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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
Endpoint summary
Administrative data
Description of key information
Multiple studies available indicating results from no irritancy to slight skin irritancy.
Multiple studies available indicating results from no irritancy to slight eye irritancy (mild conjunctival redness only, resolved within 72 hours)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically reliable study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Box reason, conventional breeding
- Age at study initiation: 3 - 5 Months
- Weight at study initiation: 2.1 - 2.5 kg
- Housing: in a fully air-conditioned rooms in individual cages (Battery cages)
- Diet: Altromin 2123 maintenance diet - rabbit Altomin GmbH, Lage / Lippe, ad libilum and hay (approximately 15g per day)
- Water: deionized, chlorinated water from automated watering ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 50 +/- 20%
- Photoperiod: 12 hours a day - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 ml of the undiluted substance.
- Duration of treatment / exposure:
- 4 hours.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 24 hours prior to the experiment start 3 rabbits in the dorsal region were of trunk with an electric hair clipper with an area of approximately 25 cm2 depilated. Only animals with intact skin were used.
- Type of wrap if used: Each animal was given a wound plaster with 2.5 x 2.5 cm coarse pulp edition (special design the company, Beiersdorf AG, Hamburg) were prepared and fixed on the skin site. Area was then covered with a semiocclusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the remaining was test substance was gentlyremoved with tap water. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hour observations
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hour observations
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
In a guideline skin irritation study, the substance methyl tetraglycol caused no irritation over the observation period 24 -72 hours following application of the substance.
- Endpoint:
- skin irritation: in vivo
- 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 study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- No further information available.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.5 - 2.6 kg
- Housing: In individual cages in air-conditioned spaces (Battery cages
- Diet: Altromin 2123 Haltungsdilt - rabbits Altromin GmbH Lage / Lippe, ad llbitum and hay (about 15g)
- Water: deionized water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C
- Humidity: 50 +/-20 %
- Photoperiod: 12 hours a day - Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- Dorsal area
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- No further information available.
- Number of animals:
- 3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- no data
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Executive summary:
In a well reported guideline study skin irritation study, no effects were seen with the substance 2 -(2 -(2 -methoxyethoxy)ethoxy)ethanol.
Referenceopen allclose all
One hour after removal of the patch was barely visible on two animals. Erythema observed. 24 hours after the administration no symptoms of irritation were observed.
Time after removal of patch | 1 hr | 24hr | 48hr | 72hr |
Animal number | 1 2 3 | 1 2 3 | 1 2 3 | 1 2 3 |
Erythema and Eschar | 1 1 0 | 0 0 0 | 0 0 0 | 0 0 0 |
Oedema | 0 0 0 | 0 0 0 | 0 0 0 | 0 0 0 |
Time after removal of patch | 30 - 60 minutes | 24 hours | 48 hours | 72 hours |
Animal number | 1, 2 & 3 | 1, 2 & 3 | 1, 2 & 3 | 1, 2 & 3 |
Erythema and eschar | 0, 0, 0 | 0, 0, 0 | 0, 0, 0 | 0, 0, 0 |
Edema | 0, 0, 0 | 0, 0, 0 | 0, 0, 0 | 0, 0, 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- 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 study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Box reason, conventional breeding
- Age at study initiation: 3 - 5 Months
- Weight at study initiation: 3.1 - 4.4 kg
- Housing: in air-conditioned rooms in individual cages (Battery cages)
- Diet: Altromin 2123 Haltungsdiat - rabbits Altromin GmbH, Lage / Lippe, ad libitum and hay (about 15g daily)
- Water: deionized, chlorinated water from autonomic watering, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3°C
- Humidity: 50 +/- 20%
- Photoperiod: 12 hours a day - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye in each case served as a control
- Amount / concentration applied:
- 0.1 ml of methyltetraglycol was given as a single dose in the conjunctival sac of the left eye.
- Observation period (in vivo):
- The assessments of the eyes were made 1, 24, 48 and 72 hours after application of the test substance.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
In a guideline eye irritation study using the substance methyltetraglycol, no corneal, iris or chemosis response was seen. Slight conjunctival redness was seen with an average score of 0.33 across the three observation timepoints of 24, 48, and 72 hours, but these effects fully resolved across all three animals by the time of the 48 hour observation. On this basis, the substance is regarded as not irritating for classification purposes.
