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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
Qualifier:
according to
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
Species:
human
Sex:
male/female
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
10% active material
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
Reading:
1st reading
Hours after challenge:
24
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
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.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
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.
Reading:
other: 9th reading
Hours after challenge:
216
Group:
test group
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Similar tests carried out on a larger sample of humans (200) using a solution of a read-across substance (choline chloride) also suggested that there was no sensitisation effect from this type of substance.


Migrated from Short description of key information:
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.

Justification for selection of skin sensitisation endpoint:
Key study conducted on humans usng the HRIPT test method and a 70% active solution of the ColaMoist 200 material

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification