Butanedioic acid, 2-hydroxy-, 1,4-bis[5,7,7-trimethyl-2-(1,3,3-trimethylbutyl)octyl] ester

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 14 - October 22, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Protocol No.: CP-01.0lS

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate

EC Number:

807-422-1

Cas Number:

66918-01-2

Molecular formula:

C40H78O5

IUPAC Name:

1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate

Details on test material:

- Name of test material (as cited in study report): SALACOS 222
- Physical state: liquid
- Analytical purity: > 98%
- Lot/batch No.: 7-2-D
- Expiration date of the lot/batch: 04/10
- Stability under test conditions: stable
- Storage condition of test material: room temperature (20 +/- 5 °C)

Specific details on test material used for the study:

Lot#: 5-4-C

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

Fifty-six (56) qualified subjects, male and female, ranging in age from 18 to
79 years, were selected for this evaluation. All fifty-six (56) subjects
completed this study.

Clinical history:

Medical history is recorded before inclusion to study

exclusion criteria: a. Ill health.
b. Under a doctor's care or taking medication(s) which could influence the
outcome of the study.
c. Females who are pregnant or nursing.
d. A history of adverse reactions to cosmetics or other personal care
products.

Controls:

none

Route of administration:

dermal

Details on study design:

The upper back between the scapulae served as the treatment area.
Approximately 0.2 g 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 appropriate treatment site to
form a semi-occlusive patch.
Induction Phase:
Patches were applied three (3) times per week (e.g., Monday, Wednesday,
and Friday) for a total of nine (9) applications. The site was marked to ensure
the continuity of patch application. 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.
The evaluation of this site was made again just prior to re-application. If a
participant was unable to report for an assigned test day, one (1) makeup day
was permitted. This day was added to the Induction period.
With the exception of the first supervised Induction Patch reading, if any test
site exhibited a moderate (2-level) reaction during the Induction Phase,
application was moved to an adjacent area. Applications were discontinued
for the remainder of this test phase, if a moderate (2-level) reaction was
observed on this new test site. Applications would also be discontinued if
marked (3-level) or severe ( 4-level) reactivity was noted.
Rest periods consisted of one day following each Tuesday and Thursday
removal, and two days following each Saturday removal.
Challenge Phase:
Approximately two (2) 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 scored at the clinic Day 1 and Day 3
post-application.
Evaluation Criteria (Erythema and additional Dermal Seguelae):
0 = No visible skin reaction
0.5 Barely perceptible
1 = Mild
2 = Moderate
3 = Marked
4 = Severe
E = Edema
D = Dryness
S = Staining
P = Papules
V = Vesicles
B = Bullae
U = Ulceration
Sp = Spreading
Erythema was scored numerically according to this key. If present, additional
Dermal Sequelae were indicated by the appropriate letter code and a
numerical value for severity.

Results and discussion

Results of examinations:

The results of each participant are appended (Table 1 ).
Observations remained negative throughout the test interval.

Any other information on results incl. tables

Subject Number	Day 1*	Induction Phase									Virgin Challenge Site
		1	2	3	4	5	6	7	8	9	Day 1*	Day 3
1	0	0	0	0	0	0	0	0	0	0	0	0
2	0	0	0	0	0	0	0	0	0	0	0	0
3	0	0	0	0	0	0	0	0	0	0	0	0
4	0	0	0	0	0	0	0	0	0	0	0	0
5	0	0	0	0	0	0	0	0	0	0	0	0
6	0	0	0	0	0	0	0	0	0	0	0	0
7	0	0	0	0	0	0	0	0	0	0	0	0
8	0	0	0	0	0	0	0	0	0	0	0	0
9	0	0	0	0	0	0	0	0	0	0	0	0
10	0	0	0	0	0	0	0	0	0	0	0	0
11	0	0	0	0	0	0	0	0	0	0	0	0
12	0	0	0	0	0	0	0	0	0	0	0	0
13	0	0	0	0	0	0	0	0	0	0	0	0
14	0	0	0	0	0	0	0	0	0	0	0	0
15	0	0	0	0	0	0	0	0	0	0	0	0
16	0	0	0	0	0	0	0	0	0	0	0	0
17	0	0	0	0	0	0	0	0	0	0	0	0
18	0	0	0	0	0	0	0	0	0	0	0	0
19	0	0	0	0	0	0	0	0	0	0	0	0
20	0	0	0	0	0	0	0	0	0	0	0	0
21	0	0	0	0	0	0	0	0	0	0	0	0
22	0	0	0	0	0	0	0	0	0	0	0	0
23	0	0	0	0	0	0	0	0	0	0	0	0
24	0	0	0	0	0	0	0	0	0	0	0	0
25	0	0	0	0	0	0	0	0	0	0	0	0
26	0	0	0	0	0	0	0	0	0	0	0	0
27	0	0	0	0	0	0	0	0	0	0	0	0
28	0	0	0	0	0	0	0	0	0	0	0	0
29	0	0	0	0	0	0	0	0	0	0	0	0
30	0	0	0	0	0	0	0	0	0	0	0	0
31	0	0	0	0	0	0	0	0	0	0	0	0
32	0	0	0	0	0	0	0	0	0	0	0	0
33	0	0	0	0	0	0	0	0	0	0	0	0
34	0	0	0	0	0	0	0	0	0	0	0	0
35	0	0	0	0	0	0	0	0	0	0	0	0
36	0	0	0	0	0	0	0	0	0	0	0	0
37	0	0	0	0	0	0	0	0	0	0	0	0
38	0	0	0	0	0	0	0	0	0	0	0	0
39	0	0	0	0	0	0	0	0	0	0	0	0
40	0	0	0	0	0	0	0	0	0	0	0	0
41	0	0	0	0	0	0	0	0	0	0	0	0
42	0	0	0	0	0	0	0	0	0	0	0	0
43	0	0	0	0	0	0	0	0	0	0	0	0
44	0	0	0	0	0	0	0	0	0	0	0	0
45	0	0	0	0	0	0	0	0	0	0	0	0
46	0	0	0	0	0	0	0	0	0	0	0	0
47	0	0	0	0	0	0	0	0	0	0	0	0
48	0	0	0	0	0	0	0	0	0	0	0	0
49	0	0	0	0	0	0	0	0	0	0	0	0
50	0	0	0	0	0	0	0	0	0	0	0	0
51	0	0	0	0	0	0	0	0	0	0	0	0
52	0	0	0	0	0	0	0	0	0	0	0	0
53	0	0	0	0	0	0	0	0	0	0	0	0
54	0	0	0	0	0	0	0	0	0	0	0	0
55	0	0	0	0	0	0	0	0	0	0	0	0
56	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, test material, Cosmol 222, Lot#: 5-4-C,
indicated no potential for dermal irritation or allergic contact sensitization.