Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-953-2 | CAS number: 112-27-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Sensitisation data (human)
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:
- 1 989
- Report date:
- 1989
- Reference Type:
- publication
- Title:
- SIDS Dossier on the HPV Chemical Triethylene Glycol.
- Author:
- OECD HPV Chemical Programme, SIDS Dossier
- Year:
- 2 007
- 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
- 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
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.