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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
Endpoint summary
Administrative data
Description of key information
No skin irritation was observed in an acute dermal toxicity study (2000 mg/kg body weight)
According the REACH Regulation column 2 in Annex VII “in vitro study for skin corrosion and in vivo study for skin irritation does not need to be conducted if an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg body weight).”
Based on the read across to the source chemical dodecanedioic acid, which is classified as H319, causes serious eye irritation, the target chemical tridecanedioc acid is also classified as H 319.
Serious eye damage/eye irritation: The substance tridecanedioic acid is classified as H319, causes serious eye irritation. Therefore a study on eye irritation is not foreseen according to Annex VII , Chapter 8.2 , column 2.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1989-02-14 to 1989-05-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The target substance tridecanedioic acid and its analogue dodecanedioic acid are both unsubstituted linear aliphatic dicarboxylic acids differing in chain length by only one methylene (CH2) group. The functional groups of both substances are identical, namely: carboxylic acid and methylene groups. There is no difference in their arrangement in the molecular structure. The only difference between source structure and target structure is an increase in the number of methylene groups from 10 to 11. Since already 10 methylene groups are present in the source structure, no qualitative change and no significant quantitative change in chemical and biological activities is to be expected upon adding one more methylene group. It is therefore suggested that read across can be performed for complex biochemical endpoints based on the close structural similarity between dodecanedioic acid and its analogue tridecanedioic acid.
- Data waiving:
- other justification
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male
- Number of animals: 6 males
- Controls: untreated eye
- Weight at study initiation: 2.1-2.6 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14.02 1989 To: 17.05.1989 - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- ADMINISTRATION/EXPOSURE
- Concentration: undiluted
- Amount applied: 0.1 g
- Preparation of test substance: grinding in mortar
- Vehicle: none
- Postexposure observation period: 13 days - Duration of treatment / exposure:
- 72 hour(s)
- Observation period (in vivo):
- - Postexposure observation period: 13 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Comment: rinsed after 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6, 7, 8, 10 and 13 days after treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual inspections
- Scoring system: Draize (1959); evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.44
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 2.5
- Reversibility:
- fully reversible
- Remarks on result:
- other: erythema
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 1.06
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.44
- Conjunctivae (Redness): 2.50
- Conjunctivae (Chemosis): 1.06
- Overall irritation score: 11.96/110 - Other effects:
- REVERSIBILITY: complete within 10 days
OTHER EFFECTS: There were no indications of mechanical irritation by the finely ground solid test material. Conglutination of eyelids was observed
in the males at 24 or at 48 hours. - Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
- Conclusions:
- In this study, dodecanedioic acid was an eye irritant.
Read across can be performed for complex biochemical endpoints based on the close structural similarity between dodecanedioic acid and its analogue tridecanedioic acid.
Therefore the target substance tridecanedioic acid will also be classified as an eye irritant - Executive summary:
In a primary eye irritation study 0.1 g of dodecanedioic acid was instilled into the conjunctival sac of the right eye of six male young adult White Russian rabbits. Animals then were observed for 13 days.
Cornea were not affected. Iris was very mild and reversibly affected. Chemosis and erythema were recorded for conjunctival effects, mean score (24 -72h) was 2.5 for iridal redness. Eyes were normal with 1 - 7 days. In this study, dodecanedioic acid was an eye irritant..
Reference
no effects on cornea
Animal No |
Iris, Observation time |
||||
1 h |
24 h |
48 h |
72 h |
6-13 days |
|
57889 |
1 |
0 |
0 |
0 |
0 |
58051 |
1 |
0 |
0 |
0 |
0 |
58057 |
1 |
1 |
1 |
0 |
0 |
70115 |
1 |
1 |
0 |
0 |
0 |
70293 |
1 |
1 |
1 |
1 |
0 |
70327 |
1 |
1 |
1 |
0 |
0 |
The target substance tridecanedioic acid and its analogue dodecanedioic acid are both unsubstituted linear aliphatic dicarboxylic acids differing in chain length by only one methylene (CH2) group. The functional groups of both substances are identical, namely: carboxylic acid and methylene groups. There is no difference in their arrangement in the molecular structure. The only difference between source structure and target structure is an increase in the number of methylene groups from 10 to 11. Since already 10 methylene groups are present in the source structure, no qualitative change and no significant quantitative change in chemical and biological activities is to be expected upon adding one more methylene group. It is therefore suggested that read across can be performed for complex biochemical endpoints based on the close structural similarity between dodecanedioic acid and its analogue tridecanedioic acid.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No skin irritation was observed in an acute dermal toxicity study (2000 mg/kg body weight) for tridecanedioic acid, therefore the substance is not irritating. Based on a read across to source chemical dodecanedioic acid, the substance tridecanedioic acid is classified as irritating to eyes.
The complete read across justification is attached as document.
Justification for selection of skin irritation / corrosion endpoint:
An acute dermal toxicity study was conducted according to OECD and GLP (LPT 2013), with the results of no skin irritation at the limit dose level of 2000 mg/kg bw. Therefore a skin irritation/corrosion study is waived based on the REACH Regulation column 2 in ANNEX VII “in vitro study for skin corrosion and in vivo study for skin irritation does not need to be conducted if an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg body weight).”
Justification for selection of eye irritation endpoint:
The substance tridecanedioic acid is classified as H319, causes serious eye irritation, based on a read across to source chemical dodecanedioic acid.
Effects on eye irritation: irritating
Justification for classification or non-classification
Based on the available information in the dossier, the substance tridecanedioic acid (CAS No. 505-52-2) is classified for serious eye damage/eye irritation (Category 2; H319: Causes serious eye irritation) when considering the criteria outlined in Annex I of 1272/2008/EC.
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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