1,3-Propanediaminium, 2-hydroxy-N1,N3-bis(2-hydroxyethyl)-N1,N1,N3,N3-tetramethyl-, chloride (1:2)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The most standardised method used today, to establish the sensitizing potency of chemicals, is the local lymph node assay (LLNA). Historically the Human Repeated Insult Patch Test (HRIPT), a test conducted in healthy controls, has been widely used, particularly in the US. As the end-point is prevention of human disease, human data, if available, have a particular importance and impact for the final decisions. The test numbers were restricted in this case to nine individuals, which is probably not sufficient for the test to be truly representative hence the reliability score of 2 rather than 1.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Human Repeated Insult Patch Test (HRIPT)

Deviations:

not specified

Principles of method if other than guideline:

The upper arm served as the treatment area. Approximately 0.5 ml of the test material was applied to the 1” X 1/2” absorbent pad portion of an adhesive dressing. This was then applied to the treatment site to form a semi-occlusive patch.
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. Participants were instructed to remove all patches 24 hours after application. If any site exhibited a moderate (2-level) reaction during the induction phase, application was moved to an adjacent area.
Rest periods consisted of twenty-four hours following each Tuesday and Thursday removal, and forty-eight hours following each Saturday removal.
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 was evaluated twenty-four and seventy-two hours after application.

GLP compliance:

no

Type of study:

patch test

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxy-N,N'-bis(2-hydroxyethyl)-N,N,N',N'-tetramethylpropane-1,3-diaminium dichloride

EC Number:

807-137-2

Cas Number:

110528-94-4

Molecular formula:

2-hydroxy-N,N'-bis(2-hydroxyethyl)-N,N,N',N'-tetramethylpropane-1,3-diaminium dichloride

IUPAC Name:

2-hydroxy-N,N'-bis(2-hydroxyethyl)-N,N,N',N'-tetramethylpropane-1,3-diaminium dichloride

Test material form:

other: aqueous solution

Details on test material:

Cola®Moist 200, lot # 21035J08, was diluted to 10% activity with deionized water.

In vivo test system

Test animals

Species:

human

Sex:

male/female

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

10% active material

Challenge

Concentration / amount:

10% active material

No. of animals per dose:

Nine persons took part in the testing

Details on study design:

Use repetitive epidermal contact to determine the potential of the title compound to induce primary or cumulative irritation and/or allergic contact
sensitization.

Challenge controls:

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 was evaluated twenty-four and seventy-two hours after application.

Positive control substance(s):

not required

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

Approximately 0.5 ml of the 10% active test material was applied to the 1” X 1/2” absorbent pad portion of an adhesive dressing. This was then applied to the treatment site to form a semi-occlusive patch.

No. with + reactions:

0

Total no. in group:

9

Clinical observations:

none

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Approximately 0.5 ml of the 10% active test material was applied to the 1” X 1/2” absorbent pad portion of an adhesive dressing. This was then applied to the treatment site to form a semi-occlusive patch.. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

~0.5ml of 10% active material

No. with + reactions:

0

Total no. in group:

9

Clinical observations:

none

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: ~0.5ml of 10% active material. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none.

Results 3

Reading:

other: 9th reading

Hours after challenge:

216

Group:

test chemical

Dose level:

~0.5ml of 10% active material

No. with + reactions:

1

Total no. in group:

9

Clinical observations:

Barely perceptible or spotty erythema

Remarks on result:

other: Reading: other: 9th reading. . Hours after challenge: 216.0. Group: test group. Dose level: ~0.5ml of 10% active material. No with. + reactions: 1.0. Total no. in groups: 9.0. Clinical observations: Barely perceptible or spotty erythema.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Under the conditions of this study, test material Cola®Moist 200, lot # 21035J08, did not indicate a potential for dermal irritation or allergic contact sensitization.