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Diss Factsheets
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EC number: 200-580-7 | CAS number: 64-19-7
- 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:
- no hazard identified
- Most sensitive endpoint:
- irritation (respiratory tract)
- Route of original study:
- By inhalation
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- irritation (respiratory tract)
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 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:
- default AF; clear NOAEC
- AF for differences in duration of exposure:
- 1
- Justification:
- Local effect, not relevant
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA default – human data
- AF for other interspecies differences:
- 1
- Justification:
- This is consistent with local irritant property induced by an elevated concentration of a strongly acidic substance with little if any difference in toxicodynamic effect across species
- AF for intraspecies differences:
- 1
- Justification:
- This is consistent with local irritant property induced by an elevated concentration of a strongly acidic substance with little if any difference in toxicodynamic effect within species
- AF for the quality of the whole database:
- 1
- Justification:
- Default AF (human data available)
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: ECHA - substance specific AFs
- Overall assessment factor (AF):
- 1
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- Local effect, not relevant
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA default – human data
- AF for other interspecies differences:
- 1
- Justification:
- This is consistent with local irritant property induced by an elevated concentration of a strongly acidic substance with little if any difference in toxicodynamic effect within species
- AF for intraspecies differences:
- 1
- Justification:
- This is consistent with local irritant property induced by an elevated concentration of a strongly acidic substance with little if any difference in toxicodynamic effect within species
- AF for the quality of the whole database:
- 1
- Justification:
- Default AF (human data available)
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Workers - 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:
- 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
Since the initial REACH submission in November 2010, acetic acid has been considered by the Scientific Committee on Occupational Exposure Limits and concluded on an 8 hour OEL of 10 ppm (25 mg/m3) and STEL (15-min) of 20 ppm (50 mg/m3) (SCOEL/SUM/98; June 2012). This OEL is an agreement with the DNELl-t localproposed in the original REACH submission with rationale provided below. The proposed DNELacute local is amended to concur with the SCOEL recommendation.
The critical effect of occupational exposure to acetic acid is irritation of the skin and mucous membrane. There is reliable dose-response data on sensory irritation in human volunteers and this can be used to set limits for exposure. Minor subjective irritant effects have been reported in two volunteer studies at 10-ppm exposures (Ernstgård et al 2006, HVBG 2007). Although Ernstgård et al (2006) noted a nonsignificant increase in eye blink frequency at 10 ppm, this response was not observed in the larger study on volunteers observed over 4 hours and reported by HVBG (2007). Neither the Ernstgård nor the HVBG studies observed any physiological changes compatible with irritation at 10-ppm exposures. Ernstgård et al studied 11 volunteers in a 2-hour exposure and HVBG 24 subjects over 4 hours. The results reported in the two studies are comparable. Given the minor subjective effects reported at 10 ppm, the absence of any physiological measurements of irritation at this concentration, the possibility that smell may be affecting some self-reported ratings of irritation by the volunteers and a laterilisation (irritation) threshold of 40 ppm it is possible to recommend an 8-hour OEL of 10 ppm. Assuming 100 % respiratory uptake the inhaled dose over a working shift would be about 250 mg (25 mg/m3 x 10 m3). Given that the daily turnover of the acetate ion (the ionic form of acetic acid) is estimated to be about 45 g/day no systemic effects are expected at the proposed OEL. With an irritation (laterilisation) threshold identified at 40 ppm, it is unlikely that at exposures half of this there will be noticeable irritation over the short term and therefore a 20 ppm STEL can also be recommended.
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 (Appendix R.8-8). Acetic acid does not present an acute hazard (i.e. has no CLP classification) following ingestion, inhalation or skin contact. From the acute data it is possible to define a threshold for irritation to establish DN(M)ELs for local effects.
Local DNEL inhalation
Acute and long-term local DNEL inhalation values are based on human data reported by HVBG (2007) and Kleinbeck (2009)ith a NOAEC of 10 ppm (25 mg/m3). Discussion of selection of this endpoint for risk characterisation can be found in the irritation endpoint summary.Dose descriptor
For acute and repeat dose NOAEC – local effects – 10 ppm (25 mg/m3).
Acute and long term – local effects – DNELinhalation= 25 mg/m3
Systemic DNELs
It is not considered relevant to derive a systemic DNELinhal for acetic acid as the critical effects are local and a local DNELinhal of 10 ppm (25 mg/mg3) is proposed. This DNELinhal is considered protective for systemic effects i.e. systemic dose resulting from inhalation exposure that is tolerable in respect of local effects will always be negligible. The rationale for this is provided below: Considering systemic toxicity, there is no identified hazard as all effects are attributable to local effects at the site of entry (see repeat dose endpoint summary; section 5.5.4 above). Systemic exposure to acetic acid at exposure levels associated with the uses supported in this submission are insignificant compared with average daily intake. Following intake it has been shown that 120 mg/kg bw can be rapidly removed via the citric acid cycle (~0.5 mg/kg bw acetate removed per minute) in human subjects following administration of acetate in a drink (Smith et al., 2007), and daily administration of 40 mg/kg bw/day may be used as a medicinal product (Johnston & Gaas, 2006), and 25 mg/kg bw /day estimated as average human (infant) dietary intake (Ishiwata et al 2002), with peak excursions up to 240 mg/kg bw /day (EU DAR acetic acid, 2008). An atmospheric concentration of 10 ppm (25 mg/m3) acetic acid is the proposed NOAEC for local irritation effects. For worker systemic exposure at this concentration, for an 8 hour day spent at light work and assuming 100% absorption for a worker would be equivalent to a daily systemic dose of:
= 25 x wRVhuman(8h)
= 25 x 0.144
= 3.6 mg/kg bw per workday (8 h)
For the general population, systemic exposure at this concentration, for a 24 hour day and assuming 100% absorption would be equivalent to a daily systemic dose of:
= 25 x sRVhuman(24h)
= 25 x 0.288
= 7.2 mg/kg bw/d
Putting these values in perspective, they represent only a fraction of the total acetate which can be rapidly removed via the citric cycle each day and are low compared with human dietary intake.
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:
- DNEL (Derived No Effect Level)
- Value:
- 25 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:
- default AF; clear NOAEC
- AF for differences in duration of exposure:
- 1
- Justification:
- Local effect, not relevant
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA default – human data
- AF for other interspecies differences:
- 1
- Justification:
- This is consistent with local irritant property induced by an elevated concentration of a strongly acidic substance with little if any difference in toxicodynamic effect across species
- AF for intraspecies differences:
- 1
- Justification:
- This is consistent with local irritant property induced by an elevated concentration of a strongly acidic substance with little if any difference in toxicodynamic effect within species
- AF for the quality of the whole database:
- 1
- Justification:
- Default AF (human data available)
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- default AF; clear NOAEC
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Local effect, not relevant
- AF for other interspecies differences:
- 1
- Justification:
- ECHA default – human data
- AF for intraspecies differences:
- 1
- Justification:
- This is consistent with local irritant property induced by an elevated concentration of a strongly acidic substance with little if any difference in toxicodynamic effect within spec
- AF for the quality of the whole database:
- 1
- Justification:
- Default AF (human data available)
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncetainties
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:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- medium hazard (no threshold derived)
Additional information - General Population
See discussion above
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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