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Diss Factsheets
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EC number: 263-580-6 | CAS number: 62518-65-4
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF Aktiengesellschaft, Experimentelle Toxikologie und Ökologie
- Limit test:
- no
Test material
- Reference substance name:
- 3-(m-tert-butylphenyl)-2-methylpropionaldehyde
- EC Number:
- 263-580-6
- EC Name:
- 3-(m-tert-butylphenyl)-2-methylpropionaldehyde
- Cas Number:
- 62518-65-4
- Molecular formula:
- C14H20O
- IUPAC Name:
- 3-(3-tert-butylphenyl)-2-methylpropanal
- Details on test material:
- - Name of test material (as cited in study report): m-Lysmeral
- Physical state: liquid/colorless, clear
- Analytical purity: > 98.4 %
- Lot/batch No.: 9336/08 S.50
- Storage condition of test material: Ambient (room temperature); under Argon
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Sulzfeld, Germany
- Age at study initiation: 33 +/-1 day
- Housing: 5 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light):12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The stability of the test substance in Olive Oil Ph. Eur at room temperature for a period of 7
days was proven with a comparable batch before the start of the administration period.
Homogeneity and concentration control analyses of the test-substance preparations were
performed in samples of all concentrations at the start of the administration period. - Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 150, 450
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily before and after the administration
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: prior to the administration period and thereafter at weekly intervals.
BODY WEIGHT: Yes
- Time schedule for examinations: During the administration period on day 0 (start of the administration period) and thereafter at weekly intervals.
FOOD CONSUMPTION:
- Food consumption for each animal determined : Yes, weekly over a period of 1 day and calculated as mean food consumption grams per animal and day.
FOOD EFFICIENCY:
Food efficiency (group means) was calculated based upon individual values for body weight and food consumption.
WATER CONSUMPTION : Yes
- Time schedule for examinations: weekly over a period of 4 days and calculated as mean water consumption in grams per animal and day.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: study day 29
- Anaesthetic used for blood collection: Yes (isoflurane)
- Animals fasted: Yes
- How many animals: all animals
- Parameters checked: Leukocyte/Erythrocyte/Platelet/Differential blood count, Hemoglobin, Hematocrit, Mean corpuscular volume, Mean corpuscular hemoglobin/concentration, Reticulocytes, Prothrombin time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: study day 29
- Animals fasted: Yes
- How many animals: all animals
- Parameters checked: Alanine aminotransferase, Aspartate aminotransferase, Alkaline phosphatase, gamma-Glutamyltransferase, Sodium, Potassium, Chloride, Inorganic phosphate, Calcium, Urea, Creatinine, Glucose, Total bilirubin, Total protein, Albumin, Globulins, Triglycerides, Cholesterol, Magnesium, Bile acids
URINALYSIS: Yes
- Time schedule for collection of urine: study day 27
- Metabolism cages used for collection of urine: Yes / No / No data
- Animals fasted: Yes
- Parameters checked: pH, Protein, Glucose, Ketones, Urobilinogen, Blirubin, Blood, Spec. Gravity, Sediment, Color, Turbidity, Volume
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: at the end of the administration period
- Dose groups that were examined: all animals
- Battery of functions tested: Home cage observations, Open field observations, Sensorimotor Tests/Reflexes, Motor activity assessment
OTHER:
Estrous stages: Vaginal smears for cycle determination were prepared in the morning of study termination and evaluated. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
ORGAN WEIGHTS: Yes
Liver; Kidneys; Adrenal glands; Testes; Epididymides; Cauda epididymides; Ovaries; Uterus; Spleen; Brain; Heart; Thymus; Thyroid glands (with parathyroid glands); Seminal vesicles including coagulation glands; Prostate
HISTOPATHOLOGY: Yes
All gross lesions; Liver, Spleen, Kidneys, Testes, Epididymides, Prostate, Seminal vesicle - Statistics:
- Clinical pathology parameters, urine volume, urine specific gravity, organ weights: KRUSKAL-WALLIS test (two-sided); WILCOXON test as post test
Urinalysis, except color, turbidity, volume and specific gravity: FISHER's exact test
Body weight, body weight change: DUNNETT's test (two-sided)
FOB (Feces, rearing, grip strength length forelimbs, grip strength length hindlimbs, footsplay test), motor activity : KRUSKAL-WALLIS test (two-sided); WILCOXON test as post test
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No animal died prematurely within the study.
Salivation (slight and moderate) before and after treatment :
450 mg/kg bw/d: 5/5 males, 5/5 females
150 mg/kg bw/d: 3/5 males, 5/5 females
Caused by a conditioning effect due to the daily gavage, assessed as not adverse. No other test substance related effects observed.
BODY WEIGHT AND WEIGHT GAIN
450 mg/kg bw/d: Statistically non-significant reduction in body weights/gain in males (96%/88% vs ctrl.) and females (96%/83 vs ctrl.).
No other substance-related effects observed
FOOD CONSUMPTION
No substance-related effects observed
FOOD EFFICIENCY
No substance-related effects observed
WATER CONSUMPTION
No substance-related effects observed
HAEMATOLOGY
No substance-related effects observed
CLINICAL CHEMISTRY
450 mg/kg bw/d - Males: decrease in Calcium, Total protein, Globulin, Total bilirubin, cholesterol; increase in Urea
450 mg/kg bw/d - Females:increase in trigycerides (within historical control range, regarded as non-adverse)
150 mg/kg bw/d - Males: decrease in Calcium, Total protein, Globulin, Total bilirubin; increase in Urea
50 mg/kg bw/d - Males: decrease in Total protein, Globulin (within historical control range, regarded as non-adverse)
No other substance-related effects observed
URINALYSIS
450 mg/kg bw/d - Males: higher incidences of crystals
450 mg/kg bw/d - Females: higher incidences of crystals, increase in protein
150 mg/kg bw/d - Males: higher incidences of crystals
150 mg/kg bw/d - Females: higher incidences of crystals
NEUROBEHAVIOUR
Functional observational battery (FOB): No substance-related effects observed
Motor activity measurement:
450 mg/kg bw/d: significantly decreased in males, caused by reduced motor activity within the first 30 minutes of measurement, which is the so called habituation phase.
ORGAN WEIGHTS (vs ctrl)
450 mg/kg bw/d:
Increase in liver weights: absolute male/ female (167%/143%), relative male/female (177%/153%);
Decrease in thymus weights: absolute male (80%)
150 mg/kg bw/d:
Increase in liver weights: absolute male/ female (141%/125%), relative male/female (138%/125%)
50 mg/kg bw/d:
Increase in liver weights: absolute male (113%); relative male (112%)
No other substance-related effects observed.
GROSS PATHOLOGY
450 mg/kg bw/d: enlarged livers (5/5 males; 5/5 females)
150 mg/kg bw/d: enlarged livers (2/5 females)
No other substance-related effects observed.
HISTOPATHOLOGY:
450 mg/kg bw/d: Liver (centrilobular hypertrophy of hepatocytes) in 5/5 males and 5/5 females
150 mg/kg bw/d: Liver (centrilobular hypertrophy of hepatocytes) in 2/5 females
No other substance-related effects observed.
OTHER FINDINGS:
Estrous stages: No substance-related effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: body weights, clincal chemistry/urinalysis
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
There was one male animal in the 450 and 150 mg/kg bw/day group each that exhibited a diffuse degeneration of seminiferous tubules in the testes and an oligospermia in the epididymides. These single cases are interpreted as spontaneous and incidental lesions,
which were not related to treatment. All other organs, including those of the male reproductive system, showed no lesions that could be related to treatment.
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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