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Diss Factsheets
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EC number: 201-289-8 | CAS number: 80-54-6
- 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://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- repeated dose toxicity: dermal
- Remarks:
- other: Subacute - 5 day repeated dose application
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Screening study with main focus on male reproductive organs. Meets basic scientific principles with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
- Principles of method if other than guideline:
- Groups of 5 Fu male albino rats/dose received occluded applications of pure test material 6 h/day for 5 consecutive days. Observations conducted included mortality, body weight, general symptoms, necropsy and microscopic examination of the testes and epididymides. Sacrifice was day 7
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-(4-tert-butylbenzyl)propionaldehyde
- EC Number:
- 201-289-8
- EC Name:
- 2-(4-tert-butylbenzyl)propionaldehyde
- Cas Number:
- 80-54-6
- Molecular formula:
- C14H20O
- IUPAC Name:
- 3-(4-tert-butylphenyl)-2-methylpropanal
- Details on test material:
- - Source: Givaudan Vernier
- Analytical purity: 99.1%
- Physical state and appearance: liquid, colourless to pale yellow
- Stability: 1 yr (in container)
- Batch: 180949
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Fuellinsdorf albino (also known as ibm:RORO (SPF))
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Biological Research Laboratories Ltd., Füllinsdorf, Switzerland
- Housing: 1 animal/cage
- Age at study initiation: male, 8 weeks
- Weight at study initiation: 216.5 g
- Diet: ad libitum (Kliba maintenance diet No 343 (pellet), defined and certified for acceptable contaminant
- Water: ad libitum (tap water)
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Application site: back
- Area of exposure: 10 % of total body surface area
- After application the dressing was wraped around the abdomen and fixed with an elastic adhesive bandage
- Duration of treatement: 6h
REMOVAL OF TEST SUBSTANCE
- Washing: Yes, with absolute ethyl alcohol and warm water
- Time after start of exposure: 6h
TEST MATERIAL
- Amount(s) applied: no data
- Concentration (if solution): undiluted - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 5 days
- Frequency of treatment:
- Once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
250; 500; 1000; 2000 mg/kg
Basis:
other: nominal
- No. of animals per sex per dose:
- 5 male animals
- Control animals:
- no
- Details on study design:
- - Justification for choice of animals: The authors stated that rats are a species acceptable by regulatory authorities with documented susceptibility to a wide range of toxic substances. Futhermore, historical data was available to the authors from studies performed in the same labs using this strain. In addition, there were adequate references in the scientific literature to assist in the assessment of the changes observed in the treated animals
The 1st treatment day was defined as day 0, week 0. The 2nd treatment day was defined as day 1, week 1. The 1st treatment week started on day 1 and terminated on day 5. After dosing, the animals were observed for another 2 days before sacrifice.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: days 0, 1, 2, 3, 4, 7
- Cage side observations checked included: behaviour, vivacity, signs of injury, signs of sickness and abnormality. All lesions or symptoms deviating from normal were recorded for each individual rat
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
MORTALITY: Yes
- Check conducted continuously
BODY WEIGHT: Yes
- Time schedule for examinations: days 0, 1, 2, 3, 4, 7
HISTOPATHOLOGY
- Organs examined: testes, epididymides, gross lesions, examined microscopically - Sacrifice and pathology:
- SACRIFICE
- Schedule: at termination (day 7)
- Fasting before sacrifice: Yes, overnight
- Number of animals: all survivors
- Method: exsanguination after CO2 narcosis, incision of the aorta
GROSS PATHOLOGY: Yes
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
- No symptoms were observed during the course of the study
BODY WEIGHT AND WEIGHT GAIN
- Control; 250; 500; 1000 mg/kg: body weight increased steadily during throughout the study
- 2000 mg/kg: Mean body weight was depressed immediately after first administration. Maximum decrease observed was 2% compared to day 0 . The animals of this group did not regain the pretreatment weight until after the application of the last dose.
GROSS PATHOLOGY
- No substance related necropsy findings
HISTOPATHOLOGY:
- 2000 mg/kg: marked atrophy of testes
Seminiferous tubules with disorganization of the epithelial structure, decrease of the number of germ cells, increase of the number of degenerating germ cells (inclusive giant cells) were observed in combination with immature/degenerating germ cells in epididymides and the occurrence of spermatocele.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: testes with additional systemic toxicity
Target system / organ toxicity
- Critical effects observed:
- not specified
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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