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Diss Factsheets
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EC number: 252-813-7 | CAS number: 35948-25-5
- 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
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:
- 27.5 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):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 067 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- no inhalation toxicity data available
- AF for dose response relationship:
- 1
- Justification:
- default AF; clear NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- default AF for 90 day to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- inhalation, no allometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- default for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default AF for workers
- AF for the quality of the whole database:
- 3
- Justification:
- Single, non-GLP study, pre-dates OECD guidelines and has limitations in design and reporting
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 3.5 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):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 058 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- default AF; clear NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- default AF for 90 day to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- differences in metabolic rate (rat to human)
- AF for other interspecies differences:
- 2.5
- Justification:
- default for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default AF for workers
- AF for the quality of the whole database:
- 3
- Justification:
- Single, non-GLP study, pre-dates OECD guidelines and has limitations in design and reporting.
- AF for remaining uncertainties:
- 1
- Justification:
- non
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)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Acute toxicity
A DNEL for acute toxicity should be derived if an acute hazard leading to acute toxicity (e.g. C&L) has been identified and there is a potential for high peak exposures. These “peaks” are normally associated with inhalation exposure but are less common for skin contact and ingestion (TGD Guidance Appendix R.8-8). HCA is not classified for acute oral or dermal toxicity. No data are available for the inhalation route. No acute DNELs for systemic effects are required, but skin sensitisation is considered as HCA should be classified as a Category 1B sensitiser.
Local effects
Sensitisation
In case of skin sensitisation, the first step is a qualitative approach to assessing and controlling the risks, with information on the potency can be used in qualitative risk characterisation and for recommendation of appropriate RMMs and OCs. HCA should be classified as Category 1B sensitiser and therefore according to current guidance is ‘Moderate hazard’ (ECHA Guidance on information requirements and chemical safety assessment: Part E: Risk Characterisation; Version 2.0 November 2012) on the basis that exposure to these moderate skin sensitising substances should be well-controlled.
It is not possible to set a DNEL as no meaningful EC3 value can be derived (insufficient dose response date) from the available study (Török-Bathó, 2011).
Irritation
Corrosive and irritant effects on the skin and eye are local, concentration-dependent phenomena. No dose/response information can be derived from data available for HCA and DNELs cannot therefore be determined. HCA is not classified as a skin or eye irritant and is not corrosive.
Long-term systemic effects
The potential of a substance to cause long-term systemic effects can judged based on the results of repeated dose toxicity and reproductive (fertility, developmental) testing.
Oral:
sub-chronic effects: rat 16 wk NOAEL = 1058 mg/kg bw/d
It is clear that a systemic NOAEL (oral route) has been established as 1058 mg/kg bw/d (mean value for male and female rats) and this could be used to extrapolate a systemic DNEL following inhalation and dermal exposure.
Dermal
Dose descriptor
In sub-chronic studies the NOAEL for systemic effects was 1058 mg/kg bw/d in the rat and this value is used to derive the systemic DNEL long term for dermal exposure.
Modification of dose descriptor
Convert the rat oral NOAEL (mg/kg bw/d) into a human dermal NOAEL (mg/kg bw/d) after adjusting for differences in uptake between the two routes of exposure (TGD, Appendix R.8-2, Example B.5).
It is assumed that uptake of HCA after ingestion is 100% and after dermal exposure, is 100%.
correctedDermal NOAEL = NOAELoralx [ABSoral-rat/ABSdermal-human]
correctedDermal NOAEL = 1058 x [100/100] = 1058 mg/kg bwt/d
Assessment factors
Uncertainty |
ECHA AFs |
Justification |
Interspecies differences |
4 2.5 |
differences in metabolic rate remaining differences |
Intraspecies differences |
5 |
default AF for workers |
Differences in duration of exposure |
2 |
default AF for 90 day to chronic |
Dose response and endpoint specific/ severity issues |
1 |
default AF; clear NOAEL |
Quality of database |
3 |
Single, non-GLP study, pre-dates OECD guidelines and has limitations in design and reporting. |
Overall AF |
300 |
|
DNELl-t dermal = 1058 mg/kg bw/d / 300
= 3.5 mg/kg bw/d
Inhalation
Dose descriptor
In sub-chronic studies the NOAEL for systemic effects was 1058 mg/kg bw/d in the rat and this value is used to derive the systemic DNEL long term for inhalation exposure.
Modification of dose descriptor
Convert the rat oral NOAEL (mg/kg bw/d) into a human inhalation NOAEC (mg/m3) after adjusting for differences in uptake between the two routes of exposure (TGD, Appendix R.8-2, Example B.3).
It is assumed that uptake of HCA after ingestion is 100% and after inhalation exposure, is 100%.
NOAECinhalation =Oral NOAEL x [1/ sRVrat[1]] x [ABSoral-rat/ABSinhal-human] x [sRVhuman/wRV]
NOAECinhalation =1058 x [1/0.343] x [100/100] x [6.7/10]
= 2067 mg/m3
Assessment factors
Uncertainty |
ECHA AFs |
Justification |
Interspecies differences |
1 2.5 |
No difference in metabolic rate (inhalation) remaining differences |
Intraspecies differences |
5 |
default AF for workers |
Differences in duration of exposure |
2 |
default AF for 90 day to chronic |
Dose response and endpoint specific/ severity issues |
1 |
default AF; clear NOAEC |
Quality of database |
3 |
Single, non-GLP study, pre-dates OECD guidelines and has limitations in design and reporting. |
Overall AF |
75 |
|
DNELl-t inhal = 2067 mg/m3/ 75
= 27.5 mg/m3
Dermal & inhalation
No information is available to characterise the repeated local effects of HCA on the skin, while route-to-route extrapolation (respiratory tract to skin) is not appropriate.
[1] 8 hour value calculated from TGD Table R.8-17 values (as per guidance Appx R.8-2, example B.4) – sRV for rat (mean male/female) is 1.43 L/min/kg bw = 0.343 m3/kg bw for 8 hours (same duration of exposure as worker)
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
No exposure anticipated
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.