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EC number: 915-389-0 | CAS number: -
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The source and target substances or their components are from the same homologous series and contain identical structural groups. All of the groups in the target substances are seen in the source substance. Physicochemical properties are very similar. The source substances are mixtures where one of the main components is the target substance (35-40%).
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Target: Multiconstituent substance of Tetraethylene glycol methyl ether (TetraEGME) and pentaethylene glycol methyl ether (PentaEGME).
Source: Formulated brake fluids. These are primarily mixtures of triethylene glycol methyl ether (TEGME) TetraEGME and pentaEGME that is partially borated. The borate ester hydrolyses rapidly in the presence of water so the test substance for this end point can be considered a mixture of the parent glycol ether and boric acid (4.5%).
3. ANALOGUE APPROACH JUSTIFICATION
See hypothesis above. If the substance had any potential for skin sensitisation, since there is sufficient of the target substance in the source substance (and arguably a very substantial proportion) it would be evident from the testing of brake fluid formulations containing the substance if the substance itself had any sensitising potential.
4. DATA MATRIX
Multiple studies indicate no skin sensitisation potential.
Supporting information is given from a published QSAR that indicates no alerts for skin sensitisation and from other published data that indicate that the E series glycol ethers as a whole do not show any evidence of skin sensitisation potential (ECETOC 2005. The toxicology of glycol ethers and its relevance to man, Technical Report 95, ECETOC, Brussels, 2005). The available information is sufficient to determine the classification requirements for this end point.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- March 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study is similar to OECD guideline regulatory studies, methods are well reported, but study is not GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study does not need to be conducted because adequate reliable data is available from this alternative existing study providing data on the potential for skin sensitisation
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Animals, after acclimatisatino period, were housed 2-3/cage and provided food and water ad libitum. Room was maintained at 19-23C, with 30-70% relative humidity. Light was maintained on a 12-hour cycle.
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 0.6% in FCA (induction)
100% epicutaneous induction phase
60% in challenge - No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.6% in FCA (induction)
100% epicutaneous induction phase
60% in challenge - No. of animals per dose:
- 10/sex for treated animals, 5/sex for the negative control
- Details on study design:
- Range finding test on 2 animals/sex was carried out to determine the maximum concentration for the intradermal induction. Animals were closely shorn in the shoulder region, and two rows of intradermal injections were made on either side of the midline. 0.1 mL of Freund's Complete Adjuvant, 0.1 mL of test material in vehicle, and 0.1 mL of test material in 50:50 FCA/vehicle.
One week after intradermal injections, the same region was again shorn, and 0.3 mL of undiluted test material was applied via moistened filter paper under occlusive bandage and held in place for 48 hours.
Three weeks after the induction phase, the one flank of each animal was shorn, and 0.1 mL of diluted test material applied via filter paper and held in place by occlusive bandage for 24 hours. Reactions were read 24 and 48 hours after patch removal, and graded on a 4 point scale. - Challenge controls:
- Water was used as a negative control
- Positive control substance(s):
- no
- Positive control results:
- not applicable
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 mL 50% dilution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 mL 50% dilution. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 mL 50% dilution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 mL 50% dilution. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Brake FLuid DOT 4 Super is not sensitising
- Executive summary:
Brake Fluid DOT 4 Super was tested for sensitisation in Guinea pigs using the Magnusson and Kligman assay. No evidence of sensitsation was observed, and the formulation was considered to be non-sensitising.
A study using such a formulation is considered relevant to use for this substance since such formulations represent 95% of the end use of this substance.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Study conducted prior to GLP, but follows accepted guidelines and is well reported.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study does not need to be conducted because adequate reliable data is available from this alternative study providing data on the potential for skin sensitisation.
- Species:
- guinea pig
- Strain:
- other: P-strain
- Sex:
- male/female
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 5% for induction phase 1, undiluted for induction phase 2, and 50% challenge phase
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5% for induction phase 1, undiluted for induction phase 2, and 50% challenge phase
- No. of animals per dose:
- 20 (test material); 10 (negative controls)
- Details on study design:
- Induction Phase:
Guinea pigs were shorn in the shoulder region and challenged in 2 rows of 3 intradermal injections each with 0.1 mL Freund's Complete Adjuvant, 5% Brake Fluid 500 DOT 4 in water, or 5% Brake Fluid 500 DOT 4 in 50:50 water: FCA. One week after the intradermal injections, the site was clipped free of hair and a soaked filter paper, covered with overlapping plastic adhesive tape and secured with an elastic bandage and left in place for 48 hours.
Challenge Phase:
Two weeks after topical induction, hair was removed from the site and test material was applied via soaked filter paper, covered with an adhesive tape, and held in place with an elastic bandage for 48 hours. Reactions were read at 24 and 48 hours. - Challenge controls:
- Vehicle (water) was used as negative control
- Positive control substance(s):
- not required
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 19.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Brake Fluid 500 DOT 4 was non-sensitising to Guinea pig skin.
- Executive summary:
Brake Fluid 500 DOT 4, a formulation containing primarily 2 -(2 -(2 -methoxyethoxy)ethoxy)ethanol in borated and non borated form, was tested for skin sensitisation using the Guinea pig Magnusson and Kligman method. No evidence of skin sensitisation was seen in the study.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Prior to GLP
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study does not need to be conducted because adequate reliable data is available from this alternative study providing data on the potential for skin sensitisation.
- Species:
- guinea pig
- Strain:
- other: "P-strain"
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Animal care details not provided in study report
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- 1%
- Route:
- epicutaneous, open
- Vehicle:
- corn oil
- Concentration / amount:
- 1%
- No. of animals per dose:
- 20
- Details on study design:
- Guinea pigs (10/sex for the test material treated animals or 5/sex as controls), were administered the test substance as 1% in corn oil intradermally. Topical induction and challenge were done to test for immediate, 24 and 48 hours responses.
- Challenge controls:
- 5/sex injected with corn oil only
- Positive control substance(s):
- no
- Positive control results:
- not applicable
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- one female died from injection site trauma
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: one female died from injection site trauma.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- corn oil only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: corn oil only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- corn oil only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: corn oil only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Brake Fluid 500 DOT 4 was not sensitising in this Magnusson and Kligman guinea pig sensitisation assay.
- Executive summary:
Guinea pigs (10/sex for the test material treated animals or 5/sex as controls), were administered the test substance Brake Fluid Dot 4,
a formulation containing primarily 2 -(2 -(2 -methoxyethoxy)ethoxy)ethanol in borated and non borated form, as 1% in corn oil intradermally. Topical induction and challenge were done to test for immediate, 24 and 48 hours responses. No evidence of sensitisation was observed.
A study using such a formulation is considered relevant to use for this substance since such formulations represent 95% of the end use of this substance
Data source
Materials and methods
Test material
- Reference substance name:
- 2,5,8,11-tetraoxatridecan-13-ol; 2-[2-(2-methoxyethoxy)ethoxy]ethan-1-ol
- EC Number:
- 915-389-0
- Molecular formula:
- C9H20O5 and C11H24O6
- IUPAC Name:
- 2,5,8,11-tetraoxatridecan-13-ol; 2-[2-(2-methoxyethoxy)ethoxy]ethan-1-ol
Constituent 1
Results and discussion
In vivo (non-LLNA)
Results
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
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.
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