Reaction mass of 3,6,9-trioxaundecane-1,11-diol and 2,2'-oxydiethanol and 2,2'-(ethylenedioxy)diethanol and 3,6,9,12-tetraoxatetrade

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Justification for type of information:

Read across is based on the category approach. Please refer to attached category document.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

GLP compliance:

not specified

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'-[oxybis(ethane-2,1-diyloxy)]diethanol

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

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

Clinical history:

Individuals free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, would have interfered with the results.

Controls:

Non treated sections of skin used as control

Route of administration:

dermal

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.

Results and discussion

Results of examinations:

No evidence of sensitization with TTEG.

Applicant's summary and conclusion

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.