9-Octadecenedioic acid

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

29 Jun - 7 Aug 2015

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles. The analytical purity of the test substance was not specified.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Repeat Insult Patch Test (RIPT) with 107 volunteers (104 completed), simple blind, performed according to the 'Test Clinique Final de Sécurité d'un produit cosmétique en vue de confirmer son absence de potentiel sensibilisant cutané retardé: recommandations aux promoteurs de recherche et aux prestataires de service' by the French Agency for the safety of health products (ASSAPS).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

802-122-7

EC Number:

802-122-7

IUPAC Name:

802-122-7

Constituent 2

Reference substance name:

Octadec-9-enedioic acid

IUPAC Name:

Octadec-9-enedioic acid

Details on test material:

- Name of test material (as cited in study report): NEWDIOIC 12358
- Physical state: white emulsion with grains
- Analytical purity: no data
- Lot/batch No.: B1

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Remarks:

an internal committee approved the study protocol prior to study start

Subjects:

- Number of subjects exposed: 104 (3/107 subjects withdrew from the study, no subjects were excluded)
- Sex: 23 males, 84 females
- Age: 19 - 68 years (mean: 56 years)
- Other: subjects had skin phototype (Fitzpatrick) I-IV.

Clinical history:

- History of allergy or casuistics for study subject or populations: Any subject exhibiting or with a history of any dermatological or other medical or physical conditions that would preclude dermal application of the test substance was excluded from the study (see 'Any other information on materials and method incl. tables' for a complete list of inclusion/exclusion criteria).

Controls:

An occlusive patch containing 20 µL distilled water was applied adjacent to the treatment patch.

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: repeated insult patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Finn Chamber, 50 mm² aluminium cup kept in place with a hypoallergenic adhesive (Scanpor)
- Vehicle / solvent: glycerine
- Concentrations: 30%
- Volume applied: 20 µL
- Testing/scoring schedule: 9 induction exposures were performed over a period of 3 weeks; 3 inductions/week (Monday,Wednesday, Friday). A patch applied on Monday/Wednesday remained in place for 48 ± 4 h, while a patch applied on Friday remained in place for 72 ± 4 h. The site was scored for skin irritation after patch removal, when the subject returned for the next induction patch. Induction patches were applied to the same site on the upper back. The challenge was performed at least two weeks after the last induction. One challenge patch was applied to the induction site and one challenge patch was applied to a new site and remained in place for 48 ± 4 h. The sensitisation reaction at the challenge sites was assessed 0 and 48 h after patch removal.
- Removal of test substance: no data
- Other: the test site was wiped clean with a cotton pad prior to application

EXAMINATIONS
- Grading/Scoring system:
Erythema:
0 = no visible reaction
0.5 = very slight erythema
1 = mild erythema
2 = moderate erythema
3 = severe erythema, induration, vesicles
4 = caustic effect, erosive aspect and/or necrotic aspect
Allergic reaction: according to the ICDRG scale
IR: irritation reaction
-: no allergic reaction
?+: doubtful reaction
+: weak positive reaction
++: strong positive reaction
+++: extreme positive reaction
Additional observations recorded: relevant skin reactions like desquamation, dryness, papules, vesicles, spreading beyond the patch area, itching, fissuring, scabs, pruritus, pustules.

Results and discussion

Results of examinations:

During the induction phase, none of the 104 subjects exhibited allergic reactions, erythema or any other skin irritation reactions. Following the challenge treatment, no allergic reactions or irritation reactions were noted at any treatment site, nor at any control site. The test material did not induce skin sensitisation in any of the 104 subjects.

Applicant's summary and conclusion

Conclusions:

The test substance did not cause skin sensitisation in any of the subjects under the conditions of the study.