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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 816-455-0 | CAS number: 960253-23-0
- 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:
- 9.87 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 493 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 4
- Justification:
- An assessment factor of 6 applies to extrapolation from sub-acute 28-day exposure to chronic exposure, and an assessment factor of 2 applies to extrapolation from sub-chronic 90-day exposure to chronic exposure. The OECD 421 has an exposure period of ~63 days, which is approximately intermediate between 28 and 90, so it is appropriate and justifiable to use an intermediate assessment factor of 4.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- According to ECHA Guidance (default)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 45.01 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 37.5
- Dose descriptor starting point:
- NOAEC
- Value:
- 1 000 mg/m³
- Modified dose descriptor starting point:
- other: Time scaled (Haber's law) LC50 and modified for respiratory volumes (workers)
- Value:
- 1 688 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There is a GLP OECD 403 (acute toxicity study by inhalation) that is available on Scentaurus clean and that lead to the classification of the substance as Acute Tox. category 4. In this study, rats where exposed for 4 hours to an aerolsolized dose of Scentaurus clean.
In the first group of 10 rats (5 males and 5 females) that was dosed at 5mg/L, 1 male was found dead following exposure to the substance and 3 males and 1 female showing signs of severe toxicity had to be euthanised for humane reasons in the following days after exposure. Several other obvious signs of severe toxicity were observed (lethargy, hunched posture, slow breathing, labored respiration, rales, piloerection and ptosis, bodyweight loss, abnormalities in the sacrificed animals in the lungs (pale with many dark red or black), stomach and intestines (distended with gas) and thymus (many dark red foci)). As such, the LC50 is concluded to be below or equal to 5mg/L for Scentaurus clean. However, as this study is based on current standard protocols, the mortalities observed are related to evident or severe toxicity signs and not typical mortality (only one animal was found dead and the other four were euthanised). The dose of 5mg/L can thus be considered to be more of a severe LOAEC (ECHA Guidance R.8, APPENDIX R. 8-8).
In the second group that was dosed as a follow up, no mortalities and no signs of toxicity were observed. Only slight clinical signs remained (hunched posture and rales) which could be attributed to the unpleasant taste and smell to the rat of the fragrance substance Scentaurus clean, as was also observed in the available OECD 422 by gavage. As this dose showed no signs of sub-lethal toxic effects, it is considered to be the NOAEC for acute systemic toxicity and it is further used as starting point to derive the DNELacute inhalation for workers.
In accordance with APPENDIX R. 8-8 Acute toxicity of the ECHA Guidance R.8, the starting point of 1mg/L is further modified for time-scaling following Haber's law to convert a 4hr experimental exposure into a 15 minutes daily exposure duration for workers.
NOAECTime-scaled = ∛[NOAECacute 4hr× 240 (minutes)/15 (minutes)] = ∛[1000× 240/15] = 2520 mg/m3
It is then adjusted for differences in respiratory volumes to account for the light activity in workers compared to the resting condition of the experimental animals.
NOAECTime-scaled & modified=NOAECTime-scaled× (exp. cond. rat)/(exp. cond. human)=2520 mg/m3× (6,7 m3)/(10m3) = 1688mg/m3
- AF for dose response relationship:
- 3
- Justification:
- Although the starting dose can be considered to be a NOAEL, a conservative approach is taken and the minimal AF of 3 usually applied for using LOAEL is used to account for the remaining slight clinical signs observed and potential sub-lethal effects that could have been overlooked in the design of the acute toxicity study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- According to ECHA Guidance (default)
- AF for other interspecies differences:
- 2.5
- Justification:
- According to ECHA Guidance (default)
- AF for intraspecies differences:
- 5
- Justification:
- According to ECHA Guidance (default)
- AF for the quality of the whole database:
- 1
- Justification:
- Based on GLP and OECD guideline studies, with correlated observations within the dataset, especially between the acute inhalation study in rat (OECD 403) and the combined oral 28d and reproductive/developmental toxicity study (OECD 422)
- AF for remaining uncertainties:
- 1
- Justification:
- No further AF is considered needed. Moreover, as the Vapour Pressure of the substance is very low, peak exposure in the magnitude of the one generated in the OECD 403 is highly unlikely in any of the expected exposure scenarios. Additionally, only an overall very low systemic toxicity potential is demonstrated in the OECD 422 and OECD 403.
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:
- 2.8 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 560 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 4
- Justification:
- An assessment factor of 6 applies to extrapolation from sub-acute 28-day exposure to chronic exposure, and an assessment factor of 2 applies to extrapolation from sub-chronic 90-day exposure to chronic exposure. The OECD 421 has an exposure period of ~63 days, which is approximately intermediate between 28 and 90, so it is appropriate and justifiable to use an intermediate assessment factor of 4.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- According to ECHA Guidance (default)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.74 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 174 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 4
- Justification:
- An assessment factor of 6 applies to extrapolation from sub-acute 28-day exposure to chronic exposure, and an assessment factor of 2 applies to extrapolation from sub-chronic 90-day exposure to chronic exposure. The OECD 421 has an exposure period of ~63 days, which is approximately intermediate between 28 and 90, so it is appropriate and justifiable to use an intermediate assessment factor of 4.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- According to ECHA Guidance (default)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 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):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 4
- Justification:
- An assessment factor of 6 applies to extrapolation from sub-acute 28-day exposure to chronic exposure, and an assessment factor of 2 applies to extrapolation from sub-chronic 90-day exposure to chronic exposure. The OECD 421 has an exposure period of ~63 days, which is approximately intermediate between 28 and 90, so it is appropriate and justifiable to use an intermediate assessment factor of 4.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- According to ECHA Guidance (default)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- 1 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):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 4
- Justification:
- An assessment factor of 6 applies to extrapolation from sub-acute 28-day exposure to chronic exposure, and an assessment factor of 2 applies to extrapolation from sub-chronic 90-day exposure to chronic exposure. The OECD 421 has an exposure period of ~63 days, which is approximately intermediate between 28 and 90, so it is appropriate and justifiable to use an intermediate assessment factor of 4.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- According to ECHA Guidance (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
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.