3-{2-[2-(3-azaniumylpropoxy)ethoxy]ethoxy}propan-1-aminium di[(2Z)-3-carboxyprop-2-enoate]

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

29 July 2020 - 17 November 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2201

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3-{2-[2-(3-azaniumylpropoxy)ethoxy]ethoxy}propan-1-aminium di[(2Z)-3-carboxyprop-2-enoate]

EC Number:

818-033-1

Cas Number:

1629579-82-3

Molecular formula:

C18H32N2O11

IUPAC Name:

3-{2-[2-(3-azaniumylpropoxy)ethoxy]ethoxy}propan-1-aminium di[(2Z)-3-carboxyprop-2-enoate]

Test material form:

liquid

Details on test material:

CAS Number: 1629579-82-3
EC Number: 818-033-1
Molecular formula: C18H32N2O11

Specific details on test material used for the study:

Test sample name: Olaplex Bond Builder No. 1 (BisaminopropyIDiecoIDimaIeate 20%)

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

Standards for Inclusion in a Study:
- Individuals who were not currently under a doctor’s care.
- Individuals who were free of any dermatological or systemic disorder that would interfere with the results, at the discretion of the Investigator.
- Individuals who were free of any acute or chronic disease that would interfere with or increase the risk of study participation.
- Individuals who completed a preliminary medical history form mandated by BCS and were in general good health.
- Individuals who read, understood and signed an informed consent document relating to the specific type of study.
- Individuals who were able to cooperate with the Investigator and research staff, and were willing to have test materials applied according to the protocol, and complete the full course of the study.

Standards for Exclusion from a Study:
- Individuals who were under 18 years of age.
- Individuals who were currently under a doctor’s care.
- Individuals who were currently taking any medication (topical or systemic) that might mask or interfere with the test results.
- Individuals who had a history of any acute or chronic disease that might interfere with or increase the risk associated with study participation.
- Individuals who were diagnosed with chronic skin allergies.
- Female volunteers who indicated that they were pregnant or nursing.

Clinical history:

Non-inclusion criteria:
- Individuals who were currently taking any medication (topical or systemic) that might mask or interfere with the test results.
- Individuals who had a history of any acute or chronic disease that might interfere with or increase the risk associated with study participation.
- Individuals who were diagnosed with chronic skin allergies.

Controls:

Negative control: DI Water;
Positive control: 2.0% Sodium Lauryl Sulfate Solution

Route of administration:

dermal

Details on study design:

PROCEDURE
- Patch Description: Semi-Occlusive (Olaplex Bond Builder No. 1 (BisaminopropyIDiecoIDimaIeate 20%), diluted to 3% in DI Water)
- Subjects were requested to bathe or wash as usual before arrival at the facility.
- Patches containing the test material were then affixed directly to the skin of the intrascapular regions of the back, to the right or left of the midline and subjects were dismissed with instructions not to wet or expose the test area to direct sunlight.
- Patches remained in place for 48 hours after the first application. Subjects were instructed not to remove the patches prior to their 48 hour scheduled visit. Thereafter, subjects were instructed to remove patches 24 hours after application for the remainder of the study.
- This procedure was repeated until a series of nine (9) consecutive, 24-hour exposures had been made three (3) times a week for three (3) consecutive weeks.
- Prior to each reapplication, the test sites evaluated by trained laboratory personnel.
- Following a 10-14 day rest period a retest/challenge dose was applied once to a previously unexposed test site. Test sites were evaluated by trained laboratory personnel 48 and 96 hours after application.
- In the event of an adverse reaction, the area of erythema and edema were measured. Edema is estimated by the evaluation of the skin with respect to the contour of the unaffected normal skin.
- Subjects were instructed to report any delayed reactions that might occur after the final reading.
- Clients will be notified immediately in the case of an adverse reaction and a determination is made as to treatment program if necessary.

EQUIPMENT
Test materials to be tested under occlusive conditions were placed on an 8—millimeter aluminum Finn Chamber® (Epitest Ltd. Oy, Tuusula, Finland) supported on Scanpor® Tape (Norgesplaster A/S, Kristiansand, Norway) or an 8—millimeter filter paper coated aluminum Finn Chamber® AQUA supported on a thin flexible transparent polyurethane rectangular film coated on one side with a medical grade acrylic adhesive, consistent with adhesive used in state-of-the-art hypoallergenic surgical tapes or a 7mm lQ-ULTRA® closed cell system which is made of additive-free polyethylene plastic foam with a filter paper incorporated (It is supplied in units of 10 chambers on a hypoallergenic non woven adhesive tape; the width of the tape is 52mm and the length is 118mm) or other equivalents.
Test materials to be tested under semi-occlusive conditions were placed on a test strip with a Rayon/Polypropylene pad or on a 7.5mm filter paper disc affixed to a strip of hypoallergenic tape (Johnson & Johnson 1 inch First Aid Cloth Tape).
Test materials to be tested in an open patch were applied and rubbed directly onto the back of the subject.
Approximately 0.03 mL of the test material was used for the study. Liquid test material was dispensed on a 7.5mm paper disk, which fit in the Finn Chamber.

SCORING
Scoring scale and definition of symbols shown below are based on the scoring scheme according to the International Contact Dermatitis Research Group scoring scale [RietscheL R.L. Fowler, J.F., Ed., Fisher’s Contact Dermatitis (fourth ed.). Baltimore, Williams & Wilkins, 1995] listed below:
0 - no reaction (negative)
1 - erythema throughout at least % of patch area
2 - erythema and induration throughout at least % of patch area
3 - erythema, induration and vesicles
4 - erythema, induration and bullae
D - Site discontinued
Dc - Subject discontinued voluntarily
Dcl - Subject discontinued per Investigator
NOTE: Clinical evaluations are performed by a BCS investigator or designee trained in the clinical evaluation of the skin. Whenever feasible, the same individual will do the scoring of all the subjects throughout the study and will be blinded to the treatment assignments and any previous scores.

Results and discussion

Results of examinations:

No adverse reactions of any kind were reported during the course of this study.

There was one (1) subject with a Grade 3 reaction, two (2) subjects with a Grade 2 reaction, and twenty-eight (28) subjects with a Grade 1 reaction to the positive control (2.0% Sodium Lauryl Sulfate Solution).

No subjects showed any signs of reaction to the negative control (DI Water).

Applicant's summary and conclusion

Conclusions:

Under the conditions of the study, there was no indication of a potential to elicit dermal irritation or sensitization (contact allergy) noted for Olaplex Bond Builder No. 1 (BisaminopropyIDiecoIDimaIeate 20%)

Executive summary:

Patches remained in place for 48 hours after the first application. Thereafter, subjects were instructed to remove patches 24 hours after application for the remainder of the study. This procedure was repeated until a series of nine (9) consecutive, 24-hour exposures had been made three (3) times a week for three (3) consecutive weeks. Following a 10-14 day rest period a retest/challenge dose was applied once to a previously unexposed test site. Test sites were evaluated by trained laboratory personnel 48 and 96 hours after application.

 

RESULT: No adverse reactions of any kind were reported during the course of this study.

 

CONCLUSION: Under the conditions of the study, there was no indication of a potential to elicit dermal irritation or sensitization (contact allergy) noted for Olaplex Bond Builder No. 1 (BisaminopropyIDiecoIDimaIeate 20%)