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EC number: 945-069-6 | CAS number: -
- 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
In an acute oral limit test in rats with C9-11 branched alcohols, C10 rich diesters with nonanedioic acid no mortality/toxicity was observed at 2000 mg/kg bw. The LD50 is > 2000 mg/kg bw (Bien 1993).
For bis(2-ethylhexyl) azelate an oral LD50 of > 2000 mg/kg bw was found (Shirota 2003).
In an acute dermal limit test in rats with C9-11 branched alcohols, C10 rich diesters with nonanedioic acid no mortality/toxicity was observed at 2000 mg/kg bw. The LD50 is > 2000 mg/kg bw (van Otterdijk 2010).
For bis(2-ethylhexyl) azelate a dermal LD50 of 18300 mg/kg bw (20 ml/kg bw) was found in rabbits (Smyth 1962).
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Details on strain: Crj:CD(SD)IGS
- Source: Charles River Laboratories Japan, Inc., Yokohama, Japan
- Age at study initiation: 5 weeks
- Fasting period before study: from 4 pm one day before administration to 3 hours after administration
- Diet: CRF-2 (CLEA Japan, Meguro, Japan), ad libitum except fasting period
- Water: tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 - 24
- Humidity (%): 50.5 - 62
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed hourly up to 6 h post administration and once daily thereafter (including
weekends and holidays), and individual body weights were determined on Day 1, 2, 4, 8, 11 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- Student's t- test, Aspin-Welch test
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: Soft faeces were observed in control groups of both sexes after 1 to 6 hours of administration. But no other clinical signs were evident in male and female rats.
- Gross pathology:
- Cysts in right kidney were found in one male of control group. But no other abnormal changes were noted at necropsy in other males and females.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified - Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 Nov - 29 Nov 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions (test substance purtiy not given)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- , lack of details on test substance
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Niedersächsisches Umweltministerium, Hannover, Germany
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Bor: WISW (SPF cbp)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: males: 222-240 g, females: 161-181 g
- Fasting period before study: from 16 h before until 3-4 h after administration
- Housing: up to 5 animals per Makrolon type III cage on sterilised soft wood bedding.
- Diet: Ssniff-R Alleindiät, Ssniff Spezialdiäten GmbH, Soest, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 9 - 29 Nov 1993 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.17 mL/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 10 min, 1, 2, 6 and 24 h after application. Thereafter once daily.
- Frequency of weighing: On days 0, 7 and 14 p.a.
- Necropsy of survivors performed: yes, on all animals on day 14. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: No abnormal clinical signs were observed.
- Gross pathology:
- No test-item dependent findings were noted.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- based on studies with two structural analogues
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication which meets basic scientific principles. (Whole trunk was clipped for test substance application, only 4 animals used in test group, no data on clinical signs, mortality, body weight and gross pathology.)
- Principles of method if other than guideline:
- Rabbits were exposed dermally to the test substance for 24 hours.
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rabbit
- Strain:
- other: albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg - Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: entire trunk
- Type of wrap if used: impervious plastic film
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): up to 20 mL/kg bw - Duration of exposure:
- 24 hours
- Doses:
- no data
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- - during 24 hours exposure period animals are immobilized, during observation period animals are caged
- Duration of observation period following administration: 14 days - Statistics:
- LD50 value was calculated by the method of Thompson (Bacteriol. Rev. 11: 115, June 1947) using the tables of Weil (Biometrics, 8: 249, Sept. 1952).
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 20 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- 9.1 - 43.8
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 18 300 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: recalculated value with a density of 915 mg/mL at 25 °C (Lide, 2005)
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified - Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions; analytical purity of test material not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- analytical purity of test material not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 11-12 weeks
- Weight at study initiation: mean for males 323 g, mean for females 210 g, body weight variation did not exceed ± 20% of the sex mean
- Housing: individually housed in labeled Macrolon cages (MIII type, height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 05 Jan 2010 To: 19 Jan 2010 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 25 cm² for males and 18 cm² for females
- % coverage: 10
- Type of wrap if used: surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage, a piece of Micropore tape was additionally used for fixation of the bandages in females only
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was removed with tap water.
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.20 mL/kg bw
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Viability: Twice daily; Body weights: Days 1 (pre-administration), 8 and 15; Clinical signs: at periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Flat posture and/or chromodacryorrhoea was observed among several animals on Day 1. Scales were seen in the treated skin-area of several animals between Days 4 and 13.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Referenceopen allclose all
No data on mortality or clinical signs is given, body weight and gross pathology were not covered in this study
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- based on studies with two structural analogues
Additional information
Based on the information on the analogue substances and in view of the similarities of the components (and the starting materials) of the source and target chemicals the oral and dermal LD50 values for diesters of alcohols, C7-9-iso-, C8-rich, 2-ethylhexyl and nonanedioic acid are >2000 mg/kg bw (see attached rationale for read-across section 13).
Justification for classification or non-classification
Based on the outcome of the available studies on the analogue substances, no classification for diesters of alcohols, C7-9-iso-, C8-rich, 2-ethylhexyl and nonanedioic acid is considered according to EC No 1272/2008.
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