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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is limitedly reported, but the method is similar to EPA OPPTS 870.2600 (Draize test).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
equivalent or similar to
Guideline:
other:
Principles of method if other than guideline:
EPA OPPTS 870.2600 (Skin Sensitization); Human Repeated Insult Patch Tests (HRIPT). The procedure used was an adaptation of the method of Draize. Semi-occlusive, 8-9 applications of 24-Hr each
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Galaxolide 50- Lot/batch No.: sc 04-0845

Method

Route of administration:
dermal

Results and discussion

Results of examinations:
no primary irritation and no sensitisation

Any other information on results incl. tables

Remarks on results including tables and figures

Table 2 allergies, dermatitides and concomitant medication for all panelists receiving applications of group 118 samples

Panelist No.

Allergies

Dermatitides

Concomitant Medication

1

None

None

None

2

Chocolate

None

None

3

None

None

None

4

None

None

None

5

Penicillin

None

Blood Thinner

6

None

None

None

7

None

None

None

8

None

None

None

9

None

None

None"

10

None

None

None

11

None

None

None

12

None

Eczema

None

13

None

None

Valium II

14

None

None

None

15

Most medicines

None

None

16

None

None

None

17

None

None

None

18

None

None

None

19

None

None

None

20

None

None

None

21

Dropped

22

None

None

Thyroid and Decongestant

23

Dropped

24

Pollen

None

None

25

None

None

"None

26

None

Slight acne

None

27

None

None

None

28

None

None

None

29

None

None

None

30

None

None

None

31

Pollens, some perfumes

None

Nerve medicine

32

None

None

None

33

None

None

None

34

None

None

None

35

None

None

None

36

None

None

None

37

None

None

None

38

Hay fever

None

None

39

None

None

None

40

None

None

None

41

Hay fever

None

None

42

None

None

None

43

None

None

None

44

None

None

None

45

None

None

None

Applicant's summary and conclusion

Conclusions:
HHCB and the solvent control resulted in little or no primary irritation and no sensitisation
Executive summary:

In a HRIPT test, 43 subjects (group 118) were tested with a 50 % solution of Galaxolide 50in ethanol by application of 0.5 ml of the solution on test patches (1x1 inch Webril swatch affixed to the centre of a 1x2 inch elastic bandage) to the upper arms for 24 hrs 3 time/week for 3 weeks (9 applications) to the same site if possible. Approximately 2 weeks after removal of the final patch, challenge duplicate patches were applied, one to the original site, one to a fresh skin site. Scores were recorded at 48 or 72 hours after application of the patches. HHCB and the solvent control resulted in little or no primary irritation and no sensitisation