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EC number: 203-919-7 | CAS number: 111-90-0
- 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:
- key study
- Study period:
- From November 1992 to January 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study following a standard method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1993
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Marzulli and Maibach's method based on induction period (9 applications), rest period (15 days) and challenge phase.
Marzulli F.N. and Maibach H.I. Contact allergy, predictive testing in man. Contact Dermatitis, 1976, 2, 1-17. - GLP compliance:
- no
- Remarks:
- However, study carried out to Good Clinical Practice - GCP
Test material
- Reference substance name:
- 2-(2-ethoxyethoxy)ethanol
- EC Number:
- 203-919-7
- EC Name:
- 2-(2-ethoxyethoxy)ethanol
- Cas Number:
- 111-90-0
- Molecular formula:
- C6H14O3
- IUPAC Name:
- 2-(2-ethoxyethoxy)ethan-1-ol
- Details on test material:
- - Name of test material (as cited in study report):Transcutol
- Physical state:translucent liquid
- Analytical purity:pure
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed:25
- Sex:males or females
- Age:18-70 (the year range 65-70 should not represent more than 10% of the total number of volunteers)
- Race:Caucasian
- Demographic information:Francophone volunteers, able to read the documents they were presented with and to hold to what they were explained.
- Other: the volunteers should be affiliated to a social security organisation. - Clinical history:
- Exclusion criteria included certain medical conditions, pregnancy, nursing, or not able to use medically acceptable contraception, immunological deficit, background of drug intolerance, allergic background, skin disease, febrile illness, some smokers and volunteers having had or being in the course of long-term treatment, in particular with antihistamine, steroids, beta blocker collyriums, of desensitization.
- Controls:
- During the induction period, in parallel to the application of the test article, i.e. on the volunteer's left arm, isolation chambers alone without test article were applied at Day 1 and Day 17 under the same conditions, to act as 'negative' control.
During the challenge period, the test article were applied on the left side of the spine on the back, and the patch tests alone (without test article) were applied under the same conditions in parallel to the test articles to act as 'negative' control (on the right side of the spine). - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch:Finn chambers on Scanpor, delivered by Promedica. It is composed of an aluminium cupule 8mm in diameter covering a contact surfact of 50mm2. Each cupule is individually mounted onto an adhesive tape applied in such a manner as to exert equal pressure on all cupules. The liquid test article were put onto a disc of filter paper (7mm) previously inserted into the cupule.
- Vehicle / solvent:none
- Concentrations: as supplied
- Volume applied:0.02ml
- Testing/scoring schedule:
Induction period - 9 applications on the inside of the left arm, allocated on 3 weeks. Applications were of 48hr exposure (1st, 2nd, 4th, 5th, 7th, and 8th applications) or about 72hours (3rd and 6th applications)
Rest period - From Day 21 to Day 35, i.e. for a 15 day period
Challenge period - Single application at Day 36 on the back. Duration of exposure 48hrs
- Removal of test substance:no data
- Other:
EXAMINATIONS
- Grading/Scoring system:
During induction - Cutaneous examinations was conducted about 30minutes after removal of the patch tests of the 1st and 8th applications of the test articles, and immediately after removal of the patch tests of the 7 other applications.
At challenge - 24 and 48hrs after removal of the patch.
Special attention was paid to the reading carried out after the 1st application, in order to verify the irritative potential of the test articles applied.
- Statistical analysis:none
- Other:
Results and discussion
- Results of examinations:
- No pathological irritation, nor significant sensitisation reaction was noted. The only reaction observed was a soaped-like effect (worn aspect of the skin) in 19 out of the 24 volunteers included in the study.
Any other information on results incl. tables
30 volunteers of both sexes were recruited and selected for the study. 25 came to the center on the day of treatment start and all were included by the Investigator. One of them (a man) abandoned the study on the 12th day.
The final 24 volunteers were 6 women and 18 men.
Applicant's summary and conclusion
- Executive summary:
In a human volunteer insult patch test skin sensitisation study using 2 -(2 -ethoxyethoxy)ethanol, 25 healthy adult healthy volunteers were subjected to nine occlusive 48 -72hr patch applications of 0.02ml of test substance. This was followed by a resting period and a challenge patch to evaluate sensitisation potential. Under these experimental conditions, 2 -(2 -ethoxyethoxy)ethanol did not induce any primary or cumulative irritation, nor any cutaneous sensitisation reaction.
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