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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
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Endpoint summary
Administrative data
Description of key information
Read across from dodecanedioic acid (CAS 693-23-2) - Subchronic NOAEL (rat): 1800 mg/kg bw/day (OECD 408, GLP)
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-01-25 to 1999-04-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy S.r.l., San Pietro al Natisone (UD, Italy)
- Age: 27-29 days + 17 days acclimatization
- Weight at study initiation: males mean 209 g, females mean 162 g
- Housing: 5 of one sex per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 17 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 +/-2°C
- Humidity (%):55 +/- 10%
- Air changes (per hr): 15-20 per hour
- Photoperiod (hrs dark / hrs light):12/12 hours
IN-LIFE DATES: From: 25.01. 1999 To: 30.4.1999 - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- ADMINISTRATION / EXPOSURE
- Vehicle: polyethylene glycol 400
- Concentration in vehicle: 10, 60, or 360 mg/ml
- Total volume applied: 5 ml/kg bw/day - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of the formulations prepared in week 1 and 13 were analysed to check the concentration and homogeneity. The stability over a 24 hour
period was also checked on this occasion. Results of these analyses were within the limits of acceptance. - Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
50; 300; 1800 mg/kg bw/day
Basis: - No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: none (last dose on day before necropsy)
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS AND FREQUENCY:
- Clinical signs: Daily before plus 0, 1, and 2 hours after dosing for first 45 days. Thereafter the 2 hour observation was suspended as the
animals showed no signs. Detailed clinical examination including neurotoxicity evaluation once per week: Ease of removal from cage, handling
reactivity, lachrymation, palpebral closure, salivation, piloerection, rearing, mobility impairment, arousal, vocalization, stereotypies, respiratory
pattern, bizarre behavior, urination, defecation, clonic movements (5 types), tonic movements (5 types), abnormal gait (5 types).
Once during week 13 of treatment: Evaluation of sensory reactivity to stimuli of different modalities, assessment of grip strength.
Motor activity assessment during week 12 on 5 animals per sex and dose: Mini Opto-Varimex (Columbus International Corp.) recording device
using a computer-generated random order.
- Mortality: Twice daily including weekends and holidays
- Body weight: 7 + 0 days before first dosing, weekly thereafter, and prior to necropsy
- Food consumption: Weekly averages for each cage (i.e. 5 rats of same sex)
- Ophthalmoscopic examination: Performed at end of study.
- Hematology: Sampling during 13th week of treatment. Determination of hematocrit, hemoglobin, red blood cell count, (reticulocyte count not
performed due to absence of signs of anemia), mean red blood cell volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin
concentration, white blood cell count, differential leucocyte count (neutrophils, lymphocytes, eosinophils, basophil, monocytes, large unstained
cells), abnormalities of the blood film, platelets, prothrombin time.
- Biochemistry: Sampling during 13th week of treatment. Determination of alkaline phosphatase, alanine aminotransferase, aspartate
aminotransferase, urea, creatinine, glucose, albumin, total bilirubin, total cholesterol, total protein, sodium, potassium, calcium, chloride. - Sacrifice and pathology:
- ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Macroscopic: Detailed post mortem examination including external surfaces and orifices; weights of adrenal glands, brain, epididymides, heart,
kidneys, liver, ovaries, spleen, testes, thymus, uterus
- Microscopic: All animals of high dose and control groups: Abnormalities, adrenal glands, aorta, bone marrow (from sternum), brain, caecum,
colon, duodenum, epididymides, eyes, heart, ileum (including Peyer's patches), jejunum, kidneys, liver, lungs (including mainstem bronchi),
lymph nodes (cervical and mesenteric), mammary area, esophagus, ovaries, pancreas, parathyroid glands, pituitary gland, prostate gland, rectum,
salivary glands, sciatic nerve, seminal vesicles, skin, spinal cord, spleen, sternum, stomach, testes, thymus (where present), thyroid gland,
trachea, urinary bladder, uterus, vagina. - Statistics:
- STATISTICAL METHODS:
Standard deviations as appropriate. Analysis of variance for significance of differences in continuous variables amongst groups
Bartlett's test for homogeneity of data
Dunnett's test using a pooled error variance for differences between treated and control groups
Modified t test (Cochran and Cox) in case of inhomogeneous data - Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- one death (high dose group female); correlation between this death and the treatment with the test substance could not be established
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- one death (high dose group female); correlation between this death and the treatment with the test substance could not be established
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- These values were still within the range of historical control data and considered to be solely due to unusually low and consistent values in the control group, i.e. of no toxicological relevance.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- These changes were within historical control values and, therefore, they are considered to be of no toxicololgical relevance.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- considered to be of no toxicological significance
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- NOAEL (NOEL), LOAEL (LOEL): No changes of toxicological importance were seen at any of the dose levels investigated and, therefore, the
No Observed Adverse Effect Level (NOAEL) in this study is considered to be 1800 mg/(kg bw * d).
