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EC number: 200-473-5 | CAS number: 60-35-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-12-10 -
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Data obtained from a guideline study according to the OECD Guideline 437 and therefore considered reliable without restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- yes
- Remarks:
- The measurement of the opacity was performed with a photometer (570 nm) in-stead of an opacitometer. This can be seen as uncritical, because the opacity can be calculated from the absorption
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Acetamide
- EC Number:
- 200-473-5
- EC Name:
- Acetamide
- Cas Number:
- 60-35-5
- Molecular formula:
- C2H5NO
- IUPAC Name:
- acetamide
- Test material form:
- solid: crystalline
- Details on test material:
- Name Acetamid
Appearance colorless crystal substance
CAS No. 60-35-5
EINECS-No. 200-473-5
Molecular formula C2H5NO
Molecular weight 59.07 g/mol
Purity content > 99 %
Constituent 1
Test animals / tissue source
- Species:
- other: not applicable, in vitro
- Strain:
- other: not applicable, in vitro
- Details on test animals or tissues and environmental conditions:
- not applicable, in vitro
Test system
- Vehicle:
- other: suspension with a concentration of 20 % in 0.9 % sodium chloride solution
- Controls:
- other: not applicable, in vitro
- Amount / concentration applied:
- 750 µL of the test item were tested as suspension at 20% concentration in 0.9% sodium chloride solution.
- Duration of treatment / exposure:
- Exposition time on the corneas was 4 h ± 5 min.
- Observation period (in vivo):
- 330 min
- Number of animals or in vitro replicates:
- not applicable, in vitro
Results and discussion
In vivo
Results
- Irritation parameter:
- other: In Vitro Irritancy Score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- > 55
- Max. score:
- 0.951
- Reversibility:
- not specified
Any other information on results incl. tables
Absorbance and Opacity Values Negative Control
Parameter |
Negative Control |
||
Absorbance before exposition |
0.1690 |
0.1633 |
0.1622 |
Absorbance after exposition |
0.2277 |
0.2201 |
0.2861 |
Opacity before exposition |
1.4757 |
1.4565 |
1.4528 |
Opacity after exposition |
1.6893 |
1.6600 |
1.9324 |
Opacity Difference |
0.2136 |
0.2035 |
0.4796 |
Absorbance and Opacity Values Test Item and Positive Control
Parameter |
Test ItemAcetamid |
Positive Control |
||||
Absorbance before exposition |
0.2165 |
0.1200 |
0.1957 |
0.1634 |
0.2081 |
0.1341 |
Absorbance after exposition |
0.2603 |
0.4343 |
0.4815 |
1.8171 |
1.8312 |
1.7969 |
Opacity before exposition |
1.6463 |
1.3183 |
1.5693 |
1.4568 |
1.6147 |
1.3618 |
Opacity |
1.8210 |
2.7183 |
3.0304 |
65.6296 |
67.7954 |
62.6470 |
Opacity |
0.1747 |
1.4001 |
1.4611 |
64.1728 |
66.1806 |
61.2852 |
IVIS
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
0.791 |
0.679 |
27.2 % |
0.466 |
|||
0.780 |
|||
Test Item |
- 0.129 |
0.951 |
103.6 % |
1.802 |
|||
1.180 |
|||
Positive Control |
74.8 |
77.4 |
2.9 % |
78.3 |
|||
79.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item Acetamid showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.951. According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
- Executive summary:
The eye irritative properties of Acetamide were evaluated in the BCOP Test following OECD Guideline 437 resp. EU Method B.47. Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old.
The test itemAcetamidwas brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for one hour and whose opacity had been measured. The test item was incubated on the cornea for4 hours at32 ± 1 °C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured.
Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea.
20 % imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea.
The test itemAcetamidshowed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.951.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
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