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EC number: 203-419-9 | CAS number: 106-65-0
- 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
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Link to relevant study records
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Dimethyl succinate is metabolised by hydrolysis to form the corresponding dicarboxylic acid (succinic acid) and methanol. Succinic acid is an endogenous metabolite in the body and is a component of the Krebs cycle (Voet, D. & Voet, J.G., eds. (1990) Biochemistry, New York: John Wiley & Sons, pp. 506-527, 632-633, 690). Data on methanol are presented.
2. SOURCE AND TARGET CHEMICAL(S)
The source substance is a metabolite of the target substance. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Deviations:
- yes
- Remarks:
- data documentation limited; extended copulation time (21 days); not all parameters mentioned in the guideline were investigated
- Species:
- rat
- Strain:
- Sprague-Dawley
- Body weight and weight changes:
- no effects observed
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 1.3 mg/L air (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Lack of effect on reproductive parameters
- Key result
- Critical effects observed:
- no
- Dose descriptor:
- NOAEC
- Remarks on result:
- not measured/tested
- Critical effects observed:
- not specified
- Key result
- Dose descriptor:
- NOAEC
- Generation:
- F1
- Effect level:
- 0.13 mg/L air (nominal)
- Sex:
- male/female
- Basis for effect level:
- organ weights and organ / body weight ratios
- other: Reproductive parameter
- Key result
- Dose descriptor:
- LOAEC
- Generation:
- F1
- Effect level:
- 1.3 mg/L air (nominal)
- Sex:
- male/female
- Basis for effect level:
- organ weights and organ / body weight ratios
- other: Reproductive parameter
- Key result
- Critical effects observed:
- no
- Key result
- Dose descriptor:
- NOAEC
- Generation:
- F2
- Effect level:
- 0.13 mg/L air (nominal)
- Sex:
- male/female
- Basis for effect level:
- organ weights and organ / body weight ratios
- other: Reproductive parameter
- Key result
- Dose descriptor:
- LOAEC
- Generation:
- F2
- Effect level:
- 1.3 mg/L air (nominal)
- Sex:
- male/female
- Basis for effect level:
- organ weights and organ / body weight ratios
- other: Reproductive paramter
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The US EPA, as part of the High Production Volume (HPV) Challenge Program has accepted a category proposal concerning bibasic esters. These are short, straight-chain dicarboxylic acid dimethyl esters that differ by one carbon atom (from four to six carbons) in chain length. The basis for considering dimethyl succinate, dimethyl glutarate, dimethyl adipate and a dibasic ester mixture containing all three as a Category is based upon the similarities of the three substances in structure, physicochemical properties and consistent responses in ecotoxicology and human health toxicology studies. The US EPA considers that the similarity in response makes read-across of data between members of the category both feasible and justifiable.
The source substance is a mixture containing the target substance, all being components of the mixture being dimethyl esters of acids which are metabolised to endogenous substances.
2. SOURCE AND TARGET CHEMICAL(S)
The source substance is a mixture consisting of 16.5% dimethyl succinate (the target substance), 17.0% dimethyl adipate and 66.0% dimethyl glutarate - Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- LOAEC
- Effect level:
- 0.16 mg/L air
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- histopathology: non-neoplastic
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 0.16 other: mg/L air
- System:
- respiratory system: upper respiratory tract
- Organ:
- nasal cavity
- Treatment related:
- yes
- Dose response relationship:
- yes
- Dose descriptor:
- NOEC
- Generation:
- F1
- Effect level:
- 1 mg/L air
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Reproductive effects observed:
- no
Referenceopen allclose all
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 296 mg/m³
- Study duration:
- subchronic
- Experimental exposure time per week (hours/week):
- 140
- Species:
- rat
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a one-generation reproductive toxicity study (Kelly, et.al., 1998) rats were exposed, by inhalation, to a mixture of dibasic esters containing dimethyl succinate, dimethyl glutarate and dimethyl adipate. Groups of 20 male and 20 female rats were exposed to concentrations of 0, 0.16, 0.40 or 1.0 mg/L for 6 hours/day, 5 days/week for 14 weeks during a pre-breeding period followed by 7 days/week for 8 weeks throughout a mating, gestation, and lactation periods. No significant differences related to treatment were noted on mating performance, fertility, length of gestation, numbers of pups, pup anomalies and viability. Body weights of both parental rats and their pups were reduced at 1.0 mg/L. Relative liver weight was increased in parental animals treated at 0.4 or 1.0 mg/L and relative lung weight was increased at 1.0 mg/L. A treatment related increase in squamous metaplasia in the olfactory epithelium was observed in parental animals. The NOAEC is considered to be 1.0 mg/L for reproductive performance of parental animals and for development of the off-spring.
