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EC number: 271-678-5 | CAS number: 68603-87-2
- 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
Dicarboxylic acid mixture is of low acute toxicity after oral or dermal exposure. Although no reliable inhalation study is available low toxicity by inhalation is also anticipated based on low acute toxicity data reported for adipic acid.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Animals were observed for 14 days
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 6 dose level; 3160; 3980; 5010; 6310; 7940; 10000 mg/kg bw
- No. of animals per sex per dose:
- 2-3 males; 2-3 females; overall 5 animals per dose group
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 3 980 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 6 000 mg/kg bw
- 95% CL:
- >= 5 400 - <= 6 720
- Mortality:
- see Table 1
- Interpretation of results:
- GHS criteria not met
- Executive summary:
An oral LD50 value of 6000 mg/kg (95% confidence limits 5400 - 6720 mg/kg) was reported in rats in study similar to OECD TG 401 with doses up to 10000 mg/kg. In this study a 20% aqueous solution of a dicarboxylic acid mixture was tested and mortality was seen during the first 4 days; most deaths were reported within the first day. Signs of intoxication were weight loss (one day in survivors), increased weakness, salvation, collapse and death. Lethal doses caused hemorrhagic lungs, liver, kidney and spleen discoloration and acute gastrointestinal inflamation. Animals that survived to termination (day 14) appeared normal.
Reference
Signs of intoxication: weight loss (one day in survivors), increasing weakness, salvation, collapse and death.
Gross autopsy:
5010 and 6310 mg/kg group: Hemorrhagic lungs, liver, kidney and spleen discoloration and acute gastrointestinal inflamation.
7940 and 10000 mg/kg group: Lung and liver hyperemia
Survivors (day 14): Viscera appeared normal.
Table 1: mortalities
Dosage (mg/kg bw) | mortality males | mortality females | mortality combined |
3160 | 0/3 | 0/2 | 0/5 |
3980 | 0/2 | 0/3 | 0/5 |
5010 | 1/3 | 0/2 | 1/5 |
6310 | 0/2 | 3/3 | 3/5 |
7940 | 3/3 | 2/2 | 5/5 |
10000 | 2/2 | 3/3 | 5/5 |
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 6 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substance have similar toxicological properties because they share structural similarities with common functional groups, varying solely in their length. This prediction is supported by experimental data for environmental fate, ecotoxicity and human health toxicology on the multi-constituent target substance, the source substance and on further constituents of the target substance.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target Glutaric acid, tech. (CAS No. 68603-87-2) is a multi-constituent substance, consisting of C4-, C5- and C6- dicarboxylic acids. The source substance Adipic acid (CAS No 124-04-9, C6-dicarboxylic acid) is one of the main components of the target substance. Additionally, target and source exhibit the same core structure as they are based on linear carbon chains with same acidic moieties, varying solely in chain lengths. Adipic acid thus serves as a structural representative of glutaric acid, tech.. No relevant impurity was identified for the boundary composition of Glutaric acid tech. and adipic acid.
3. ANALOGUE APPROACH JUSTIFICATION
The prediction is supported by experimental data on the multi-constituent target substance and the source substance showing comparable properties regarding physico-chemistry, ecotoxicology and human health toxicology. Therefore, read-across from toxicity studies on the source substance is considered as an appropriate adaption to the standard information requirements for the target substance.
For detailed information see the RAAF document attached to the IUCLID:
‘Justification for a read-across approach from Adipic acid (cAS no. 124-04-9) [Source] to Glutaric acid, tech. (CAS No 68603-87-2) [Target] - Reason / purpose for cross-reference:
- read-across source
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- 7 700 mg/m³ air
- Exp. duration:
- 4 h
- Remarks on result:
- other: no mortalities observed
- Mortality:
- No mortalities observed at a concentration of 7700 mg/m³ of the source adipic acid. It can be concluded that for the target dicarboxylic acid mixture no relevant toxic effects up to the limit concentration are expected.
- Clinical signs:
- other: Nothing abnormal observed
- Gross pathology:
- Nothing abnormal observed
- Conclusions:
- In the acute inhalation toxicity study with the constituent adipic acid at the maximal attainable concentration of 7700 mg/m³ no signs of toxicity and also no macroscopic pathological changes were observed. This concentration can therefore be regarded as LC0.
