3-{3-[(3,5,5-trimethylhexanoyl)oxy]-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propoxy}-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propyl 3,5,5-trimethylhexanoate

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

08 Mar - 10 Mar 2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable study which meets basic scientific principles

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Type of study / information:

Skin irritating potential in humans

Endpoint addressed:

skin irritation / corrosion

Principles of method if other than guideline:

The test substance was dermally applied as supplied under occlusive conditions for 24 h, on the upper back of 12 volunteers and the reaction of the skin was observed about 30 min to 1 h and 24 h after patch removal.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

84418-63-3

Cas Number:

84418-63-3

IUPAC Name:

84418-63-3

Details on test material:

- Name of test material (as cited in study report): pentaisononanoate de dipentaerythritol- Analytical purity: no data- Lot/batch No.: 05028310

Method

Ethical approval:

confirmed, but no further information available

Details on study design:

Subjects:- Number of subjects exposed: 12- Sex: male and female- Age: 22-65TYPE OF TEST(S) USED: patch test (epicutaneous test)ADMINISTRATION- Type of application: occlusive- Concentrations: applied pure- Volume applied: 20μL- Testing schedule: Occlusive patches of test substance for 24 h with cutaneous examination 30 min after removal.EXAMINATIONS- Grading/Scoring system: according to the following scheme:Erythema0 = none1 = doubtful pinkness of all the site or clearly visible pinkness of only a part of the site2 = clear pinkness of all the site or redness of only a part of the site3 = clear redness of all the site or intensive redness of only a part of the site 4 = intensive redness ans / or burn aspectEdema0 = none1 = doubtful swelling of all the site or slight swelling of only a part of the site2 = slight swelling of all the site or clear swelling of only a part of the site3 = clear swelling of all the site or strong swelling of only a part of the site 4 = strong swelling of all the site, even extending beyond the siteVesicles0 = none1 = few small vesicles (< 1 mm Ø), on less than 1/4 of the site2 = small vesicles (< 1 mm Ø), on about 1/4 of the site3 = small vesicles (< 1 mm Ø), on 1/4 - 1/2 of the site or one large vesicle (1 - 2 mm Ø)4 = some small vesicles (< 1 mm Ø), on more than 1/2 of the site or some large vesicle (1 - 2 mm Ø)Cutaneous dryness0 = none1 = dullness, matness of all the site or powdery aspect of only a part of the site2 = powdery aspect of all the site or some scaling/flaking of only a part of the site3 = scaling/flaking of of all the site or thick scales/flakes on only a part of the site4 = some thick scales/flakes on all the site with possibly deep crackingWrinkling0 = none1 = slight wrinkling of all the site or clear wrinkling of only a part of the site2 = distinct wrinkling of all the site or well-developed wrinkling of only a part of the site3 = well-developed wrinkling into ridges and troughs of all the site or severe wrinkling of only a part of the site 4 = wrinkling forms deep troughs and high ridgesGlazing0 = none1 = all site slightly shiny or only a part of the site clearly shiny2 = all site clearly shiny or glossiness of only a part of the site3 = clear glossiness of all the site or very glossy aspect of only a part of the site4 = all site very glossy and / or highly reflective

Details on exposure:

Patch test with volunteers, general population

Results and discussion

Results:

No skin reaction was observed in any of the subjects. Primary skin irritation index = 0.0

Any other information on results incl. tables

Table 1: Results - individual irritation scores

Reading 1 (30 min)	Erythema		Edema		Vesicles		Wrinkling		Glazing		Dryness
	P	TS	P	TS	P	TS	P	TS	P	TS	P	TS
1	2.5	0	0	0	0	0	1	0	0	0	0	0
2	2	0	0	0	0	0	0	0	0	0	0	0
3	3	0	0	0	0	0	0	0	0	0	0	0
4	3	0	1	0	0	0	0	0	0	0	0	0
5	2.5	0	0.5	0	0	0	0	0	0	0	0	0
6	2	0	0	0	0	0	0	0	0	0	0	0
7	2.5	0	2	0	0	0	0.5	0	0	0	0	0
8	0.5	0	0	0	0	0	0	0	0	0	0	0
9	2.5	0	1	0	0	0	0	0	0	0	0	0
10	2	0	1.5	0	0	0	0	0	0	0	0	0
11	2	0	1	0	0	0	0	0	0	0	0	0
12	2.5	0	1	0	0	0	0	0	0	0	0	0
Reading 2 (24 h)	Erythema		Edema		Vesicles		Wrinkling		Glazing		Dryness
	P	TS	P	TS	P	TS	P	TS	P	TS	P	TS
1	2.5	0	0	0	0	0	0	0	0	0	0	0
2	1.5	0	0	0	0	0	0	0	0	0	0	0
3	2.5	0	0	0	0	0	0	0	0	0	0	0
4	2.5	0	2	0	0	0	1	0	0	0	0	0
5	2	0	1	0	0	0	1	0	0	0	0	0
6	1	0	0	0	0	0	0	0	0	0	0	0
7	2.5	0	1	0	0	0	0	0	0	0	0	0
8	1.5	0	0.5	0	0	0	1	0	0	0	0	0
9	1	0	0.5	0	0	0	0	0	0	0	0	0
10	2	0	0	0	0	0	0	0	0	0	0	0
11	1.5	0	0	0	0	0	0	0	0	0	0	0
12	1	0	0	0	0	0	0	0	0	0	0	0

P: Positive Control

TS: Test Substance

Applicant's summary and conclusion

Conclusions:

Not irritating