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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 447-060-8 | 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
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:
- 3.9 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):
- 225
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 881.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Assuming by default 100% absorption for the inhalation and 50% absorption for oral exposure routes, and standard respiratory volumes of 0.38 m3/kg over 8 hours for rats, 6.7 m3/person over 8 hours and 10 m3/person over 24 hours for humans
- AF for dose response relationship:
- 3
- Justification:
- Use of LOAEL as a starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value for subacute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable due to route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Klimisch 1 study used
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
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:
- 1.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 900
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The starting point (oral LOAEL) was not modified to take account of the ratio between oral absorption in rats and dermal absorption in humans, which are both considered equal to 100% by default, in a worst-case hypothesis
- AF for dose response relationship:
- 3
- Justification:
- Use of LOAEL as a starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value for subacute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Klimisch 1 study used
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
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
DNEL derivation was performed according to the method proposed in the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8.
Acute / short-term or long-term exposure - local effects
For local effects, no sufficient information as to concentration-response relationship of irritation is available to enable DNEL derivation. The irritation effects observed, together with potential skin sensitization, should be considered as the most important hazard and a qualitative risk assessment performed for the local effects.
Long term exposure - systemic effects
Source study:
The 4-week oral repeat-dose toxicity study in rats was selected as the source study for DNEL derivation (Arrowsmith, 2003).
In this study, dose levels of 50, 150 or 1000 mg a.i./kg/day were administered by gavage to rats for 4 weeks. Following repeated dosing with the limit dose of 1000 mg a.i./kg/day, bodyweight gain was significantly reduced (-20% or -26%, for males or females, respectively), in association with lower mean food consumption (-14% or -11%, for males or females, respectively) and slightly lower efficiency of food utilisation, compared to respective controls. Minor changes occurred in clinical pathology parameters at 1000 mg a.i./kg/day. At necropsy, main observations consisted of inflammatory findings in the non-glandular region of the stomach and the mesenteric lymph nodes, which were attributed to the repeated gavage administration of a surfactant with irritating properties. These local toxicity findings were considered to be of limited relevance for the human situation, based on the route of administration, and the absence of any anatomical counterpart of the forestomach in the human species. The only other finding relevant to systemic toxicity at 1000 mg a.i./kg/day was a significantly lower mean absolute thymus weight compared to controls in males, correlating with a higher incidence of minimal thymic involution and atrophy at microscopic examination. These findings were observed in one gender only.
The dose of 150 mg a.i./kg/day was therefore considered as a NOAEL for systemic toxicity over 4 weeks of administration, and 1000 mg a.i./kg/day as a LOAEL for systemic toxicity, based on the amplitude and severity of the changes observed. These effects were considered to bear a threshold mode of action.
For oral route:
The oral route is considered not relevant to the worker situation.
For inhalation route:
- Modification of the starting point:
The starting point is converted using an oral-to-inhalation route extrapolation (assuming by default100% absorption for the inhalation and 50% absorption for oral exposure routes, and standard respiratory volumes of 0.38 m3/kg over 8 hours for rats, 6.7 m3/person over 8 hours and 10 m3/person over 24 hours for humans):
Inhalation NAEC worker (8 h)= 1000 x (1 / 0.38) x (50/100) x (6.7 / 10)= 881.6 mg/m3
- Assessment factors:
The following assessment factors were applied:
· Interspecies differences: not applicable (route-to-route extrapolation)
· Remaining interspecies TK differences (mainly toxicodynamic): 2.5 (default value)
· Intraspecies differences: 5 (default value for workers)
· Differences in duration of exposure: 6 (default value for subacute to chronic extrapolation)
· Issues related to severity and dose-response: 3 (because of the use of LOAEL as a starting point)
· Quality of whole database: 1 (reliability 1 study).
Global assessment factor= 2.5 x 5 x 6 x 3 x 1= 225
- DNEL:
Worker-DNEL long-term for inhalation route-systemic= 881.6 / 225= 3.9 mg/m3
For dermal route:
- Modification of the starting point:
The starting point (oral LOAEL) is not modified to take account of the ratio between oral absorption in rats and dermal absorption in humans, which are both considered equal to 100% by default, in a worst-case hypothesis.
Dermal LAEL worker=1000 mg/kg bw
- Assessment factors:
The following assessment factors were applied:
· Interspecies differences: 4 (default value for rats)
· Remaining interspecies TK differences (mainly toxicodynamic): 2.5 (default value)
· Intraspecies differences: 5 (default value for workers)
· Differences in duration of exposure: 6 (default value for subacute to chronic extrapolation)
· Issues related to severity and dose-response: 3 (because of the use of LOAEL as a starting point)
· Quality of whole database: 1 (reliability 1 study).
Global assessment factor= 4 x 2.5 x 5 x 6 x 3 x 1= 900
- DNEL:
Worker-DNEL long-term for dermal route-systemic= 1000 / 900= 1.1 mg/kg bw
Reference
· Arrowsmith W. DV6850 Toxicity study by oral administration to CD rats for 4 weeks. Huntingdon Life Sciences study report RHI 011/032437, 2003 (see section 7.5.1 of the IUCLID).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Given its oilfield application, no significant exposure of the general population to DV6850, directly or via the environment, is expected.
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.