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EC number: 208-010-9 | CAS number: 505-48-6
- 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
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-04-17 - 2018-05-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Suberic acid
- EC Number:
- 208-010-9
- EC Name:
- Suberic acid
- Cas Number:
- 505-48-6
- Molecular formula:
- C8H14O4
- IUPAC Name:
- octanedioic acid
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Molecular formula: C8H14O4
Molecular Mass:
174.20
Characteristics (Physical Appearance):
White Crystalline powder
CAS No.:
505-48-6
Batch Number:
308
Purity:
100%
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and justification for the selection of the species:
Rat (Rattus norvegicus); The regulatory guidelines for this test has preferred rat among the species of rodents.
Strain:
Wistar; The strain was selected due to its availability in requisite numbers.
Sex:
Female only. It has been observed that females are generally slightly more sensitive than males to toxic effects. The selected females were nulliparous and non-pregnant.
Source:
National Institute of Biosciences, Pune, India
Age at start of treatment:
Between 8 to 12 weeks
Weight range at start of the treatment (Day -1):
160 g to 187 g
Route of administration and justification of its choice:
Oral, through gavage. The oral route is an accidental route of exposure in humans.
No. of dose groups:
Four: Step-1 and 2: 300 mg/kg ; Steps-3 and 4 : 2000 mg/kg body weight
No. of animals per dose group:
Three
Veterinary examination:
Prior to assignment to the study, the animals were subjected to a veterinary examination to ensure that the selected rats were in a good state of health.
HOUSING AND FEEDING CONDITIONS
Environmental conditions:
The experimental animal room was supplied with fresh and filtered air, with 10 to 15 air changes per hour. The room was air conditioned with temperature between 19 to 25 °C, relative humidity 30 to 70% and illumination cycle was set to 12 hours light and 12 hours dark.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: analytical grade water with 0.2% Tween 80
- Details on oral exposure:
- The test item was administered by oral gavage to each rat as a single dose using a suitably graduated syringe and a stainless steel intubation needle (16G). The dose administered to individual rat was adjusted according to its body weight that was recorded just before dosing to give a constant dosage volume of 10 ml/kg body weight.
- Doses:
- Step-1 and 2: 300 mg/kg ; Steps-3 and 4 : 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6
- Control animals:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- SUBERIC ACID did not cause any mortality and abnormal clinical signs on the day of dosing and also throughout the observation period following dosing.
- Gross pathology:
- No gross pathological alterations were encountered in any of the female rats when sacrificed at termination of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Acute oral toxicity study of SUBERIC ACID in Wistar rats was performed as per Organization for Economic Co-operation and Development (OECD) Guideline for Testing of Chemicals, Section 4, No. 423 - Acute Oral Toxicity - Acute Toxic Class Method, adopted by the council on 17 December, 2001.
Based on the findings of this study and according to the criteria for classification (described under 3.5) viz. "Globally Harmonised System (GHS) for classification of chemicals which cause acute toxicity, Seventh Revised Edition (ST/SG/AC.10/30/Rev.7); United Nations, New York and Geneva, 2017; eISBN 978-92-1-060457-4, United Nations, 2017 and also the Classification, Labelling and Packaging of Substances Regulation (Regulation 1272/2008/EC), the test item, SUBERIC ACID is classified in GHS Category 5 or unclassified for the obligatory labelling requirement for oral toxicity, the corresponding LD50 cut-off value being 5000 mg/kg body weight. - Executive summary:
Acute oral toxicity study of SUBERIC ACID in Wistar rats was performed as per Organization for Economic Co-operation and Development (OECD) Guidelines for Testing of Chemicals, Section 4, No. 423 - Acute Oral Toxicity - Acute Toxic Class Method, adopted by the council on 17 December, 2001. The method uses pre-defined doses and the results allow a substance to be ranked and classified according to the Globally Harmonised System (GHS) for classification of chemicals which cause acute toxicity.
In this study, single oral administration of SUBERIC ACID was made to groups of three female Wistar rats in step-wise manner to assess its acute toxicity.
The test item was formulated in analytical grade water with 0.2% Tween 80 to obtain concentrations of 30 mg/ml and 200 mg/ml.
Following the starting dose of 300 mg/kg body weight, which was also repeated in the step 2 of the study, SUBERIC ACID did not cause death of any of the treated female rats and did not induce any signs of toxicity. Body weights of treated rats were not adversely affected during the observation period. No gross pathological alterations were encountered in any of the female rats when sacrificed at termination of the study.
Following step 3, at the dose of 2000 mg/kg body weight, which was also repeated in step 4 of the test, SUBERIC ACID did not cause death of any of the treated rats and did not induce any signs of toxicity. Body weights of treated rats were not adversely affected during the observation period. No gross pathological alterations were encountered in any of the female rats when sacrificed at termination of the study.
Based on these results, and according to the criteria for classification (described under section 3.5 of this report) viz. Globally Harmonised System (GHS) for classification of chemicals which cause acute toxicity, Seventh Revised Edition (ST/SG/AC.10/30/Rev.7); United Nations, New York and Geneva, 2017; eISBN 978-92-1-060457-4, United Nations, 2017 and the EC Requirements for Classification and Labelling of Dangerous Substances (Commission Directive 2001/59/EC of 6th August 2001 adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the Classification, Packaging and Labelling of Dangerous Substances. Official Journal of the European Communities OJL 225 pp. 1-333), the test item, SUBERIC ACID, is classified in GHS Category 5 or unclassified for the obligatory labelling requirement for oral toxicity, the corresponding LD50 cut-off value being 5000 mg/kg body weight.
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.
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