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EC number: 203-989-9 | CAS number: 112-60-7
- 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
The dermal irritation of tetraethylene glycol was examined in humans and in animals. In rabbit, there was no dermal irritation observed in key studies. A group of 103 humans received 0.2 ml applied occlusively to the infrascapular area of the back, either to the right or left of the midline for 48 hours. Subjects were examined at the end of the 48 hour period and 24 hours later. The primary irritation index was 15.5, indicating minimal irritation.
The eye irritation potential of tetraethylene glycol was examined in rabbits. Instillation of 0.1 ml of sample into rabbit eyes produced minor, transient irritation which did not involve the cornea. Conjunctiva score was 1.7 one hour after dosing and was reversible within 24 hours in one study, in a second study, conjunctival irritation resolved within 8 days (no evidence that the animals were examined between 24 hours and 8 days).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified but between 9 Dec 1985 and 6 April 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The report does not specify about GLP/Guideline but sufficient data is available for interpretation of results
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Male or female rabbits may be used. The animals are maintained on appropriate commercial diet and municipal water.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hr
- Observation period:
- 10 days.
- Number of animals:
- 6
- Details on study design:
- Male or female New Zealand White rabbits are dosed with 0.5 ml. The dose is applied to the clipped, intact skin under a gauze patch and is loosely covered with impervious sheeting. The test material is applied to each of 6 rabbits, which are restrained for the 4-hr contact period. Excess sample is removed after contact. Skin reaction is scored, by the method of Draize, at one hour, one day, 2 days, 3 days, 7 days, and 10 days after dosing.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hr post dosing
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: same score observed after 1, 2, 3, 7 and 10 days.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hr post dosing
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: same score observed after 1, 2, 3, 7 and 10 days.
- Irritant / corrosive response data:
- There was no erythema, eschar and edema observed in any of the rabbits exposed for 4 hours for tetraethylene glycol.
- Other effects:
- There were no other effects noted in rabbits exposed for 4 hours for tetraethylene glycol.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- A 4-hour application of tetraethylene glycol to covered rabbit skin resulted in no irritation.
- Executive summary:
The effects of 4 hour dermal exposure of tetraethylene glycol to rabbit skin was examined. There was no irritation or any other effects noted in rabbits dermally exposed to tetraethylene glycol for 4 hours.
Reference
No additional information available.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified but between 9 Dec 1985 and 6 April 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The report does not specify about GLP/Guideline but sufficient data is available for interpretation of results
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No additional information available.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Yes, other eye
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Since fluorescein is used 24 hours after dosing, the eye is washed at that time. Thus duration is for 24 hours
- Observation period (in vivo):
- Up to 7 days.
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- Male or female New Zealand White rabbits are dosed with volumes of 0.1 ml. The dose is instilled into the lower conjunctival sac of one eye per animal or is placed directly on the eye. The eyelids are held together for one second. Six eyes are dosed per test volume. The eyes are scored at one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing. Fluorescein (2%) staining is used to determine corneal injury before dosing and at readings after one day.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Following application of 0.1 ml test material into the eye of rabbits, minor, transient irritation which did not involve the cornea was observed..
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Score represents mean discharge value. See Table 1 for other conjunctival endpoints examined.
- Irritant / corrosive response data:
- In 6 rabbit eyes, 0.1 ml of sample produced no corneal injury. Iritis developed in all 2 eyes by one hour but did not persist at 4 hours. Minor conjunctival irritation was observed in all 6 eyes. After 24 hours, there was no ocular irritation evident in any rabbit.
- Other effects:
- No additional information available.
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Instillation of 0.1 ml of sample into rabbit eyes produced minor, transient irritation which did not involve the cornea.
- Executive summary:
The eye irritation potential of tetraethylene glycol was examined in rabbits. Instillation of 0.1 ml of sample into rabbit eyes produced minor, transient irritation which did not involve the cornea.
Reference
Table 1 Primary Eve Irritation-Rabbit
Observation Times, Mean (Range) | ||||||
1 hr | 4 hr | 24 hr | 48 hr | 72 hr | 7 days | |
Cornea - Opacity | 0.0 (All 0) |
0.0 (All 0) |
0.0 (All 0) |
0.0 (All 0)
|
0.0 (All 0) |
0.0 (All 0) |
- Area |
0.0 (All 0) |
0.0 (All 0) |
0.0 (All 0) |
0.0 (All 0) |
0.0 (All 0) |
0.0 (All 0) |
Iris - Injury |
0.3 (0 to 1) |
0.0 (All 0) |
0.0 (All 0) |
0.0 (All 0) |
0.0 (All 0) |
0.0 (All 0) |
Conjunctivae - Redness |
1.0 (All 1) |
1.0 (All 1) |
0.0 (All 0) |
0.0 (All 0) |
0.0 (All 0) |
0.0 (All 0) |
- Chemosis |
0.7 (0 to 2) |
0.3 (0 to 1) |
0.0 (All 0) |
0.0 (All 0) |
0.0 (All 0) |
0.0 (All 0) |
- Discharge |
1.7 (1 to 3) |
1.0 (All 1) |
0.0 (All 0) |
0.0 (All 0) |
0.0 (All 0) |
0.0 (All 0) |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
The dermal irritation of tetraethylene glycol was examined in humans and in animals. In the rabbit, there was no dermal irritation observed (scores of 0.0) in key studies. A group of 103 humans received 0.2 ml of TTEG that was applied occlusively to the infrascapular area of the back, either to the right or left of the midline for 48 hours. Subjects were examined at the end of the 48 hour period and 24 hours later. The primary irritation index was 15.5 out of 118, indicating minimal irritation.
The eye irritation potential of tetraethylene glycol was examined in rabbits. Instillation of 0.1 ml of sample into rabbit eyes produced minor, transient irritation which did not involve the cornea. Conjunctival irritation resolved within 24 hours in one study, in a second study, within 8 days (no evidence that the animals were examined between 24 hours and 8 days).
Although dermal and eye irritation was noticed, the effects were very minimal.
Justification for selection of skin irritation / corrosion
endpoint:
Well conducted study with enough experimental detail and in
accordance to guidelines.
Justification for selection of eye irritation endpoint:
Well conducted study with enough experimental detail and in
accordance to guidelines.
Effects on skin irritation/corrosion: slightly irritating
Effects on eye irritation: slightly irritating
Justification for classification or non-classification
As both dermal and eye irritation effects were minimal, if any, classification according to GHS and the Directive 67/548/EEC (DSD) regarding skin or eye irritation is not warranted.
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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