Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 211-074-0 | CAS number: 629-11-8
- 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:
- 35 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
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:
- 10 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
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
Only the DNEL for long-term systemic effects are derived since 1,6-hexanediol is non-irritating and acutely practically non-toxic.
The DNEL for long-term exposure is derived from the observed NOAEL from a 90-day repeated dose toxicity study performed according OECD guideline (BASF SE, 2014). The only effect that has been noted in high-dose males (1000 mg/kg/d) were decreases in body weights. Since no treatment-related effects of toxicological relevance have been observed at 400 mg/kg/d in neither males nor females, this dose is used as starting point for DNEL derivation
Worker:
In general, the DNEL calculation is based on the observed effect level of animal studies which has to be modified.
To correct the interspecies difference between rat and human the NOAEL (400 mg/kg/d) has to be corrected by the risk assessors 0.38 mg/m3 and 6.7 m3/10 m3regarding breathing volume (rat, 8h) and frequency (worker at rest vs. at light activity), respectively. Furthermore, an additional factor of 2 has to be included considering 50% absorption following oral up-take and 100% following inhalation.
Corrected NOAEL = NOAEL / 0.38 mg/m3 x (6.7/10) / 2 = 352,6 mg/m3. Furthermore, according to ECHA guidance document R8 and ECETOC Technical Report No 110, the following assessment factors have to be taken into account:
- intraspecies differences: 5
- exposure duration: 2
- Quality of database: 1
The DNEL is calculated according to the formula DNEL = (corrected starting point)/(overall AF) as stated in R8 (ECHA, May 2008). Thus, the resulting DNEL for systemic long-term inhalative effects of 1,6-hexanediol is therefore 35.26 mg/m3/d for workers.
For the DNEL of systemic oral and dermal effects a correction of the starting point is not required, since the NOAEL was derived in a 90–day repeated dose toxicity study (BASF SE, 2014) and equal absorption following dermal and oral up-take is assumed.
According to ECHA guidance R8 and ECETOC Technical Report No 110, the following assessment factors were taken into account for the final DNEL calculation:
- interspecies differences: 4
- intraspecies differences: 5
- exposure duration: 2
-Quality of database: 1
Based on these assessment factors, the DNEL for systemic long-term dermal effects of hexanediol is 400 mg/kg/d / 40 = 10 mg/kg bw/d for workers.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
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:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 118
- Modified dose descriptor starting point:
- NOAEL
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:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- LOAEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
General population:
With one exception only the DNEL for long-term systemic effects is derived since 1,6-hexanediol is non-irritating and acutely practically non-toxic. To be complete an oral acute DNEL was also calculated.
No mortality but clinical symptoms (staggering) are observed in an oral toxicity study in the rat at 2500 mg/kg. A safety factor of 120 (4 (inter species) x 3 (LOAEL to NAEL) x 10 (intra species) ) was taken into consideration, leading to an oral acute DNEL for consumers of 20.8 mg/kg.
For the calculation of the systemic DNELs, the NOAEL of 400 mg/kg/d derived in a 90 -d repeated dose toxicity study was used as starting point:
To correct the interspecies difference between rat and human the observed effect level has to be corrected by the risk assessors 1.15 m3regarding breathing volume and frequency (rats, 24h). Furthermore, since no experimental data is available, as a worst case approach an oral absorption of 50% and absorption following inhalation of 100% is assumed. Thus, the corrected starting point for the general population is 400 / 1.15 mg/m3 /2 = 173.9 mg/m3/d for inhalation. Subsequently the following assessment factors have to be taken into account for the final DNEL calculation:
- intraspecies differences: 10
- exposure duration: 2.
- Quality of database: 1
The DNEL is calculated according to the formula DNEL = (corrected starting point)/(overall AF) as stated in R8 (ECHA, May 2008). Thus, the resulting DNEL for systemic long-term inhalative effects of hexanediol is 8.7 mg/m3/d for the general population.
For the DNEL of systemic oral and dermal effects a correction of the starting point is not required, since the observed effect level was derived in a 90–day repeated dose toxicity study (BASF SE, 2014) and the same absorption is assumes following oral and dermal up-take. The following assessment factors were taken into account for the final DNEL calculation:
- interspecies differences 4
- intraspecies differences 10
- exposure duration: 2
- Quality of database: 1.
The resulting DNEL for systemic long-term oral and dermal effects of hexanediol is therefore 5 mg/kg bw/d for the general population.
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.