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EC number: 205-089-1 | CAS number: 133-08-4
- 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
Endpoint summary
Administrative data
Description of key information
There is no data available for diethyl butylmalonate (CAS # 133 -08 -4). For C&L purposes, the following data available for structurally similar substances cited in the 2006 OECD SIDS “malonic acid diesters” (UNEP Publications, Final 10/2006) is suitable for read across:
Dimethylmalonate, CAS # 108-59-8
OECD 422 NOAEL = 300 mg/kg
Diethylmalonate, CAS # 105-53-3
Limited study with NOAEL in the only dose level tested
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
There is no data available for diethyl butylmalonate (CAS # 133 -08 -4). For C&L purposes, the following data available for structurally similar substances cited in the 2006 OECD SIDS “malonic acid diesters” (UNEP Publications, Final 10/2006) is suitable for read across:
Dimethylmalonate, CAS # 108-59-8
In a subacute combined repeated dose reproductionl/developmental screening test with DMM
according to OECD TG 422 and GLP, groups of 10 male and female Wistar rats received doses of
100, 300 and 1000 mg/kg bw per day by gavage once daily, 7 d per week. A high dose recovery and
recovery control group of 5 animals of each sex per group was also included in the study. Males
received the test item 2 weeks prior to mating, during the mating period and approximately 2 weeks
post mating, with a total of 39 treatment days. Females were treated 2 weeks prior to mating, during
the mating period, throughout pregnancy and up to lactation day 4. Recovery animals were treated
for 39 days followed by a post exposure observation period of 14 days. The animals were examined
daily for clinical signs and a FOB was performed in randomly selected 5 males and females of each
group at the end of the dosing period for males and during the lactation period for females. Body
weights were recorded at the beginning of the study, at last weekly thereafter and at termination. All
dams were weighed on gestation days 0, 7, 14, and 20 and lactation days 1 and 4. Food consumption
was recorded weekly. Standard hematology and clinical chemistry parameters were
determined in 5 randomly selected males and females of each group at the end of the premating
period and the recovery period respectively. Organ weights of liver, adrenals, kidneys, thymus,
spleen, brain, and heart were determined of 5 males and females of each group. Testes and
epididymis weights were determined of all adult males of each group. All adult animals and pups
were examined for any structural abnormalities and pathological changes. Standard histopathology
was performed on all major tissues of 5 males and 5 females of the control and high dose groups as
weIl as all animals of the recovery and recovery control groups. Livers and testes of 5 males and
females in the low and mid dose groups were also examined histopathologically. Stages of
spermatogenesis and interstitial testicular structure were determined additionally.
No treatment related effects were observed on clinical symptoms, performance in the FOB, body
weight and body weight gain, food consumption, clinical chemistry, hematology, organ weights or
gross pathology. In the histopathological examination livers of animals of both sexes in the high
dose group showed a significantly increased incidence of hepatocellular hypertrophy. Similar
changes were not observed in the high dose recovery group indicating reversibility of the effect. At
dose levels of 300 and 100 mg/kg bw per day no treatment related histopathological changes were
observed. The NOAEL for repeated dose toxicity is therefore 300 mg/kg bw (OECD SIDS, 2006)
Diethylmalonate, CAS # 105 -53 -3
For DEM a limited subchronic toxicity study was reported in the literature. Ten to 16 male and
female CD-rats received DEM in their diet for 90 days at dose leveis of 36 mg/kg bw per day for
males and 41 mg/kg bw per day for females. A comparable untreated group of rats served as
control. Details of the study were not reported. The authors report that no treatment related
differences were found between the two groups with regard to growth, food intake, hematological
and clinical chemistry parameters, blood-urea levels, organ weights and organ pathology
(Posternak, Lindner, and Vodoz, 1969 cited in OECD SIDS, 2006).
Justification for classification or non-classification
Based on the available data for read across substances Dimethylmalonate, CAS # 108-59-8 and Diethylmalonate, CAS # 105 -53 -3, there is no indication that Diethyl butylmalonate (CAS # 133 -08 -4) would require classification for repeated dose toxicity.
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