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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
Study period:
12 September 2007 to 18 October 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Principles of method if other than guideline:
Repeated Insult Patch Test Protocol No. : 1.01 (Consumer Product Testing Co.)

Although not stated, the procedure used was essentially that of Draize (Procedures for the appraisal of the toxicity of chemicals in foods, drugs, and cosmetics. VIII. Dermal toxicity, Food Drug Cosmetic Law J. 10:722-731, 1955).
GLP compliance:
yes (incl. QA statement)
Type of study:
patch test
Species:
human
Strain:
other: not applicable
Sex:
male/female
Details on test animals and environmental conditions:
Participants:

Fifty-six (56) male and female subjects ranging in age from 16 to 76 years. Fifty (50) subjects completed the study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material.

Inclusion Criteria:

The following criteria applied to study participants: male and female, age 16 or older; an absence of any visible skin disease which might confuse the study results; prohibition on the use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation; completion of medical history forms and informed consent forms; considered reliable and capable of following directions.

Exclusion Criteria:

The following applied: ill health; someone under a doctor's care and taking medication that might influence the outcome of the study; pregnant or nursing females; a history of adverse reactions to cosmetics or other personal care products.
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
20%
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
20%
No. of animals per dose:
50 participants completed the study
Details on study design:
Test Material Preparation:

The test material was prepared as a 20% dilution in corn oil.

Application Area:

The upper back between the scapulae served as the treatment area. Approximately 0.2 ml of the test material, or an amount sufficient to cover the contact surface, was applied to a 3/4 inch x 3/4 inch absorbent pad portion of an adhesive bandage. This was then applied to the appropriate treatment site to form an occlusive patch.

Induction Phase:

Patches were applied 3 times weekly (e.g., Monday, Wednesday and Friday) for a total of 9 applications. The site was marked to ensure the continuity of patch applications. Following supervised removal and scoring of the first induction patch, participants were instructed to remove all subsequent induction patches at home, twenty-four hours after application. Site evaluations were performed prior to re-application.

Challenge Phase:

Approximately 2 weeks after induction patch applications, a challenge patch was applied to a virgin (untreated) site adjacent to the original induction patch site, following the same procedure for Induction. The challenge patches were removed and the sites scored at the clinic 24 and 72 hours after applications.
Challenge controls:
None
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
50
Clinical observations:
No positive reactions for irritation or allergic contact sensitization.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 50.0. Clinical observations: No positive reactions for irritation or allergic contact sensitization..
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
50
Clinical observations:
No positive reactions for irritation or allergic contact sensitization.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 50.0. Clinical observations: No positive reactions for irritation or allergic contact sensitization..
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, test material RX14180 Lot# ABP4-071907 did not indicate a potential for dermal irritation or allergic contact sensitization.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The subject chemical was negative when tested in 56 human volunteers in a HRIPT. The surrogate substance, undecenyl methoxycrylene, was not considered a skin sensitizer when tested in the mouse LLNA.


Migrated from Short description of key information:
The surrogate chemical, undecenyl methoxycrylene, was negative when tested in vivo in an OECD Guideline 429 study (Skin Sensitisation: Local Lymph Node Assay). There was also a study done on human data on the actual test material EHMC, involving 56 humans, which also showed that the substance showed no signs of causing skin sensitisation.

Justification for selection of skin sensitisation endpoint:
There are two studies which provide data for skin sensitisation, one study has been conducted according to OECD guidelines on a read across material UMC. We have assigned a klimisch scale reliability of 2 to this GLP and OECD guideline study as the study is being used for read across.

There is a second study which has been conducted on the actual test substance (EHMC), this study used 56 humans, both studies produced negative results and have been classed as a reliability of 2 on the klimisch scale. We have used the study on human data on EHMC as the key study as this study contains data on the actual substance.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No study data available


Migrated from Short description of key information:
No study data available

Justification for classification or non-classification

From the data from the key study (Undecenyl methoxycrylene: LOCAL LYMPH NODE ASSAY IN THE MOUSE ), a Stimulation Index of 0.72 was achieved. A positive reaction is identified if the Stimulation Index equals >=3. Therefore it can be concluded that EHMC is not a sensitizer.