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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 12 1995 to Feb 7 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report. No restrictions, fully adequate for assessment.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 413
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Acetic anhydride
- EC Number:
- 203-564-8
- EC Name:
- Acetic anhydride
- Cas Number:
- 108-24-7
- Molecular formula:
- C4H6O3
- IUPAC Name:
- acetyl acetate
- Details on test material:
- - Name of test material (as cited in study report): acetic anhydride
- Physical state: liquid
- Analytical purity: 99% +
- Purity test date: Responsibility of sponsor
- Lot/batch No.: 50218009
- Expiration date of the lot/batch: Responsibilty of Sponsor
- Storage condition of test material: Ambient temperature, dry.
Constituent 1
Test animals / tissue source
- Species:
- rat
- Strain:
- other: CD (Sprague Dawley)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Manston Rd, Margate, Kent, UK.
- Age at study initiation: 7-8 wks at randomisation
- Weight at study initiation: 227g (males), 184 g (females)
- Age at start of exposures: 10-11 wks
- Housing: 5/cage (same sex) in suspended stainless steel cages with wire mesh front, back and floor and stainless steel sheet sides.
- Diet (e.g. ad libitum): SDS Rat & Mouse no. 1 SQC modified maintenance diet, Special Diet Services, Witham, Essex, UK.
- Water (e.g. ad libitum): Tap water provided in ploypropylene bottles
- Acclimation period: 4 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 ºC
- Humidity (%): 40-65 %
- Air changes (per hr): No details. Cages for each test group kept in separate ventilated cabinets.
- Photoperiod (hrs dark / hrs light): 12/12 (0730-1930)
IN-LIFE DATES: From: 12 July 1995 To: 7 February 1996
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 1, 5, 20 ppm Target concentration
0.98, 4.96, 20.0 ppm Analytical concentration
1.23, 6.5, 26.3 ppm Nominal concentration - Duration of treatment / exposure:
- 6 hrs/day, 5 days/week for 13 weeks
- Observation period (in vivo):
- 13 weeks treatment; 13 weeks post-exposure
- Number of animals or in vitro replicates:
- 15/sex/group (including 5/sex/group for withdrawal period)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Ocular changes were described as part of the clinical observations.
- Time point:
- other: At least once daily.
- Remarks on result:
- other: score not provided
- Irritation parameter:
- other: Ophthalmic examination by indirect ophthalmoscope.
- Time point:
- other: All animals pre-study, all main study animals in week 13, all withdrawal animals in week 26.
- Remarks on result:
- other: Prior to examination, pupils were dilated using 0.5% Mydriacyl.
- Irritation parameter:
- cornea opacity score
- Remarks:
- Not measured
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Remarks:
- Not measured
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Remarks:
- Not measured
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Remarks:
- Not measured
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Partially closed eyes were observed during the first two expsoures in high dose animals.
During week 13, corneal changes were evident in a number of animals in the intermediate and high doses groups and comprised corneal lack-lustre and corneal opacities (bi-lateral in less than half of the cases). There were no treatment related findings in week 26.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Clinical signs and ophthalmoscopy
- Conclusions:
- In the presence of acetic anhydride vapour, reversible ocular irritation with mild corneal effects were reported.
- Executive summary:
Following whole-body inhalation exposure to 0, 1, 5 or 20 ppm acetic anhydride for 6hr/day for 13 weeks, signs of eye irritation were seen in 20 ppm animals during the first two exposures only.
Corneal lesions were observed in most animals exposed to 20 ppm and in a few exposed to 5 ppm after 13 weeks of exposure. These findings were consistent with exposure to an irritant or mildly corrosive atmosphere and were not observed histologically. There were no treatment related changes after 13 weeks of withdrawal.
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