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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-564-8 | CAS number: 108-24-7
- 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:
- 4.2 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Inhalation route is directly applicable.
- AF for dose response relationship:
- 1
- Justification:
- ECETOC/ECHA default – clear NOAEC
- AF for differences in duration of exposure:
- 1
- Justification:
- Local effect, no need for adjustment for duration
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECETOC/ECHA default for inhalation route. No factor for allometric scaling is needed as local irritation effect, independent of basal metabolic rate.
- AF for other interspecies differences:
- 1
- Justification:
- Humans are not considered more sensitive than rats and an overall AF of 1 is considered appropriate
- AF for intraspecies differences:
- 1
- Justification:
- Reduced factor of 1 since the critical effect is a direct, local effect not influenced by toxicokinetics (due to physico-chemical properties of the substance).
- AF for the quality of the whole database:
- 1
- Justification:
- ECETOC/ECHA default; GLP-compliant guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- Local effect with clear NOAEC, no need for adjustment
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
- Most sensitive endpoint:
- irritation (respiratory tract)
- Route of original study:
- By inhalation
DNEL related information
- Justification:
- L
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.2 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: ECHA - substance specific AFs
- Overall assessment factor (AF):
- 1
- Dose descriptor:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- ECETOC/ECHA default – clear NOAEC
- AF for differences in duration of exposure:
- 1
- Justification:
- Local effect, no need for adjustment for duration
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECETOC/ECHA default for inhalation route. No factor for allometric scaling is needed as local irritation effect, independent of basal metabolic rate.
- AF for other interspecies differences:
- 1
- Justification:
- Humans are not considered more sensitive than rats and an overall AF of 1 is considered appropriate.
- AF for intraspecies differences:
- 1
- Justification:
- Reduced factor of 1 since the critical effect is a direct, local effect not influenced by toxicokinetics (due to physico-chemical properties of the substance).
- AF for the quality of the whole database:
- 1
- Justification:
- ECETOC/ECHA default; GLP-compliant guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 12.6 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- Overall assessment factor (AF):
- 1
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
An IOELV has not been established for acetic anhydride. Although some national OELs exist, for the purposes of this submission DNEL values are derived following the principles outlined in the relevant REACH guidance (Chapter R.8: Characterisation of dose [concentration]-response for human health).
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. Acetic anhydride does not present an acute hazard following ingestion or skin contact. It is, however, classified as harmful via inhalation exposure and therefore consideration of an acute DNELinhalation is required.
From the acute data available for acetic anhydride it is not possible to clearly define a threshold for irritation. However, from the 13-week study with a clear NOAEC at 1 ppm and limited histopathological findings restricted to the upper respiratory tract (nasal passages and larynx) at 5 ppm, the true threshold for irritation effects is between the two. In the same study significant recovery from irritation effects was reported in animals exposed to acetic anhydride for 13 weeks and then allowed a 13-week period without exposure.
In summary, it is proposed that 3 ppm would be protective for short term exposure (based on local effects):
DNELacute (inhalation) = 3 ppm (12.6 mg/m3)
Irritation
Acetic anhydride is classified as corrosive hence appropriate RMM and OCs should be employed.
For inhalation exposure, the acute DNELacute (inhalation) of 3 ppm is proposed for acetic anhydride and is considered to be protection for acute, local irritation effects.
DNELacute (local) = 3 ppm (12.6 mg/m3)
Long-term systemic effects
Dermal
Acetic anhydride is classified as corrosive hence appropriate RMM and OCs should be employed. No DNELl-t dermal is therefore appropriate.
Inhalation
Dose descriptor
The starting point of the NOAEC of 1 ppm (4.2 mg/m3) from the 90 day inhalation study will be used (HRC, 1996).
Considering exposure to acetic anhydride at an atmospheric concentration of 1 ppm (4.2 mg/m3), systemic exposure to acetate at this concentration is insignificant (see section 5.6.3 above). For an 8 hour day spent at light work, and assuming 100% absorption of acetic anhydride/acid for a worker would be:Systemic dose = 4.2 mg/m3* wRV m3/kg bw * [mw acetic anhydride / acetic acid]
= 4.2 * 0.144 * [102.09 / 60.05]
= 1.03 mg/kg bw.
To put this intake into perspective with the known removal of acetate, it has been shown that about ~0.5 mg/kg bw acetate can be removed each minute via endogenous pathways, such as the citric acid cycle, in humans following administration of acetate in a drink (Smith et al., 2007). Daily administration of 40 mg/kg bw/day may be used as a medicinal product (Johnston & Gaas, 2006), and 30 mg/kg bw /day is estimated as average human dietary intake (Ishiwata et al., 2002), with peak excursions up to 240 mg/kg bw /day (EU DAR, 2008).
Modification of dose descriptor
No modification is necessary.
According to the REACH guidance, time scaling is not appropriate when the toxic effect is mainly driven by the exposure concentration (as for irritation). Activity has marginal influence and thus there is no need for application of the 0.67 conversion factor to account for the difference between resting and light work respiratory volumes.
DNELl-t inhal = 1 ppm (4.2 mg/m3)
Long-term local effects
The
DNEL is derived for the critical effect of upper respiratory tract
irritation and therefore the DNELl-t
inhalation applies
DNELl-t
inhal (local) =
1 ppm (4.2 mg/m3)
Dermal
Acetic anhydride is classified as corrosive hence appropriate RMM and OCs should be employed.
No information is available to characterise the repeated local effects of acetic anhydride on the skin, while route-to-route extrapolation (respiratory tract to skin) is not appropriate.General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
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:
- no hazard identified
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
No consumer exposure anticipated therefore no DNELs proposed
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.
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