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
- Mortality and time to death: One female animal from the high-dose group died on day 7. On the basis of the observed clinical signs and necropsy
findings, the correlation between this death and the treatment with the test substance could not be established.
- Clinical signs: Daily post-dose observations showed only occasional instances of rales in mid-dose and piloerection in high-dose rats. Difficulty
in breathing, reduced activity, hunched posture, piloerection, dyspnoea and emaciated appearance were observed in the early decedent animal
prior to death.
Detailed clinical examination with neurotoxicity assessment did not show any significant signs.
Neurotoxicity tests and measurements performed at the end of treatment did not show changes attributable to the test substance.
A statistically significant increase in Motor Activity (+40 %, p<0.01) was observed in high-dose males.
- Body weight gain: No statistically significant differences were observed between control and treated groups.
- Food/water consumption: Food consumption was not affected by treatment.
- Ophthalmoscopic examination: No findings were seen.
- Clinical chemistry: A statistically significant increase in albumin (males +3.8 %, females +4.5 %, both p<0.05) and
chloride (males +2.3 %, p<0.01; females +1.5%, p<0.05) was seen in the high-dose rats.
The alkaline phosphatase (+24 %, p<0.05) and total bilirubin (+34 %, p<0.01) showed also a slight, but statistically significant increase in
high-dose males. These changes were within historical control values and, therefore, they are considered to be of no toxicololgical relevance.
- Hematology: There was a statistically significant increase in hematocrit in all treated female groups (low-dose +3.4 %, mid-dose +4.7 %,
high-dose +5.2 %, all p<0.01) and in red blood cell count (mid-dose +4.5 %, high-dose +4.0 %, both p<0.05) and hemoglobin (mid-dose +3.6 %,
high-dose +4.7 %, both p<0.01) in mid- and high-dose females. These values were still within the range of historical control data and considered
to be solely due to unusually low and consistent values in the control group, i.e. of no toxicological relevance.
- Organ weights: Some statistically significant increases (all p<0.05) observed in high-dose rats were considered to be of no toxicological
significance as they were not related to any morphological changes and were well within the range of historical control data:
epididymis (males) relative +8.1 % heart (females) absolute +6.3 %, relative +10 % (both also significant at low dose, not at mid dose)
kidney (females) +6.3 % adrenal (females) +11 %
- Gross pathology: Dark/red color of several organs and tissues, as well as decreased size of the spleen and the thymus were observed at necropsy
of the high-dose female that died on day 7. No macroscopic finding was described at post mortem examination of the animals sacrificed at
termination that could be considered correlated with the administration of the test substance.
- Histopathology: Congestion of several organs and athrophy of the spleen and the thymus were observed at the microscopic evaluation performed on the animal found dead. No significant difference was detected in the incidence of the pathological findings when treated animals were compared to controls. - Dose descriptor:
- NOAEL
- Effect level:
- 1 800 mg/kg bw/day (nominal)
- Sex:
- male/female
- Critical effects observed:
- not specified
- Conclusions:
- No changes of toxicological importance were seen at any of the dose levels tested and, therefore, the NOAEL was 1800 mg/kg bw/day.
- Executive summary:
A repeated dose oral 13 week study was conducted in rats with the test substance dodecanedioic acid. No changes of toxicological importance were seen at any of the dose levels tested and, therefore, the NOAEL was 1800 mg/kg bw/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 800 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The key study was the only study available and was a read across study from dodecanedioic acid (CAS 693-23-2). The study was assigned a Klimisch score of 2. The supporting study (14 day preliminary was a read across study from dodecanedioic acid (CAS 693-23-2)) was assigned a Klimisch score of X. When assessed together the overall quality of the database is high. This decreases the uncertainty in the prediction of the NOAEL for tridecanedioic acid (CAS No. 505-52-2).
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There is no repeated dose toxicity data available for tridecanedioic acid (CAS No. 505-52-2) A read-across approach was conducted with data from a 90 day oral repeated dose toxicity study from dodecanedioic acid (CAS 693-23-2).
The complete read across justification is attached as document.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Only 1 key study available.
Justification for classification or non-classification
Based on available information in the dossier, the substance tridecanedioic acid (CAS No. 505-52-2) does not need to be classified as specific target organ toxicity (repeated) when considering the criteria outlined in Annex I of 1272/2008/EC based on the results of the read-across study from dodecanedioic acid (CAS 693-23-2).
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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