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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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 substances are either components of this multi-constituent substance or contain members of the same homologous series (ethylene glycol methyl ethers.). Physicochemical properties are very similar. One of the source substances is a mixture where one of the main components is the target substance (35-40%). This if nothing else helps justify bridging. It is assumed that there is no interaction between the components of the multi-constituent substance and that therefore the data from the components individually can be used to predict the properties of the two components when in combination .
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
Source: Tetraethylene glycol methyl ether (TetraEGME) Triethylene glycol methyl ether (TEGME) and a formulated brake fluid. The latter is primarily a mixture of 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%)
Impurities: Both the source and target substances will contain the same impurities as they are produced in the same process, therefore they will have similar impurity profiles and impurities will not impact on the validity of the read across. The formulated brake fluid contains members of the butyl glycol ethers, but the presence of these would not lead to an underestimation of toxicity.
3. ANALOGUE APPROACH JUSTIFICATION
See hypothesis above.
4. DATA MATRIX
Oral (TEGME and TetraEGME). Multiple studies indicate the LD50 exceeds 10,000mg/kgbw. Dot 4: Limit test indicates LD50>2000mg/kgbw
Using data from TetraEGME to predict the toxicity of a multi-constituent of Tetra and PentaEGME therefore appears to be a justified approach. It is sufficient to provide the data required for this end point and to determine classification outcomes.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- October 1991 - March 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- GLP OECD Guideline study. Restriction due to testing on a mixture rather than pure substance.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- not applicable
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- As the material rapidly hydrolyses in the presence of water, the test substance can be considered to be a predominantly mixture of TEGME and TetraEGME.
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were acclimated for five days in stainless steel cages with up to three rats/cage. Food and drinking water were provided ad libitum. Experimental rooms were maintained at 19-23C and 30-70% humidity on a 12-hour light cycle.
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Animals were fasted overnight prior to dosing, and were given a single oral dose of test material at 5000 mg/kg.
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- After the single dose, animals were clinically observed six times on the day of dosing, and twice daily thereafter for 14 days. Necropsies were performed on day 15 and gross pathological lesions recorded.
- Statistics:
- not applicable
- Preliminary study:
- None of the animals died. Clinical signs included abasia/ataxia, hunched posture, piloerection, lachrymation, and later unkempt appearance with staining/soiling of fur in the anogenital region. Less common signs included lethargy in males, and bradypnea in female. Signs started to be evident after one hour, and resolution began to be seen by day 2 and recovery was complete by day 8 in all animals.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- None
- Clinical signs:
- other: Clinical signs included abasia/ataxia, hunched posture, piloerection, lachrymation, and later unkempt appearance with staining/soiling of fur in the anogenital region. Less common signs included lethargy in males, and bradypnea in female.
- Gross pathology:
- No pathology was found.
- Other findings:
- Not applicable
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Brake FLuid DOT4 is not expected to present an acute toxicity hazard by the oral route
- Executive summary:
Male and female Fisher 344 rats were exposed to 5000 mg/kg Brake Fluid DOT4 and observed for 14 days. No mortality was observed. Transient clinical signs included abasia/ataxia, hunched posture, piloerection, lachrymation, and later unkempt appearance with staining/soiling of fur in the anogenital region. Less common signs included lethargy in males, and bradypnea in female. Body weight gain was not affected by treatment.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1960-1962
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Study report with basic details reported but sufficient to judge as reliable for inclusion.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Follows basic principles of an OECD401 but there is insufficient information to rank it as 'equivalent or similar'. A number of the observations normally now required are not reported.
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Carworth Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Own colony
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 90-120g
- Fasting period before study: not fasted
- Diet : Rockland rat diet - Route of administration:
- oral: gavage
- Vehicle:
- other: see other information.
- Doses:
- 4, 8, 16ml/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- other: A number of other substances were also tested in the same study
- Details on study design:
- - Duration of observation period following administration: 14 days
-Autopsies were performed on rats that died.
- Surviving rats were weighed at study termination. - Statistics:
- LD50 value and precision estimated by method of Thompson (Bacteriol Rev, 11, 115, 1947) and tables of Weil (Biometrics, 8, 249 ,1952) (the method of moving average).
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 11.3 mL/kg bw
- Mortality:
- 100% in top dose group, none in lower dose groups.
- Gross pathology:
- Animals that died showed congested lungs, mottled livers and kidneys and gastrointestinal tract irritation. The adrenals were slightly congested.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Substance of low toxicity by the oral route.
