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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: An adaptation of the repeated insult patch test procedure suggested by Draize (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, published 1959 by The Association of Food and Drug Officials of the United States, p.52).
GLP compliance:
no
Remarks:
Study predates GLP.
Type of study:
patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SC-1167V
- Physical state: clear, odorous liquid

In vivo test system

Test animals

Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
- Type of population: general
- Number of subjects exposed: 43 subjects, of whom 38 completed the program
- Age: 16 to >60

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Challenge
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)

Results and discussion

Any other information on results incl. tables

The individual reaction scores and group totals for each scoring are as follows. The columns A and A' designate first and second scorings of the challenge.

Subject

Applications

1

2

3

4

5

6

7

8

9

A

A’

1

0

0

0

0

-

*0

0

0

0

0

0

2

0

0

0

0

0

0

0

0

0

0

0

3

0

0

0

0

0

0

0

0

0

0

0

4

0

0

0

0

0

0

0

0

0

-

0

5

0

0

0

0

-

*0

0

0

0

0

0

6

0

0

0

0

0

0

0

0

0

0

0

7

0

0

0

0

0

0

0

0

0

0

-

8

0

0

0

0

0

0

0

0

0

0

-

9

0

0

0

0

0

0

0

0

0

0

0

10

0

0

0

0

0

0

0

0

0

0

0

11

0

0

0

0

0

0

0

0

0

0

0

12

0

0

0

0

0

0

0

0

0

0

0

13

0

0

0

0

0

-

*0

0

0

0

0

14

0

0

0

0

0

0

0

0

0

0

0

15

0

0

0

0

0

0

0

0

0

0

0

16

0

0

0

0

0

0

0

0

0

0

0

17

0

0

0

0

0

0

0

0

0

0

0

18

Dropped

19

0

0

0

0

0

0

0

0

0

0

0

20

0

0

0

0

0

0

0

0

0

0

-

21

0

0

0

0

0

0

0

0

0

0

0

22

0

0

0

0

0

0

0

0

0

0

0

23

0

0

0

0

0

0

0

0

0

0

0

24

0

0

0

0

0

0

0

0

0

0

0

25

0

0

0

0

0

0

0

0

0

0

0

26

0

-

*0

0

0

Dropped

27

0

0

0

0

0

0

0

0

-

0

0

28

0

0

0

0

0

0

0

0

-

0

0

29

0

0

0

0

0

0

0

0

-

0

0

30

0

0

Dropped

31

-

*0

0

0

0

0

0

0

0

0

0

32

0

-

*0

0

0

0

0

0

0

0

0

33

0

0

0

0

0

0

0

0

-

0

0

34

0

0

0

0

0

0

0

0

-

0

0

35

0

0

0

0

0

0

0

0

0

0

0

36

0

0

0

R0

R0

R0

R0

R0

-

0

0

37

Dropped

38

0

0

0

0

0

0

0

0

-

0

0

39

0

0

0

0

0

0

0

0

-

0

0

40

0

0

0

0

0

0

0

0

-

0

0

41

0

0

0

0

0

0

0

0

-

0

0

42

0

0

0

0

0

0

0

0

-

0

0

43

0

0

0

Dropped

 

Totals

0

40

38

38

39

37

35

37

38

26

37

35

NP

1

3

2

0

2

3

1

0

12

1

3

 -= Subject absent

*= Residual reaction to earlier application, after absence, not included in the score totals.

R= Applied to second site because of tape reaction or for other reason irrelevant to test.

NP= Number of subjects no included in score totals (-, *)

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The irrative properties of the test substance on human skin and whether it tends to cause sensitization reactions was determined according to an adaptation of the insult patch test procedure suggested by Draize (1959). Under the conditions of this study the test substance caused no primary irritation. None of the 38 subjects tested were sensitised by the sample of the test substance.