- Executive summary:
The concentration of 7700 mg/m³ can be regarded as LC0 in the source acute inhalation toxicity study. As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to distinct differences in acute inhalation toxicity. The acidic nature of target and source is expected to be the critical effect in acute inhalation toxicity studies and no relevant quantitative differences in local effects and thus no acute inhalation toxicity of dicarboxylic acid mixture can be expected.
Reference
Neither mortality nor symptoms were observed during and after exposure. No pathological changes were reported at necropsy.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Animals were dosed with 40% aqueous solutions for 24 hours and observed for 14 days.
one female rabbit was dosed with 5010 mg/kg.
one female and one male rabbit were dosed with 7940 mg/kg - GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Type of coverage:
- not specified
- Vehicle:
- water
- Duration of exposure:
- 24 hours
- Doses:
- 5010 and 7940 mg/kg
- No. of animals per sex per dose:
- 5010 group: one female
7940 mg/kg group: one female and one male - Control animals:
- not required
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 7 940 mg/kg bw
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD0 > 7940 mg/kg
- Executive summary:
No mortality was reported in an acute dermal toxicity experiment in rabbits following administration of 5010 mg/kg (n=1) or 7940 mg/kg (n=2) of a 40% aqueous solution/suspension of dicarboxylic acid mixture. The only clinical signs reported were weight loss during the first 2 to 4 days. The viscera appeared normal at termination after 14 days. The LD50 was thus > 7940 mg/kg bw.
Reference
Signs of intoxication: wieght loss (two to four days)
Gross autopsy: viscera appeared normal
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 7 940 mg/kg bw
Additional information
An oral LD50 value of 6000 mg/kg (95% confidence limits 5400 - 6720 mg/kg) was reported in rats in a study similar to OECD TG 401 with doses up to 10000 mg/kg. In this study a 20% aqueous solution of a dicarboxylic acid mixture was tested and mortality was seen during the first 4 days; most deaths were reported within the first day. Signs of intoxication were weight loss (one day in survivors), increased weakness, salvation, collapse and death. Lethal doses caused hemorrhagic lungs, liver, kidney and spleen discoloration and acute gastrointestinal inflammation. Animals that survived to termination (day 14) appeared normal (Monsanto, 1979). Two additional studies report LD50 values of 5000 mg/kg and 2207 mg/kg and support the low acute oral toxicity of dicarboxylic acid mixture.
No mortality was reported in an acute dermal toxicity experiment in rabbits following administration of 5010 mg/kg (n=1) or 7940 mg/kg (n=2) of a 40% aqueous solution/suspension of dicarboxylic acid mixture. The only clinical signs reported were weight loss during the first 2 to 4 days. The viscera appeared normal at termination after 14 days.
There are no reliable data studies available to evaluate the acute inhalation toxicity of dicarboxylic acid mixture. In a study with limited reliability five rats per sex were whole body exposed for 4 hours to dicarboxylic acid mixture aerosols at a single analytical concentration of 0.03 mg/l. The filters used avoids particles > 5 µm. All animals were observed for 14 days for mortality and clinical signs of toxicity. Body weights were recorded before exposure and at weekly intervals. No clinical signs or body weight effects as well as no adverse necropsy findings were recorded (BASF, 1979).
Reliable data on acute inhalation toxicity are available for the read-across source adipic acid. In a study similar to OECD TG 403 no mortality, toxicity or macroscopic pathological changes were observed in 20 rats exposed for 4 h (nose only) to the maximal attainable concentration of 7700 mg/m³ of adipic acid dust. 50% of the particles had a MMAD below 3.5 µm.
The concentration of 7700 mg/m³ can be regarded as LC0 in the source acute inhalation toxicity study. As explained in the justification for type of information, the differences in molecular structure between the target and the source unlikely to lead to substantial differences in acute inhalation toxicity. The acidic nature of target and source is expected to be the critical effect in acute inhalation toxicity studies and no relevant quantitative differences in local effects and thus no acute inhalation toxicity of dicarboxylic acid mixture can be expected.
The neat glutaric acid (C5-dicarboxylic acid) and succinic acid (C4-dicarboxylic acid) also showed a very low acute oral toxicity with LD50 values of well above 2000 mg/kg bw. The acute dermal toxicity was determined with > 7000 mg/kg bw for the neat glutaric acid. No data are available for acute dermal toxicity of succinic acid and acute inhalation toxicity of glutaric and succinic acid.
Justification for classification or non-classification
No classification is required according to the classification criteria 67/548/EWG and EU regulation no. 1272/2008 (GHS).
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