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EC number: 213-367-9 | CAS number: 939-97-9
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific principles.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- Principles of method if other than guideline:
- Testicular toxicity screening test: The test material was administered orally to 4 groups of rats at doses from 6.5 to 50 mg/kg bw for 5 consecutive days.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 4-tert-butylbenzaldehyde
- EC Number:
- 213-367-9
- EC Name:
- 4-tert-butylbenzaldehyde
- Cas Number:
- 939-97-9
- Molecular formula:
- C11H14O
- IUPAC Name:
- 4-tert-butylbenzaldehyde
- Details on test material:
- - Name of test material (as cited in study report): p-tert-butylbenzaldehyde
- Analytical purity: no data given
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: SPF albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 156-220 g
- Housing: two animals per cage during dosing period, after treatment in a metabolic cage for 24 h
- Diet: not specified, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-23 °C
- Humidity: 45-65 %
- Air changes: air-conditioned room
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: rape oil
- Details on exposure:
- Animals were randomly allocated to test groups by means of a random table.
The test material and the respective control was administered by gavage using a metal stomach tube once daily for 5 consecutive days at a dose volume of 10 ml/kg bw. - Details on mating procedure:
- only male rats were used
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 5 days
- Frequency of treatment:
- once daily
- Details on study schedule:
- only male animals were used and there was no mating
Doses / concentrations
- Remarks:
- Doses / Concentrations:
6.5, 12.5, 25 and 50 mg/kg bw/d
Basis:
nominal conc.
- No. of animals per sex per dose:
- test group: 8 males
control group: 4 males - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: 1 day
After the 5th treatment, urine was collected for 24 hours.
Examinations
- Parental animals: Observations and examinations:
- Mortality, clinical symptoms and body weight were observed and recorded daily during the treatment period and on the 6th test day.
- Oestrous cyclicity (parental animals):
- not applicable
- Sperm parameters (parental animals):
- not assessed
- Litter observations:
- not applicable
- Postmortem examinations (parental animals):
- Gross necropsy was performed after the 6th day on all rats. Liver, kidneys and testes were weighed. Liver/kidneys were fixed in 4% formol and embedded in PARAPLAST PLUS (no furhter assessment). Testes were fixed in mixture of Bouin, embedded in PARAPLAST PLUS, sectioned at a nominal thickness of 5µm and stained with haematoxylin/eosin
The testes of all rats were microscopically examined.
The condition of the seminiferous tubules was evaluated semiquantitative by examination/grading of 100 randomly selected, cross-sectioned tubules in a respective testis section. - Postmortem examinations (offspring):
- not applicable
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
All animals survived the experimental period. 3 rats treated with 12.5 mg/kg bw/d showed slight aggressiveness on test days 3 and 4. From days 3 to 6, a slight loss of hair was seen in one animal of the 50 mg/kg bw/d group.
Body weight development:
The test material did not affect the weight development of those animals treated with 6.5 and 12.5 mg/kg bw/d. Rats treated with 25 mg/kg bw/d initially showed a slight weight loss and returned to normal at the end of the treatment. The animals of the highest dose group had a severe weight loss throughout the study.
Necropsy and organ weights:
During the dissection, a marbled liver was recorded in 2 rats treated with 50 mg/kg bw/d. In one rat treated with 25 mg/kg bw/d a small dell was seen in the right kidney.
Testes weights of rats treated with 50 mg/kg bw/d were significantly lower than these recorded for the controls.
Histology:
The changes of testes caused by the treatment were circumscribed on the seminiferous epithelium. Interstitial cells and Sertoli cells were unaffected.
The following changes were seen: disorganisation of the epithelial structure, degeneration of cells, and reduction of the spermatozoa. A testis of a control rat showed about 80 % convoluted tubules with a normal epithelium (graduation 0) and about 20 % convoluted tubules with a normal epithelium but with degenerated cells or detritus in the lumina (graduation 1). This ratio occurred in the 6.5 and 12.5 mg/kg bw/d group, too. An alteration of this ratio was seen from the 25 mg/kg bw/d group on. Moderate to severe injuries were discovered in the seminiferous epithelia of all rats treated with 50 mg/kg bw/d.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 12.5 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- other: reduced mean weight of testes; changes of the seminiferous epithelium
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Table 1: Mean body weights (g) of the rats from day 1 to day
Dose (mg/kg bw) | day 1 | day 2 | day 3 | day 4 | day 5 | day 6 |
0 | 212 | 216 | 220 | 225 | 227 | 227 |
6.5 | 206 | 210 | 215 | 218 | 220 | 222 |
12.5 | 207 | 208 | 211 | 214 | 215 | 218 |
25 | 211 | 208 | 209 | 214 | 214 | 217 |
50 | 206 | 198 | 195 | 196 | 198 | 197 |
Table 2: Mean organ weights (g) of the rats
Dose (mg/kg bw/d) |
testis |
kidney |
liver |
0 |
2.576 ± 0.232 |
1.897 ± 0.113 |
10.69 ± 0.57 |
6.5 |
2.522 ± 0.101 |
1.974 ± 0.075 |
10.82 ± 0.49 |
12.5 |
2.570 ± 0.191 |
1.800 ± 0.152 |
10.34 ± 0.92 |
25 |
2.485 ± 0.203 |
1.807 ± 0.152 |
10.86 ± 0.76 |
50 |
2.206 ± 0.199 |
1.749 ± 0.076 |
10.11 ± 0.63 |
Concentration Grading mean %*
(mg/kg bw) 0 1 2 3
-------------------------------------------------------
control 78.1 21.9 0 0
6.5 82.5 17.5 0 0
12.5 83.0 17.0 0 0
25.0 53.6 34.6 5.7 6.1
50.0 1.5 27.6 43.8 27.1
-------------------------------------------------------
*examination/grading of 100 randomly selected, cross-sectioned tubules in a respective testis section.
Applicant's summary and conclusion
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