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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-940-1 | CAS number: 112-15-2
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Jun - 20 Jul 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 1981
- Deviations:
- yes
- Remarks:
- no positive control data for reliability check was included
- Principles of method if other than guideline:
- Method: Maximisation Test according to Magnusson-Kligman (J. Invest. Dermatol. 52: 268-276, 1969)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was initiated prior to the introduction of the LLNA
Test material
- Reference substance name:
- 2-(2-ethoxyethoxy)ethyl acetate
- EC Number:
- 203-940-1
- EC Name:
- 2-(2-ethoxyethoxy)ethyl acetate
- Cas Number:
- 112-15-2
- Molecular formula:
- C8H16O4
- IUPAC Name:
- 2-(2-ethoxyethoxy)ethyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Ethyldiglykolacetat
- Physical state: liquid
- Analytical purity: 99.8%
- Density: 1.01 g/cm³
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino (Bor: DHPW)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Mean weight at study initiation: 391 g (test group), 387 g (control group)
- Housing: 1-5 animals in Makrolon cages type IV
- Diet: G4 Alleindiät für Meerschweinchen, Ssniff Spezialfutter GmbH, Soest; ad libitum
- Water: tap water; ad libitum
- Acclimation period: 5-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.5%
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test group: 20
Control group: 10 - Details on study design:
- RANGE FINDING TESTS:
Epicutaneous treatment with 100% of the test substance did not cause any irritation in a pre-test.
MAIN STUDY
A1. INDUCTION EXPOSURE (day 1; intradermal)
- No. of exposures: 3 pairs of injections with 0.1 mL each (1) Freunds Complete Adjuvant (FCA)/H2O; 2) 0.5% test substance in H2O; 3) 0.5% test substance in FCA/H2O)
- Test groups: 0.5% test substance
- Control group: same treatment without test substance; only vehicle and/or FCA
- Site: upper back
- Frequency of applications: 1
- Concentrations: 0.5%
A2. INDUCTION EXPOSURE (day 8; epidermal)
- Pretreatment: 24 before treatment, the application site was treated with 10% SLS in vaseline to provoke slight irritation.
- No. of exposures: 1
- Exposure period: 48 h, occlusive
- Test groups: 100% test substance
- Control group: 0% test substance
- Site: upper back
- Frequency of applications: 1
- Duration: 48 h
- Concentrations: 100%
B. CHALLENGE EXPOSURE (day 22; epidermal)
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24 h, occlusive
- Test groups: 100% test substance
- Control group: 100% test substance
- Site: left flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction, intradermal: 0.5%; induction, epidermal: 100%, challenge, epidermal: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction, intradermal: 0.5%; induction, epidermal: 100%, challenge, epidermal: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction, intradermal: 0.5%; induction, epidermal: 100%, challenge, epidermal: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction, intradermal: 0.5%; induction, epidermal: 100%, challenge, epidermal: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction, intradermal: 0%; induction, epidermal: 0%, challenge, epidermal: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction, intradermal: 0%; induction, epidermal: 0%, challenge, epidermal: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction, intradermal: 0%; induction, epidermal: 0%, challenge, epidermal: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction, intradermal: 0%; induction, epidermal: 0%, challenge, epidermal: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Body weights and body weight gain were comparable to the control group during the study.
Local reactions after induction:
- Intradermal: One hour after intradermal induction, all FCA-treated animals showed erythema and edema at the site of injection. After 24 h additional necrosis was seen. Erythema were seen at the other injection sites after 1 and 24 h.
- Epidermal: All test and control animals showed erythema and edema at the application site after 1 h, including bloody inflammation of all FCA-treated injection sites as well as agitation and scratching. After 24 h erythema and edema and incrustation of the inflammation sites were still present in all animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
DSD: not classified - Executive summary:
Dermal sensitisation has been investigated in the guinea pig using the maximisation test of Magnusson and Kligman. No evidence of sensitisation to the substance was noted.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)