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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 259-910-3 | CAS number: 55934-93-5
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 420 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 4.2
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- see discussion
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1.4
- Justification:
- see discussion
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- see discussion
- AF for other interspecies differences:
- 1
- Justification:
- default
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC default - see discussion
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
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:
- 238 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 16.8
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- see discussion
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1.4
- Justification:
- see discussion
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default - see discussion
- AF for other interspecies differences:
- 1
- Justification:
- default
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC default - see discussion
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
See document entitled "P-series glycol ethers DNELs overview" attached to this endpoint summary for a full overview of the DNELs.
Explanation for the Toxicodynamic factor (TkD)
Across the P-series glycol ethers there are toxicity studies on several different species (rat, rabbit, mouse, guinea pig, monkey, etc.). Where comparable studies are available for the same substance in two or more different species it is clear that there is little difference in the NOELs. For example, for PM there are 90-day repeated dose toxicity studies in rats, rabbits, and mice. The NOEC in each study is 1000 ppm. For DPM there are 28 to 31 week inhalation studies in rats, monkeys, rabbits and guinea pigs. The NOEC for each species is 300 ppm. Based on the consistency in NOELs between species it appears that adjusting for Allometric scaling when deriving the DNELs would be sufficient to address any potential inter species differences. As such it is considered justified to use a factor 1 for the ‘toxicodynamic differences’.
Explanation for the Duration factor
In the 2011 publication of Batke et al. (2011)[1]an analysis of the RepDose database to derive appropriate assessment factors for extrapolating a NOEL from a shorter to a longer term study was presented. The study determined that in many cases the default factors proposed by ECHA are unnecessarily conservative and that in the case of rapidly metabolised substances that do not have the potential to bioaccumulate and have a minimal toxicological fingerprint, lower factors can be used to extrapolate from shorter to longer durations. The data available on the P-series glycol ethers indicates that they are rapidly and extensively metabolised and have no potential for bioaccumulation. As such it is considered justified to use the assessment factors proposed by Batke et al. (2011).
[1]Batke M; Escher S; Hoffmann-Doerr S; Melber C; Messinger H; Mangelsdorf I (2011).Evaluation of time extrapolation factors based on the database RepDose.Toxicol Lett.205(2):122-9
ECETOC Intraspecies Assessment Factor
According to the ECHA guidance document, where scientific justification exists, one can deviate from the default ECHA assessment factors used in DENL derivation. In deriving DNELS, the assessment factor chosen for Intraspecies variability (worker and general population) has been taken from the ECETOC technical report no, 110 as an alternative to the ECHA default. The ECETOC working group performed a detailed assessment of the many publications available on human variability as it pertains to risk assessment. As a consequence of this assessment it was determined that in the majority of cases a factor of 3 for worker or 5 for general population is sufficient to address Intraspecies variability. Specifically considering the p-series glycol ethers, they have a low order of toxicity, with key effects primarily limited to adaptive effects in the liver and kidney (likely associated with either enzyme induction or alpha 2u-globulin formation). These substances also demonstrate very little variability in effect levels and target organs when tested in multiple species and for multiple durations (sub-acute to chronic). As such it is considered that the lower assessment factors proposed by ECETOC should adequately address the Intraspecies variability within the risk assessment.
Worker DNELs
DNELs have been derived for:
· Inhalation, systemic, long term
· Dermal, Systemic, long term
Inhalation, Systemic, Long term
The starting point for the derivation of a DNEL is the 13-week drinking water study in the rat (including 4 week recovery). The NOAEL from this study was considered to be 1000 mg/kg bw/day.
This NOAEL is adjusted to extrapolate from oral to inhalation:
1000/0.38 x 6.7/10 = 1763 mg/m3
Assessment factors:
· Allometric scaling: 1 (addressed in route to route extrapolation)
· Worker variability: 3
· Duration: 1.4 (longer term studies on category members support short term NOAEC)
Total factor used: 4.2
DNEL = 420 mg/m3
Dermal, Systemic, Long term
The starting point for the derivation of a DNEL is the 13-week drinking water study in the rat (including 4 week recovery). The NOAEL from this study was considered to be 1000 mg/kg bw/day.
This NOAEL is adjusted to extrapolate from oral to dermal based on the differences in bioavailability:
1000 x 100/20 = 4000
Assessment factors:
· Allometric scaling: 4
· Worker variability: 3
· Duration: 1.4
Total factor = 16.8
No factor used for ‘other differences’
DNEL = 238 mg/kg bw/day
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 124 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 7
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 870 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- see discussion
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1.4
- Justification:
- see discussion
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- see discussion
- AF for other interspecies differences:
- 1
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC default - see discussion
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
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:
- DNEL (Derived No Effect Level)
- Value:
- 143 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 28
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- see discussion
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1.4
- Justification:
- see discussion
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default
- AF for other interspecies differences:
- 1
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC default - see discussion
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
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:
- DNEL (Derived No Effect Level)
- Value:
- 36 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 28
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- not needed
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1.4
- Justification:
- see discussion
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default
- AF for other interspecies differences:
- 1
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC default - see discussion
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
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
General Population DNELs
DNELS have been derived for:
· Inhalation, systemic, long term
· Dermal, systemic, long term
· Oral, systemic, long term
Inhalation, Systemic, Long Term
The starting point for the derivation of a DNEL is the 13-week drinking water study in the rat (including 4 week recovery). The NOAEL from this study was considered to be 1000 mg/kg bw/day.
This NOAEL is adjusted to extrapolate from oral to inhalation:
1000 / 1.15 = 870 mg/m3
Assessment factors:
· Allometric scaling: 1 (inhalation starting point)
· General population variability: 5
· Duration: 1.4 (longer term studies on category members support short term NOAEC)
Total factor used: 7
DNEL =124 mg/m3
Dermal, Systemic, Long Term
The starting point for the derivation of a DNEL is the 13-week drinking water study in the rat (including 4 week recovery). The NOAEL from this study was considered to be 1000 mg/kg bw/day.
This NOAEL is adjusted to extrapolate from oral to dermal route
1000 x 100/20 = 4000Assessment factors:
· Allometric scaling: 4
· General Population variability: 5
· Duration: 1.4
Total factor = 28
No factor used for ‘other differences’
DNEL = 143 mg/kg bw/day
Oral, Systemic, Long Term
The starting point for the derivation of a DNEL is the 13-week drinking water study in the rat (including 4 week recovery). The NOAEL from this study was considered to be 1000 mg/kg bw/day.
No route to route extrapolation performed
Assessment factors:
· Allometric scaling: 4
· General population variability: 5
· Duration: 1.4
Total factor = 28
DNEL = 36 mg/kg bw/day
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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