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EC number: 208-011-4 | CAS number: 505-52-2
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-09-03 to 2012-09-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (2001)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Version / remarks:
- (2002)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Tridecanedioic acid
- EC Number:
- 208-011-4
- EC Name:
- Tridecanedioic acid
- Cas Number:
- 505-52-2
- Molecular formula:
- C13H24O4
- IUPAC Name:
- tridecanedioic acid
- Reference substance name:
- Brassylic acid
- IUPAC Name:
- Brassylic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Brassylic acid/Tridecanedioic acid
- Physical state:White powder
- Analytical purity: 99.42 %
- Lot/batch No.:3311050098 of 22 August 2011
- Expiration date of the lot/batch:27 Jun 2013
- Storage condition of test material: At room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: CD / Crl: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at start of administration: Approx. 8 weeks
- Weight at start of administration: 164 - 183 g
- Fasting period before study:
- Housing: During the 14-day observation period the animals were kept in groups of 3 animals in MAKROLON cages (type III plus). Granulated textured wood was used as bedding material for the cages.
- Diet:Commercial diet, ssniff® R/M-H V1534 (Certificates of analysis provided) ; discontinued approx. 16 hours before administration
- Water: tap water ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 12 to 18-fold air change per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light (about 150 lux at approx. 1.50 m room height)
IN-LIFE DATES: From: August 21, 2012 To:September 18, 2012
IN-LIFE DATES: From: August 21, 2012; To:September 18, 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.8% aqueous hydroxypropylmethylcellulose
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no. (if required): 11 A 27-N27
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A limit test at one dose level of 2000 mg/kg bw was carried out on 6 female animals - Doses:
- 2000 mg/kg bw (limit test)
- No. of animals per sex per dose:
- 6 female animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days. Individual body weights were recorded before administration of the testsubstance and thereafter in weekly intervals up to the end of the study.
- Necropsy of survivors performed: yes (all animals)
- Other examinations performed: changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory,autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Any tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma were also noted. - Statistics:
- No statistical analysis was performed as the method used is not intended to allow a calculation of a precise LD50 value.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: 24 hrs and 14 days
- Mortality:
- No death was recorded within the test period.
- Clinical signs:
- other: No clinical signs were noted.
- Gross pathology:
- No pathological changes were observed at necropsy.
- Other findings:
- - Histopathology:
No histopathology was carried out as no macroscopical findings were noted at autopsy.
Any other information on results incl. tables
Study report attachment:
LPT 28719 (Table 3 Bodyweights)
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this acute oral toxicity study in rats (limit test), the LD 50 (females) for Brassylic acid was > 2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study, 6 female rats (CD/Crl: CD(SD) were given a single oral dose of Brassylci acid in 0.8% aqueous hydroxypropylmethylcellulose by gavage at a dose of 2000 mg/kg bw.
Animals were then observed for 14 days. There were no deaths and no treatment-related clinical signs, necropsy findings or changes in body weight during the study.
Oral LD50 Females = > 2000 mg/kg bw (Limit test with no mortalities)
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