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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989
Reference Type:
publication
Title:
SIDS Dossier on the HPV Chemical Triethylene Glycol.
Author:
OECD HPV Chemical Programme, SIDS Dossier
Year:
2007
Bibliographic source:
OECD SIDS
Report date:
2007

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
To determine the ability of the test substance to sensitize the skin of normal volunteers using occlusive and semi-occlusive repeated insult patch test.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-(ethylenedioxy)diethanol
EC Number:
203-953-2
EC Name:
2,2'-(ethylenedioxy)diethanol
Cas Number:
112-27-6
Molecular formula:
C6H14O4
IUPAC Name:
2-[2-(2-hydroxyethoxy)ethoxy]ethan-1-ol
Test material form:
liquid

Method

Type of population:
not specified
Subjects:
- Number of subjects exposed: Three-hundred-ninetyseven (397) subjects completed the study
Number of subjects enrolled: 433
Females: 391
Males: 42

Number of completed cases: 397
Females: 360
Males: 37

Age Range (completed cases): 18-85
Females: 18-77
Males: 19-85
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: Repeated insult patch test

ADMINISTRATION
- Type of application: occlusive and Semi- occlusive
- Description of patch:
Occlusive: Non-Porous, plastic film adhesive bandage with a 2 cmx 2cm Webril pad affixed with Scanpor tape as needed.
Semi- Occlusive: 2cm x2cm Webril pad affixed with Scanpor tape
- Volume applied: 0.2mL
- Procedure: The entire study extended over a six week period. It involved three phases: (1) Induction, (2) Rest, and (3) Challenge. Prior to study entry, the subjects were screened to assure that they met the inclusion/exclusion criteria. Informed consent was obtained. Each subject was provided with a schedule of the study activities. They were told to avoid wetting the test sites and were asked not to engage in activites that caused excessive perspiration. They were instructed to notify the staff if they experienced any discomfort beyond mild itching and/or obsered any adverse changes at the test sites, while on the study or within two weeks of completing the study.
The Induction Phase consisted on nine consective applications of the test material and subsequent evaluations of the test sites. Prior to application of the patches, the sites were outlined with a skin marker, e.g., gential violet. The subjects were required to remove the patches approximately twenty-four hours after application. They returned to the facility at forty-eight hour intervals to have the sites evalutated and identical patches reapplied. Patches were applied on Friday were removed by subjects after twenty-four hours and sites were evaluated on the following Monday, i.e. 72 hours after patch application. Following the ninth evaluation, the subjects were dismissed for a fourteen day rest period.
The Challenge Phase was initiated during the sixth week of the study, with identical patches applied to sites previously unexposed to the test material. These patches were removed by subjects after 24 hours and the sites graded after additional 24 hour and 48 hour periods (i.e. 48 and 72 hours after application.

EXAMINATIONS
- Grading/Scoring system: The symbols found in the computer data accompanying this report are used to express the response observed at the time of examination:
- No reaction
? Doubtful response, barely perceptible erthema, only slightly different from surrounding skin
+* Definite erythema; Minimal or doubtful edema
++ Definite erythema; Definite edema
+++ Definite erythema; Definite edema & vesiculation
X Subject absent
NA Not Applied

Results and discussion

Results of examinations:
The test substance was tested to determine their ability to sensitize the skin of normal volunteer subjects using occlusive and semi-occlusive repeated insult patch tests. Four-hundred-thirty-three (433) subjects were enrolled and three-hundred-ninety-seven (397) subjects completed the study. Twenty (20) subjects (Subject Nos. 05142, 05792, 06333, 06371, 06372, 06373, 06381, 06384, 09895, 09948, 09959, 11830, 11969, 12428, 12481, 12591, 12592, 13457, 13723 and 13807) discontinued for personal reasons. Fifteen (15) subjects (Subject Nos. 05823, 06265, 06283, 06387, 09390, 09866, 09962, 11336, 11834, 11971, 12987, 12991, 13808, 13853 and 13859) were discontinued due to non-compliance. One (1) subject (Subject No. 09960) was discontinued due to a rash. The subject was examined by the Consulting Dermatologist approximately ten (10) days after the onset of the symptoms. The rash had begun on the trunk and extremities and spread over the back by the time of examination. The subject chose not to see a dermatologist and later reported that the condition had cleared. The Consulting Dermatologist indicated that the rash was not related to the test products.
Under the conditions employed in this study, there was no evidence of sensitization to the test substance.

Any other information on results incl. tables

Summary Reaction Data

                               Induction     Challenge
 Grade  1  2  3  4  5  6  7  8  9    1  2
 -  320  292  298  279  306  327  318  312  332    357  366
 ?  78  92  111  119  92  68  73  77  61    33  28
 +  19  16  5  9  7  8  4  8  8    7  1
 +*  0  0  0  0  0  0  0  0  0    0  0
 Tot Readings  417  400  405  407  405  403  395  397  401    397  395
 # Absent  16  33  28  26  28  30  38  36  32    36  38
 Tot Subjects  433  433  433  433  433  433  433  433  433    433  433

Applicant's summary and conclusion

Conclusions:
Under the conditions employed in this study, there was no evidence of sensitization to the test substance.
Executive summary:

Triethylene Glycol (CAS # 112-27-6) was tested to determine it's ability to sensitize the skin of normal volunteer subjects using occlusive and semi-occlusive repeated insult patch tests. Three-hundred-ninetyseven (397) subjects completed the study.

Under the conditions employed in this study, there was no evidence of sensitization.