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EC number: 208-798-4 | CAS number: 542-08-5
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study is judged with reliability 1 even if not all information can be provided in the RSS. This is due to a two paged summary of the study provided by the study owner that did not contain all information needed to complete the RSS but a statement that the study is reliable without restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Isopropyl acetoacetate
- EC Number:
- 208-798-4
- EC Name:
- Isopropyl acetoacetate
- Cas Number:
- 542-08-5
- Molecular formula:
- C7H12O3
- IUPAC Name:
- propan-2-yl 3-oxobutanoate
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- Information not provided in LoA data.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 12.5, 25, 50, 100 %
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
For determination of the highest non-irritant and technically applicable test item concentration, a non-GLP pretest was performed on two mice with concentrations of 6.25, 12.5, 25, 50, and 100 % (w/v).
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentrations resulted in 3-fold or greater increase in incorporation of 3HTdR compared to the concurrent control, as indicated by the stimulation index. The estimated concentration of test item required to produce an S.I. of 3 is referred to as the EC3 value.
TREATMENT PREPARATION AND ADMINISTRATION:
Four female mice were treated with different concentrations of the test item and vehicle alone by topical application at the dorsum of each ear lobe (left and right) on three consecutive days. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a beta-scintillation counter. - Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- Information not provided in LoA data.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.36
- Test group / Remarks:
- 100 %
- Parameter:
- SI
- Value:
- 0.48
- Test group / Remarks:
- 50 %
- Parameter:
- SI
- Value:
- 0.76
- Test group / Remarks:
- 25 %
- Parameter:
- SI
- Value:
- 1.62
- Test group / Remarks:
- 12.5 %
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
:
The proliferative response of lymph node cells is expressed as the number of radioactive disintegrations per minute per lymph node and as the ratio of 3HTdR incorporated into lymph node cells of test lymph nodes relative to that recorded for control lymph nodes (stimulation index).
In this study stimulation indices of 1.62, 0.76, 0.48, and 0.36 were determined with the test item at concentrations of 12.5, 25, 50, and 100 % (w/v) in vehicle, respectively.
EC3 CALCULATION :
In this study the EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.
CLINICAL OBSERVATIONS:
No deaths occurred during the study period. No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
BODY WEIGHTS:
The body weights of the animals, recorded prior to the 1st application and prior to necropsy was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was determined to have no skin sensitising potential.
- Executive summary:
Four female mice were treated with the test item at concentrations of 12.5, 25, 50 and 10 % (w/v) in a study according to OECD guideline 429. The test item was applied on the ears of the animals on three consecutive days. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of3H-methyl thymidine measured in a β-scintillation counter. No deaths occurred, no symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. The body weights of the animals were within the range commonly recorded for animals of this strain and age. Stimulation indices of 1.62, 0.76, 0.48, and 0.36 were determined with the test item at concentrations of 12.5, 25, 50, and 100 % (w/v) in vehicle, respectively. Therefore, the test item was found to be not a skin sensitiser.
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