Registration Dossier
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EC number: 205-594-7 | CAS number: 143-24-8
- 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

Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 22 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Technical Report No. 110 Page 62
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 525 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Comparable resorption for oral and inhalation routes; Human body weight of 70 kg/person; Daily respiration volume for a worker of 10 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- A clear dose response relation established in the original study.
- AF for differences in duration of exposure:
- 2
- Justification:
- The exposure duration did not cover the third trimester of pregnancy.
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- The allometric scaling factor for rabbit given as 2.4 in ECHA REACH Guidance.
- AF for other interspecies differences:
- 5
- Justification:
- The number of species investigated is 3 (rabbit, rat and mice), the rabbit being the most sensitive species.
- AF for intraspecies differences:
- 1
- Justification:
- An informed AF of 1 is proposed when using prenatal data for DNEL derivation.
- AF for the quality of the whole database:
- 1
- Justification:
- All data are Klimish 1 or 2. Additional AF for the read-across approach is considered to be not necessary, because it can be reasonably assumed that the NOAEL for the target chemical should be higher than that for the source chemical.
- AF for remaining uncertainties:
- 1
- Justification:
- An informed AF of 1 is proposed; The remaining uncertainties is already ccovered by using AF of 5 for other interspecies differences.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- other: ECETOC (2003) Derivation of Assessment Factors for Human Health Risk Assessment
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Comparable resorption for oral and dermal routes.
- AF for dose response relationship:
- 1
- Justification:
- A clear dose response relation established in the original study.
- AF for differences in duration of exposure:
- 2
- Justification:
- The exposure duration did not cover the third trimester of pregnancy.
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- The allometric scaling factor for rabbit given as 2.4 in ECHA REACH Guidance.
- AF for other interspecies differences:
- 5
- Justification:
- The number of species investigated is 3 (rabbit, rat and mice), the rabbit being the most sensitive species.
- AF for intraspecies differences:
- 1
- Justification:
- An informed AF of 1 is proposed when using prenatal data for DNEL derivation.
- AF for the quality of the whole database:
- 1
- Justification:
- All data are Klimish 1 or 2. Additional AF for the read-across approach is considered to be not necessary, because it can be reasonably assumed that the NOAEL for the target chemical should be higher than that for the source chemical.
- AF for remaining uncertainties:
- 1
- Justification:
- An informed AF of 1 is proposed; The remaining uncertainties is already covered by using AF of 5 for other interspecies differences.
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
According to RIP 3.2.2, Chapter R8, R8.1.2.5, p. 16 no acute DNELs were derived since no acute toxicity hazard has been identified. The long-term DNEL concerning reprotoxic (developmental) effects also covers possible acute toxic effects.
Long-term inhalatory systemic DNEL
- based on NOEL (developmental, oral) in rabbits: 75 mg/kg bw/d
- according to the method mentioned in ECETOC Technical Report No. 110
DNEL (inhal.):
= (NOEL(oral, rabbit) /allometric scaling factor) x human body weight / respiration volume (worker) /assessment factor (unborn child)/additional factor (duration)
= (75 mg/kg bw/d /2.4) x 70 kg / 10 m3/ 5 / 2
= 22 mg/m3
with
NOEL(oral, rabbit): 75 mg/kg bw/d
allometric scaling factor (rabbit to human): 2.4
human body weight: 70 kg
respiration volume (worker): 10 m3
assessment factor (unborn child): 5, considering 3 species (rabbit, rat and mouse) investigated
additional factor (duration): 2, considering the shorter exposure duration than the pregnancy of the species
Long-term dermal systemic DNEL
-based on NOEL (developmental, oral) in rabbits: 75 mg/kg bw/d
-according to the method mentioned in the ECETOC Technical Report No. 110
DNEL (dermal)
= NOEL(oral, rabbit) /allometric scaling factor/assessment factor (unborn child)/additional factor (duration)
= 75 mg/kg bw/d /2.4 / 5 / 2
= 3 mg/kg bw/d
with
NOEL(oral, rabbit): 75 mg/kg bw/d
allometric scaling factor (rabbit to human): 2.4
assessment factor (unborn child): 5, considering 2 species (rabbit and mouse) investigated
additional factor (duration): 2, considering the shorter exposure duration than the pregnancy of the species
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 0.5 µg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- By inhalation
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 1 µg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 1 µg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Use of tetraglyme in consumer product is not supported by the registrant of this dossier. The general population should not be exposed to tetraglyme and a DNEL for the general popublation is not relevant.
Due to the historical reasons the general population exposure may have been occured, however. The threshold values based on the TTC concept provided in this dossier is soley for the purpose of the risk assessment that may have been occured in the past.
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.

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