- Endpoint:
- eye irritation: in vivo
- 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 study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.8-3.l kg
- Housing: in a fully air-conditioned rooms in Einzelkafigen (Battery cages)
- Diet: Altromin 2123 Haltungsdiit - rabbits Altromin GmbH, Lage / Lippe, ad libitum and hay (about two cups of coffee 15g)
- Water: deionized, chlorinated water from automatic watering entities, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C
- Humidity: 50 ± 20 %
- Photoperiod: 12 hours a day - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye was used in each case as a control.
- Amount / concentration applied:
- 0.1 ml of triethylene was applied once into the conjunctival sac of the left eye.
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- No data
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.56
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
In a guideline eye irritation study using the substance 2 -(2 -(2 -methoxyethoxy)ethoxy)ethanol, no corneal, iris or chemosis response was seen. Slight conjunctival redness was seen with an average score of 0.55 across the three observation timepoints of 24, 48, and 72 hours, but these effects fully resolved across all three animals by the time of the 72 hour observation. On this basis, the substance is regarded as not irritating for classification purposes.
Referenceopen allclose all
An hour after the administration revealed the conjunctiva and slight swelling markedly injected blood vessels. 24 hours post-administration the conjunctiva of two animals showed distinct hyperemia of blood vessels and diffuse staining crimson were observed. 48 post-adiminstration all irritative symptoms had fully reversed.
Individual findings |
Time post application | 1h | 24h | 48h | 72h |
Animal number | 1 2 3 | 1 2 3 | 1 2 3 | 1 2 3 |
Conjunctival swelling | 1 1 0 | 0 0 0 | 0 0 0 | 0 0 0 |
Conjunctival redness | 1 1 1 | 2 0 1 | 0 0 0 | 0 0 0 |
Iris | 0 0 0 | 0 0 0 | 0 0 0 | 0 0 0 |
Cornea | 0 0 0 | 0 0 0 | 0 0 0 | 0 0 0 |
Fluorescein Test | 0 0 0 | 0 0 0 |
INDIVIDUAL FINDINGS:
Time post-application | 1h | 24h | 48h | 72h |
Animal number | 1 2 3 | 1 2 3 | 1 2 3 | 1 2 3 |
conjunctival swelling | 1 1 1 | 0 0 0 | 0 0 0 | 0 0 0 |
conjunctival redness | 1 2 1 | 1 1 2 | 0 0 1 | 0 0 0 |
Iris | 0 0 0 | 0 0 0 | 0 0 0 | 0 0 0 |
Corneal opacity | 0 0 0 | 0 0 0 | 0 0 0 | 0 0 0 |
Fluorescein-Test | 0 0 0 | 0 0 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A number of valid skin irritation studies are available using the substances methyl triglycol and methyl tetraglycol, two major components of this UVCB/multicomponent substance, and mixtures containing significant amounts of these substances. The majority of the animal studies using rabbits indicate no irritation response, although some indicate transient response, primarily erythema with no odema seen. A human volunteer study also showed a slight irritation response.
A number of valid eye irritation studies are available using the substances methyl triglycol and methyl tetraglycol, two main components of this UVCB/multicomponent substance, and mixtures containing significant amounts of these substances. These show consistent results with no observable iritis, corneal effects or chemosis observed at any observation point. The only observed effect is mild to moderate transient conjunctival redness (maximum observed value in any animal score 2, with average values in the range 0 to 0.6). These effects are consistently resolved within 72 hours.
Based on observations from the lower members, higher molecular weight species in this homologous series of polyalkylene glycol methyl ethers will show similar potential for irritancy so these results can be considered representative of this UVCB/multicomponent substance. These conclusion for skin and eye irritancy potential are supported by the read across justification document attached to chapter 13 of the lead registrant's dossier.
Justification for classification or non-classification
SKIN IRRITATION: Of those studies available that provide sufficient information to compare to the classification criteria, the data indicate that the response required to trigger classification for acute skin irritation effects is not met. This is confirmed by the response in humans. Classification is clearly not required.
EYE IRRITATION: Of those studies available that provide sufficient information to compare to the classification criteria, the data indicate that the response required to trigger classification for acute skin irritation effects is not met. Only mild and transient conjunctival redness is seen and this effect normally resolves within 72 hours or less. Classification is clearly not required.
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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