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EC number: 202-601-5 | CAS number: 97-67-6
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Final Report on the Safety Assessment of Malic Acid and Sodium Malate
- Author:
- Fiume MZ, Bergfeld WF, Belsito DV, Klaassen CD, Schroeter AL, Shank RC, Slaga TJ, Snyder PW, and Andersen FA
- Year:
- 2 001
- Bibliographic source:
- Int J Toxicol 20 (Suppl 1): 47-55
Materials and methods
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- L-malic acid
- EC Number:
- 202-601-5
- EC Name:
- L-malic acid
- Cas Number:
- 97-67-6
- Molecular formula:
- C4H6O5
- IUPAC Name:
- malic acid
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Remarks:
- weanling albino rats
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 9 wks prior to mating for the F1A litter, through weaning of the F1B litter
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 ppm
- Dose / conc.:
- 10 000 ppm
- No. of animals per sex per dose:
- 10 males, 20 females
- Control animals:
- yes, sham-exposed
- Details on study design:
- The F1A litters were culled to a maximum of eight pups, reproductive indices were monitored, and after 21 days, approximately one-third of the pups were
necropsied. One wk after weaning of the last F1A litter, the P1 parents were remated to produce the F1B litter, which was also culled and monitored.
After 21 days, 10 male and 20 female weanlings from each group were selected for the P2 generation. Approximately one-third of the remaining pups were nacropsied. The P2 generation was fed the appropriate diet and mated when the animals reached approximately 100 days of age to produce the F2A generation, and the same procedures were followed as above. One-half of the F2B litters were delivered naturally end held until weaning, while the other half were delivered
by Caesarean section on day 19 of gestation.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Appearance and behavior were similar for P1 test and control rats.
- Mortality:
- no mortality observed
- Description (incidence):
- Survival was similar for test and control animals. None of the P1 animals died during the F1A or F1B phase.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Prior to mating of the P1 generation, body weight gains of males of the test groups were slightly decreased compared to control animals; female body weights were comparable.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Feed consumption was similar for test and control animals.
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- Behavior was similar for P1 test and control rats.
Reproductive function / performance (P0)
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- For all litters, the various indices, litter sizes, and pup body weights were comparable among test and control animals.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 10 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: no effects at the highest dose level tested
Results: P1 (second parental generation)
General toxicity (P1)
- Description (incidence and severity):
- The P2 test and control animals were similar throughout the study; wheezing was observed in all groups during the F2B phase.
Results: F1 generation
General toxicity (F1)
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In the F1A litters, all of the necropsied pups In three of the low-dose litters had rough surfaces on the spleen.
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- In the F2A litters, the number of pups that were weak or had labored respiration during lactation was increased in the high-dose group.
In the F2B litters, weakness and labored respiration were reported for a few low-dose pups. - Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In the F2A litters, renal discoloration (two animals), dark renal medullas (four animals), rough surfaces on the spleen (four animals), and white loci on the spleen (three animals) were found in Iow-dose weanling animals and renal discoloration (three animals), dark red corticomedullary zones (three animals), dark renal medullas (three animals), rough surfaces on the spleen (two animals), and a firm, enlarged, irregularly-shaped cecum with a hole penetrating it (one animal) were found in high-dose weanling animals at necropsy.
In the F2B litters, weakness and labored respiration were reported for a few low-dose pups, and the renal pelvis of one high-dose pup was dilated at necropsy.
Details on results (F2)
Applicant's summary and conclusion
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