conditions employed in this study, there was no evidence of sensitization for the substance tested.

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