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EC number: 203-784-4 | CAS number: 110-62-3
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles (limited reporting)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 482 (Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells In Vitro)
- Deviations:
- yes
- Remarks:
- : limited reporting
- Principles of method if other than guideline:
- No guideline stated but the test method used is similar to OECD test guideline 482. Five n-alkanals were tested.
- GLP compliance:
- no
- Type of assay:
- DNA damage and repair assay, unscheduled DNA synthesis in mammalian cells in vitro
Test material
- Reference substance name:
- Valeraldehyde
- EC Number:
- 203-784-4
- EC Name:
- Valeraldehyde
- Cas Number:
- 110-62-3
- Molecular formula:
- C5H10O
- IUPAC Name:
- pentanal
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): pentanal (purchased from E. Merck, Darmstadt, Germany)
- Analytical purity: 98%
- no further information on test substance
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- hepatocytes: primary cultures from livers of two human subjects
- Details on mammalian cell type (if applicable):
- - primary human hepatocyte cultures were isolated from apparently healthy fragments of human livers obtained from one male and one femal human subject. Liver fragments were discarded during the course of prescribed surgery. As checked by both macroscopic and histological examinations, these fragments were devoid of appreciable alterations.
- primary hepatocytes were isolated by collagenase perfusion. The portion of viable cells was 65% and 83% respectively.
- Type and identity of media: Williams' medium E
- Test concentrations with justification for top dose:
- 0, 3, 10, and 30 mM (0, 0.26, 0.86, and 2.58 mg/mL); in addition 100 mM (8.61 mg/mL) for the determination of cytotoxicity
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: non
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-dimethylnitrosamine
- Remarks:
- Migrated to IUCLID6: concentration: 5 mM (0.37 mg/mL)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 20 h; cells were simultaneously exposed to test compound and tritiated thymidine (10 µCi/mL [methyl-3H]thymidine))
- Expression time (cells in growth medium): 20 h
- Fixation time (start of exposure up to fixation or harvest of cells): 20 h
STAIN (for cytogenetic assays): hematoxylin and eosin (after development of autoradiographs)
NUMBER OF REPLICATIONS: two cultures from distinct rats each
NUMBER OF CELLS EVALUATED: total of 200; 100 (2 slides) per culture
DETERMINATION OF CYTOTOXICITY
- Method: determination of viability (percent survival) by counting cells (1000/dish) after staining exposed cell cultures with 0.4% trypan blue - Evaluation criteria:
- A compound is considered positive if a dose-dependent increase is observed in net nuclear grains for at least two points and both increased points are above the justified laboratory-specific threshold, and/or statistical significance is demonstrated for both points (Internation Workshop on Standardization of Genotoxicity Test Procedures, Melbourne, 1992)
An absolute threshold for a positive response (i.e. 5 net nuclear grains) was not used. - Statistics:
- Statistical significance compared to controls was assessed by Student's t-test (two-tailed)
Results and discussion
Test results
- Species / strain:
- hepatocytes: primary cultures from livers of two human subjects
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Remarks:
- see table below
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- see table below
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Results of UDS test with primary human hepatocytes
Treatment |
Concentration [mg/mL] |
% Cell survival |
NUC* (mean ± SD) |
CYT* (mean ± SD) |
NNG* (mean ± SD) |
% Repair** |
|
Subject 1 |
Subject 2 |
||||||
Controls |
|
92 |
97 |
8.88 ± 3.36 |
8.33 ± 3.12 |
0.55 ± 1.69 |
1 |
Valeraldehyde |
0.26 |
91 |
95 |
10.01 ± 3.33 |
9.16 ± 2.40 |
0.85 ± 2.07 |
6 |
0.86 |
90 |
95 |
11.40 ± 4.21 |
10.54 ± 3.84 |
0.86 ±2.63 |
5 |
|
2.58 |
87 |
91 |
9.09 ± 5.12 |
8.00 ± 4.25 |
1.09 ± 3.02 |
8 |
|
DMNA**** |
0.37 |
80 |
93 |
24.64 ± 5.38 |
6.51 ± 3.94 |
18.13 ± 4.95*** |
90 |
* NUC: nuclear grain count; CYT: cytoplasmic grain count; NNG:net nuclear grains
** Percentage repair is the percentage of cells with net nuclear labeling ≥ 5 grains
*** p < 0.001
**** DMNA: N,N-Dimethylnitrosamine
No increase of net nuclear grains was observed in valeraldehyde treated cell cultures. The number of cells in repair was always below 10%.
Applicant's summary and conclusion
- Conclusions:
- In a UDS test similar to OECD test guideline 482, no increase in DNA repair could be observed after treatment of primary human hepatocytes with valeraldehyde. Valeraldehyde was demonstrated to be negative and not to induce a mutagenic response in primary human hepatocytes.
- Executive summary:
In an unscheduled DNA synthesis assay, primary cultures of human hepatocyte were exposed to valeraldehyde (purity 98%) at concentrations of 0, 0.26, 0.86, and 2.58 mg/ml for 20 h in the presence of tritium labeled thymidine. Human hepatocytes were obtained from discarded liver fragments during prescribed surgery of two human subjects.
Valeraldehyde was tested up to concentrations indicating the beginning of cytotoxicity. Treated cells did not show any statistically significant increases in DNA synthesis. The positive controls induced the appropriate response. There was no evidence that unscheduled DNA synthesis, as determined by radioactive tracer procedures (nuclear silver grain counts) was induced. Primary cultures of human hepatocytes were demonstrated to be negative in this unscheduled DNA synthesis assay (Martelli 1994).
This study is classified as acceptable. It satisfies the requirement of Test Guideline OECD 482 for DNA damage and repair (deviation: limited reporting).
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