- Executive summary:
In an old study report where all basic experimental details were reported, an LD50 of 11.3ml/kg was established in male rats.
Synopsis
LD50 (male rats) = 11.3ml/kg
Individual animal results:
Dose (ml/kg) |
Mortality |
Day of death |
Average weight gain (g) |
16 |
5/5 |
All day 1 |
|
8 |
0/5 |
- |
42.6 (SD=7.0) |
4 |
0/5 |
- |
31 (30)* |
*One animal showed weight loss, one limited weight gain
LD50 is equivalent to 10500mg/kg
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Scientifically reliable.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Fasting period before study: Approx. 16 hours before
- Diet: animals were deprived of food approximately 3-4 hours after application
- Water: Executive Board Swiss in plastic drinking bottles ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 50+/-20 %
- Photoperiod: 12 hours a day - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The temporal onset of symptoms was recorded. During this time the weight of the animals was determined.
.- Necropsy of survivors performed: yes, the Animals were killed at the end of follow-through using carbon dioxide, dissected, and examined for macroscopically visible changes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths occurred from exposure to a lethal dose of 2000 mg/kg.
- Clinical signs:
- other: In addition to nonspecific symptoms, the animals showed an impairment of breathing and movement processes. These symptoms reversed within 3 days.
- Gross pathology:
- In the male showing a lag time in body weight gain, a deformation of the skull was found, macroscopically found a strongly reduced blood pooling in the brain and skull. A compound related effect was not apparent.
- Other findings:
- Squatting, and uncordinated legged gait, and irregular breathing was observed in females.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information No data Criteria used for interpretation of results: EU
- Executive summary:
In a guideline and GLP acute toxicitystudy , the LD50 of the substance methyltetraglycol was established to be above the single tested dose of 2000mg/kg.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 19 Feb 1974 - 01 Mar 1974
- 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 401 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Method: BASF-Test which follows in principle the methods described in OECD Guideline 401.
5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in water. Group-wise documentation of clinical signs was performed over the 7 day study period. The clinical signs and findings were reported in summary form. - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male: 186g (mean), female 165g (mean) - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 35% for 10500 mg/kg and 15% for 1050 and 2257 mg/kg - Doses:
- 1050, 2257, 10500 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female rats per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes - Statistics:
- On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 500 mg/kg bw
- Mortality:
- no mortality occured.
- Clinical signs:
- other: Signs of toxicity comprised at 10500 mg/kg: apathy, spastic gait, dyspnea, mouth and eyelid crust formation.
- Gross pathology:
- At necroscopy no abnormalities were observed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
In an acute oral toxicity study that followed the basic requirements of the OECD standard protocol guideline, male and female rats were exposed to single gavage doses of 2 -(2 -(2 -methoxyethoxy)ethoxy)ethanol at doses up to 10500mg/kg. The high dose animals showed apathy, spastic gait, dyspnea, mouth and eyelid crust formation and males also showed a sharp but transient drop in body. However, no mortality was reported implying that the LD50 is significantly in excess of the maximum dose tested.
Synopsis
LD50 (male, female) >10500mg/kg
Mean Body weights (g) MALES:
Dose group (mg/kg) |
Day 0 |
Day 3 |
Day 7 |
1050 |
190 |
210 |
205 |
2257 |
199 |
228 |
222 |
10500 |
169 |
124 |
159 |
Mean Body weights (g) FEMALES:
Dose group (mg/kg) |
Day 0 |
Day 3 |
Day 7 |
1050 |
165 |
184 |
167 |
2257 |
163 |
178 |
170 |
10500 |
168 |
192 |
178 |
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: oral
- 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
- Remarks:
- Scientifically reliable.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- No further information available.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 98 - 116 g (average weight 109 g)
- Fasting period before study: 16 hours
- Housing: wood shavings
- Diet (e.g. ad libitum): 2 hours after administration of the product the animals were again given food. The animals received as lining the lialtungsdiät Altromin Altromin 1324 the Company GmbH, Lage / Lippe ad libitum
- Water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- Single dose
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes, after the end of follow-up rats were killed under anesthesia, dissected and macroscopically evaluated. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 15 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1/10 died.
- Clinical signs:
- other: Animals exposed to 15,000 mg/kg exhibited staggering gait, ruffled fur, gasping respiration
- Gross pathology:
- The autopsy of the deceased animal at the end of test was macroscopically evaluated without specific findings.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Executive summary:
In an acute oral toxicity study in rats that approximated to guideline, an LD50 of >15000mg/kg was established for the substance methyl tetraglycol.
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
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 10 500 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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