Registration Dossier

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Currently viewing:

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
10th December to 15th December 1984
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted in 1984 and is not described as having been conducted to any recognised guideline. The method is explained in very brief detail within the report and lacks important information such as the demographics and the medical history of the volunteers which is critical to the validity of the results. Neither the batch details nor the purity of the substance are reported and the test is described as being conducted using a preparation of the substance (present at only 5%) in Vaseline. Concurrent vehicle controls were run during the study. The results are presented in table form with simple “positive/negative” descriptions of any reaction without being qualified. As the substance was not tested up to a concentration approaching full strength, it cannot be considered as reliable for assessing the irritancy potential of the substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A human patch test was performed to assess the irritation potential of the test material. An application of the test material at 5 % in vaseline was applied to the upper arm of human volunteers.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3-[[5-methyl-2-(1-methylethyl)cyclohexyl]oxy]propane-1,2-diol
EC Number:
289-296-2
EC Name:
3-[[5-methyl-2-(1-methylethyl)cyclohexyl]oxy]propane-1,2-diol
Cas Number:
87061-04-9
Molecular formula:
C13H26O3
IUPAC Name:
3-[[5-methyl-2-(1-methylethyl)cyclohexyl]oxy]propane-1,2-diol
Test material form:
liquid

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 25
- Sex: 16 males and 9 females
- Age: Aged between 22 and 61
Ethical approval:
not specified
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
A 5 % sample of the test material was prepared in Vaseline on a Toril test plaster. The test plasters were applied to the upper arms of the volunteers as an occluded patch for 48 hours. A control consisting of Vaseline alone was used.
Examinations:
- Irritation: Readings were performed at one hour and twenty four hours after removal of the patch.

Results and discussion

Results of examinations:
- Irritation: No positive reactions were observed.

Any other information on results incl. tables

Table 1: Results

 

Volunteer Number

Sex

Age

Vaseline Control

5 % Test Material

24 Hours

48 Hours

1

M

33

-

-

-

2

M

34

-

-

-

3

F

25

-

-

-

4

F

22

-

-

-

5

M

38

-

-

-

6

M

37

-

-

-

7

M

22

-

-

-

8

M

36

-

-

-

9

M

37

-

-

-

10

M

32

-

-

-

11

F

22

-

-

-

12

M

42

-

-

-

13

M

27

-

-

-

14

M

24

-

-

-

15

M

23

-

-

-

16

M

26

-

-

-

17

M

38

-

-

-

18

M

35

19

F

22

-

-

-

20

F

28

-

-

-

21

F

40

-

-

-

22

F

19

-

-

-

23

M

47

-

-

-

24

F

61

-

-

-

25

F

23

-

-

-

 

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study, no irritation was observed in human volunteers.
Executive summary:

A human patch test was performed on 25 volunteers using a 5 % preparation (in Vaseline) of the test material. The subjects were exposed to the test material for 48 hours using an occluded patch. None of the volunteers of the study exhibited a positive reaction to the test material.

Categories Display