3,6,9-trioxaundecane-1,11-diol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Prior to or in 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Principles of method if other than guideline:

Sensitization study with human volunteers

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

Sensitization study with human volunteers

Test material

Test material information

Constituent 1

Reference substance name:

3,6,9-trioxaundecane-1,11-diol

EC Number:

203-989-9

EC Name:

3,6,9-trioxaundecane-1,11-diol

Cas Number:

112-60-7

Molecular formula:

C8H18O5

IUPAC Name:

2-{2-[2-(2-hydroxyethoxy)ethoxy]ethoxy}ethan-1-ol

Specific details on test material used for the study:

clear liquid

In vivo test system

Test animals

Species:

human

Strain:

not specified

Sex:

male/female

Details on test animals and environmental conditions:

Participants ranged in age from 18-85 years old. Participants by sex: 37 males, 360 females.

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

other: epicutaneous semiocclusive to occlusive

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

0.2 ml of each test substance was used.

Challenge

Challenge 1

Route:

other: epicutaneous semiocclusive to occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

Concentration / amount:

0.2 ml of each test substance was used.

No. of animals per dose:

37 males, 360 females

Details on study design:

Occlusive or semiocclusive patches applied to the infrascapular area of the back, either to the right or left of the midline. Subjects removed patches at 24 hrs, and new patches were applied at 48 hrs. Induction phase consisted of 9 consecutive applications of 0.2 ml test material. After a two-week rest phase, the challenge phase was initiated. Subjects removed patches 24 hrs after application and sites were graded at 48 and 72 hrs after application.

Dermal application with occlusive patch (nonporous plastic film adhesive bandage) or semiocclusive patch (2 cm x 2 cm Webril pad affixed with Scanpor tape).

Grading scale: No reaction; doubtful response, barely perceptible erythema, only slightly different from surrounding skin; definite erythema, no edema; definite erythema, minimal or doubtful edema; definite erythema, definite edema; definite erythema, definite edema and vesiculation.
Reaction was scored at 48 and 72 hours, and the strongest reaction is used in calculating the irritancy score.

Challenge controls:

Non-treated sections of skin used as control

Positive control substance(s):

not specified

Results and discussion

Positive control results:

Not appropriate

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.2 ml of 100%

No. with + reactions:

7

Total no. in group:

397

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.2 ml of 100%

No. with + reactions:

0

Total no. in group:

395

Any other information on results incl. tables

No evidence of sensitization with TTEG.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

TTEG was not a human skin sensitizer.

Executive summary:

The dermal sensitization potential of tetraethylene glycol was examined in humans. The substance was applied (0.2 ml) semiocclusively or occlusively to the skin of 397 individuals every 48 hours for 9 applications. Subjects removed patches after 24 hours. After a two-week rest phase, the challenge phase was initiated. Subjects removed patches 24 hrs after application and sites were graded at 48 and 72 hrs after application.

TetraEG was not a human skin sensitizer.