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Toxicological information

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

Reference
Name:
Unnamed
Type:
Constituent
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: 22-65

TYPE 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:

Erythema
0 = none
1 = doubtful pinkness of all the site or clearly visible pinkness of only a part of the site
2 = clear pinkness of all the site or redness of only a part of the site
3 = clear redness of all the site or intensive redness of only a part of the site
4 = intensive redness ans / or burn aspect

Edema
0 = none
1 = doubtful swelling of all the site or slight swelling of only a part of the site
2 = slight swelling of all the site or clear swelling of only a part of the site
3 = 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 site

Vesicles
0 = none
1 = few small vesicles (< 1 mm Ø), on less than 1/4 of the site
2 = small vesicles (< 1 mm Ø), on about 1/4 of the site
3 = 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 dryness
0 = none
1 = dullness, matness of all the site or powdery aspect of only a part of the site
2 = powdery aspect of all the site or some scaling/flaking of only a part of the site
3 = scaling/flaking of of all the site or thick scales/flakes on only a part of the site
4 = some thick scales/flakes on all the site with possibly deep cracking

Wrinkling
0 = none
1 = slight wrinkling of all the site or clear wrinkling of only a part of the site
2 = distinct wrinkling of all the site or well-developed wrinkling of only a part of the site
3 = 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 ridges

Glazing
0 = none
1 = all site slightly shiny or only a part of the site clearly shiny
2 = all site clearly shiny or glossiness of only a part of the site
3 = clear glossiness of all the site or very glossy aspect of only a part of the site
4 = 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