In a two-generation reproductive toxicity study (OECD, 2004) on methanol, a metabolite of the registered substance, rats were exposed by inhalation to concentrations of 0, 0.013, 0.13 or 1.3 mg/L for 19-20 hours/day during a breeding period covering two generations. No significant differences related to treatment were noted on mating performance, fertility, length of gestation, numbers of pups, pup anomalies and viability. Male pups of the F1 and F2 generations from the highest exposure group exhibited some post-natal morphological differentiation with respect to the descent of the testes occurring 0.5 to 1 days earlier. This time-dependent parameter was evaluated by relating the completion of downward migration of the testes (final length of the gubernaculum reached) to the post-natal body-weight gain. The meaning of an apparent shift of testis descent in male offspring in relation to body-weight development of the pups is unclear and this parameter showed considerable variation also within the control group. In addition, absolute and relative brain weights were significantly lowered in the high-dose group pups of either sex at an age of 8 and 16 weeks. Although there was no obvious pathological effect in the progeny of groups exposed to 1.3 mg/L, the effects observed may be considered as biologically relevant under the described test conditions and, therefore, 1.3 mg/L (equivalent to 2.96 mg/L dimethyl succinate and considering that one molecule of dimethyl succinate will be metabolised to release two molecules of methanol), is established as a LOAEL and 0.13 mg/L (equivalent to 0.296 mg/L dimethyl succinate) as a NOAEL for post-natal development while for parental effects, the NOAEL is 1.3 mg/L (equivalent to 2.96 mg/L dimethyl succinate).
Effects on developmental toxicity
Description of key information
Developmental toxicity: In a developmental toxicity study with rats by the inhalation route with animals exposed 6 hours/day from Day 7 to 16 of gestation the NOAEC for developmental toxicity was considered to be 1.0 mg/L/day
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The US EPA, as part of the High Production Volume (HPV) Challenge Program has accepted a category proposal concerning bibasic esters. These are short, straight-chain dicarboxylic acid dimethyl esters that differ by one carbon atom (from four to six carbons) in chain length. The basis for considering dimethyl succinate, dimethyl glutarate, dimethyl adipate and a dibasic ester mixture containing all three as a Category is based upon the similarities of the three substances in structure, physicochemical properties and consistent responses in ecotoxicology and human health toxicology studies. The US EPA considers that the similarity in response makes read-across of data between members of the category both feasible and justifiable.
The source substance is a mixture containing the target substance, all being components of the mixture being dimethyl esters of acids which are metabolised to endogenous substances.
2. SOURCE AND TARGET CHEMICAL(S)
The source substance is a mixture consisting of 16.5% dimethyl succinate (the target substance), 17.0% dimethyl adipate and 66.0% dimethyl glutarate - Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- NOAEC
- Effect level:
- 1 mg/L air
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- Abnormalities:
- no effects observed
- Dose descriptor:
- NOAEC
- Effect level:
- 1 mg/L air
- Basis for effect level:
- other: Lack of treatment-related effects
- Developmental effects observed:
- no
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 1 000 mg/m³
- Study duration:
- subacute
- Experimental exposure time per week (hours/week):
- 42
- Species:
- rat
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a developmental toxicity study (Alvarez et.al., 1995) rats were exposed by inhalation to a mixture of bibasic esters containing dimethyl succinate, dimethyl glutarate and dimethyl adipate. Groups of pregnant rats were exposed to concentrations of the mixture of 0.16, 0.4 or 1.0 mg/L by inhalation daily for 6 hours/day from Day 7 through to Day 16 of gestation (Day 1 being designated as the day in which evidence of mating was detected). A control group of pregnant rats was exposed to air only. All animals were killed on gestation Day 21 and the foetuses examined. The mixture was regarded as not causing developmental toxicity in the rat following inhalation exposures at concentrations as high as 1.0 mg/L during the period of organogenesis and the NOAEC was 1.0 mg/L.
Justification for classification or non-classification
Based on the available data, classification and labelling according to Directive 67/548/EEC or Regulation 1272/2008 is not required.
Additional information
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.