Fatty acids, C18 (saturated and unsaturated) ethyl esters

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012.10.10-2012.21.11

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Repeated insult patch test (human) carried out according to ICH Guideline E6 for Good Clinical Practice. Testmaterial is stated to be Bioester XP 3511 form the registrant but no further ID of the test substance included in the testing report. Registrant state that Bioester XP 3511 is Fatty acids, C18 (saturated and unsaturated) ethyl ester).

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

Repeated insult patch test (human) carried out according to ICH Guideline E6 for Good Clinical Practice. The human skin sensitization test was carried out to evaluate the potential of the test subsnatce (Bioester XP 3511) to induce primary or cumulative irritation and/or allergic contact sensitization by repetative
dermal contact using an induction and challenge phase.

GLP compliance:

yes

Remarks:

Study performed in accordance to GCP

Type of study:

other: Repeated insult patch test (human)

Species:

human

Strain:

other: Not applicable

Sex:

male/female

Details on test animals and environmental conditions:

Fifty-seven qualified human subjects (male and female) ranging in age from 19 to 78 years, were elected for the evaluation. Fifty subjects completed the study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application to the test material. Subjects not fitted for the study (subjects with skin diseases, medical history etc.) were not included in the study.

Route:

epicutaneous, semiocclusive

Vehicle:

no data

Concentration / amount:

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 the 1" x 1" absorbent pad portion of a clear adhesive dressing. This was apllied to the appropriate treatment site to form a semi-occlusive patch.

Route:

intradermal

Vehicle:

no data

Concentration / amount:

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 the 1" x 1" absorbent pad portion of a clear adhesive dressing. This was apllied to the appropriate treatment site to form a semi-occlusive patch.

No. of animals per dose:

NA

Details on study design:

NA

Challenge controls:

NA

Positive control substance(s):

no

Positive control results:

NA

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.2 ml

No. with + reactions:

0

Total no. in group:

57

Clinical observations:

No effects observed

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 ml. No with. + reactions: 0.0. Total no. in groups: 57.0. Clinical observations: No effects observed.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.2 ml

No. with + reactions:

0

Total no. in group:

57

Clinical observations:

No effects observed

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 ml. No with. + reactions: 0.0. Total no. in groups: 57.0. Clinical observations: No effects observed.

No adverse effects observed.

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, Bioester XP 3511 (Fatty acids, C18 (saturated and unsaturated) ethyl ester), did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization.

Executive summary:

A human patch repeated insult patch test (HRIPT) was performed with Bioester XP 3511 (test substance) in accordance with ICH Guideline E6 for Good Clinical Practice. 57 subjects were included in the study using an inducting and challenge phase.

Patches with 0.2 ml were applied three times per week for a total of nine applications (induction phase) and reading were performed.

Approximately two weeks after the final induction patch application, a challenge pathc was applied to a virgin site adjecent to the originalinduction patch site, following the same procedure described for induction. The patch was removed and the site scored at the clinic twenty-four and seventy-two post-application.

Under the conditions of this study, test material, Bioester XP 3511 (Fatty acids, C18 (saturated and unsaturated) ethyl ester) , did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization. Thus, Bioester XP 3511 was concluded to be a non-sensitizer.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

A human patch repeated insult patch test (HRIPT) was performed with Bioester XP 3511 (test substance) in accordance with ICH Guideline E6 for Good Clinical Practice. 57 subjects were included in the study using an inducting and challenge phase. Patches with 0.2 ml were applied three times per week for a total of nine applications (induction phase) and reading were performed after the 24 hour exposure period. Approximately two weeks after the final induction patch application, a challenge pathc was applied to a virgin site adjecent to the originalinduction patch site, following the same procedure described for induction. The patch was removed and the site scored at the clinic twenty-four and seventy-two hours post-application.

No effects were seen. Thus, Bioester XP 3511 (fatty acids, C18 (saturated and unsaturated) ethyl ester) was concluded to be a non-sensitizer.

It is noted that data from an LLNA study is not available. Based on the toxicokinetic properties and available human data, further in vivo testing for skin sensitization was evaluated to be scientifically unjustified.

Migrated from Short description of key information:

Under the conditions of this study, test material, Bioester XP 3511 (Fatty acids, C18 (saturated and unsaturated) ethyl ester) , did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization. Thus, Bioester XP 3511 was concluded to be a non-sensitizer.

Justification for selection of skin sensitisation endpoint:

Repeated insult patch test (human) carried out according to ICH Guideline E6 for Good Clinical Practice.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

NA

Migrated from Short description of key information:

NA

Justification for selection of respiratory sensitisation endpoint:

NA

Justification for classification or non-classification

Based on the available human data (HRIPT) from which it was shown that Bioester XP 3511 (Fatty acids, C18 (saturated and unsaturated) ethyl ester) did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization, no classification should apply according to the Skin Sens. criteria.