2-ethylhexyl 3,5,5-trimethylhexanoate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation, other

Remarks:

Conducted on Humans

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2005-06-06 to 2005-07-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Repeated insult patch test on humans, protocol No. 1.01

Principles of method if other than guideline:

This study has been performed with adherence to the applicable ICH guideline E6 for Good Clinical Practice and requirements provided for in 21 CFR part 50 and 56 and in accordance with standard operating procedures and applicable protocols.

GLP compliance:

no

Type of study:

patch test

Justification for non-LLNA method:

The study was conducted on human subjects, as per annex VII 8.3.1 Column 2: an LLNA test does not need to be conducted because In vivo skin sensitisation studies were carried out or initiated before 11 October 2016, and they meet the requirements set out in Article 13(3), first subparagraph, and Article 13(4).

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl 3,5,5-trimethylhexanoate

EC Number:

275-073-7

EC Name:

2-ethylhexyl 3,5,5-trimethylhexanoate

Cas Number:

70969-70-9

Molecular formula:

C17H34O2

IUPAC Name:

2-ethylhexyl 3,5,5-trimethylhexanoate

In vivo test system

Test animals

Species:

human

Sex:

male/female

Details on test animals and environmental conditions:

Fifty-nine qualifed subjects (15 male and 44 female) ranging in age from 16 to 79 years, were selected for this evaluation. Fifty-two subjects completed this study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material. No controls (postive or challenge) were used.

Only one dose (undiluted) was applied.

The treatment area was defined as the epicutaneous area of the upperback between the scapulae. 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 then applied to the appropropriate treatment site to form a semi-occlusive patch.

Results and discussion

Positive control results:

No controls used

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

undiluted

No. with + reactions:

0

Total no. in group:

52

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 52.0. Clinical observations: none.

Results 2

Key result

Reading:

2nd reading

Hours after challenge:

72

Group:

test chemical

Dose level:

undiluted

No. with + reactions:

0

Total no. in group:

52

Clinical observations:

none

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 52.0. Clinical observations: none.

Any other information on results incl. tables

The following Evaluation Key was used during induction and challenge phase:

0 = No visible skin reaction

+ = Barely perceptible or spotty erythema

1 = Mild erythema covering most of the test site

2 = Moderate erythema, possible presence of mild edema

3 = Marked erythema, possible edema

4 = Severe erythema, possible edema, vesiculation, bullae and/or ulceration

During induction phase only one subject showed a moderate erythema, which fully reversed till the second induction. one other subject showed a mild erythema at the first induction reading which revered till the next reading. Thus the substance also did not show any significant skin irritation.

During first and second challenge, no positive reactions were obversed in any of the volunteers (all scores 0).

The study authors concluded that under the conditions of this study, test material Body Oil RP113 -44, did not indicate a potential for dermal iriitation or allergic contact sensitization.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

2-ethylhexyl 3,5,5-trimethylhexanoate is not sensitising to skin as shown on 52 human volunteers.

Executive summary:

59 volunteers (of which 52 concluded the test) were exposed semi-occlusive to undiluted test material in total 10 times in the induction phase. No significant skin irritation was obeserved throughout this induction phase. Two weeks following the induction phase, volunteers were exposed semi-occlusively again to the undiluted test material (challenge phase) and none of them did show any positive reaction. The study authors concluded that under the conditions of this study, test material Body Oil RP113 -44, did not indicate a potential for dermal iriitation or allergic contact sensitization.