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EC number: 202-576-0 | CAS number: 97-36-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD and GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2',4'-dimethylacetoacetanilide
- EC Number:
- 202-576-0
- EC Name:
- 2',4'-dimethylacetoacetanilide
- Cas Number:
- 97-36-9
- Molecular formula:
- C12H15NO2
- IUPAC Name:
- 2',4'-dimethylacetoacetanilide
- Details on test material:
- - Name of test material (as cited in study report): Acetessig-m-Xylidid TF
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Hoechst AG, Kastengrund, SPF-breed
- Strain: Hoe: WISKf(SPF71)
- Age at start of study: approx. 6 weeks
- Housing: in air conditioned rooms in groups of 5
- Temperature: 22 +/- 3°C
- Rel. humidity: 50 +/- 20 %
- Artificial light: 12 hours daily
- Acclimatisation: min 5 days
- Diet: Altromin 1324 - rat diet, ad libitum, except when animals were housed in metabolism cage
- Water: tap water from plastic feeders, except when animals were housed in metabolism cage
- Labelling: Animals: numbered earmarks, Cages: numbered labels
- Randomization: yes
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: starch mash 2%
- Details on oral exposure:
- - Preparation of doses: daily, just before application
- Time of day of application: between 9.30 am and 12.00 am
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 applications in 29 days (7 times a week)
- Frequency of treatment:
- once a day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 8, 40, 200 mg/kg bw / day
Basis:
other: nominal
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- - General health status and behaviour twice a day during the week. During public holidays and weekends once a day
- Neurological status once a week
- Eyes, muscous membranes, dental status once a week
- Body weight: once immediately before start of the study, during the study twice a week
- Food consumption: twice a week
- Water consumption: once a week
- At the end of the study: hematology, clinical chemistry as well as urinalysis, organ weight, gross pathology, histological examination - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- parametric method by Dunnett, distributed-free methd by Nemenyi/Dunnett, two-sided T-test, two-sided Wilcoxen-test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- no macroscopic abnormalities
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 200 mg/kg group, male: decreased red blood cell count, hemoglobin, and hematocrit
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- 200 mg/kg group male and female: increased absolute and relative liver weight
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 200 mg/kg group male and female: pale kidneys
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 40 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Behaviour, common health state, food and water consumption and body weight gain were unaffected by the test substance.
200 mg/kg bw:
Haematology: Slight decrease of erythrocyte count, haemoglobin, and haematocrit
Dose (mg/kg bw) |
Erythrocytes |
Haemoglobin |
Heinz bodies |
|||
|
male |
female |
male |
female |
male |
female |
Control |
7.76 |
7.37 |
152 |
143 |
0.0 |
0.0 |
8.0 |
7.59 |
7.40 |
146 |
147 |
Not detected |
Not detected |
40.0 |
7.76 |
7.23 |
150 |
144 |
Not detected |
Not detected |
200.0 |
6.93 |
7.03 |
133 |
138 |
0.0 |
0.0 |
Clinical chemistry and urinalysis values were unaffected by the test substance.
Organ weight: Increased liver weight.
Gross pathology: Pale kidney
Histopathology: No abnormal findings
MetHb: No definite indications for MetHb formation reported. MetHb concentration not examined.
Applicant's summary and conclusion
- Conclusions:
- NOEL: 40 mg/kg bw
- Executive summary:
The test substance was tested for subacute oral toxicity in rats according to OECD 407. Following this guideline, doses of 0, 8, 40 or 200 mg/kg bw per day were administered. Examinations were done as follows: behaviour, general state of health, body weight, food and water consumption, hematology, clinical chemistry, urinalysis, gross pathology, absolute and relative organ weights, histopathology. Treatment related effects were seen as follows: 200 mg/kg group, male: decreased red blood cell count, hemoglobin, and hematocrit, male and female: increased absolute and relative liver weight, pale kidneys. No other substance related effects were observed. Based on these findings a NOEL of 40 mg/kg bw was derived.
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