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Diss Factsheets
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EC number: 940-822-5 | 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: recent GLP and OECD guideline study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 003
- Reference Type:
- secondary source
- Title:
- Bis(2-ethylhexyl) azelate
- Author:
- OECD
- Year:
- 2 006
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 22, Paris, France, 18-21 April, 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Bis(2-ethylhexyl) azelate
- EC Number:
- 203-091-7
- EC Name:
- Bis(2-ethylhexyl) azelate
- Cas Number:
- 103-24-2
- IUPAC Name:
- bis(2-ethylhexyl) azelaate
- Details on test material:
- - Name of test material (as cited in study report): Bis(2-ethylhexyl)nonanedioate
- Analytical purity: 77.2%
- Impurities (identity and concentrations):
Bis(2-ethylhexyl)glutarate 2.2%,
Bis(2-ethylhexyl)adipate 2.4%,
Bis(2-ethylhexyl)pimelate 2.8%,
Bis(2-ethylhexyl)suberate 3.8%,
Bis(2-ethylhexyl)sebacate 3.3%,
Bis(2-ethylhexyl) 1-,9-nonamethylenedicarboxylate 5.3%,
Bis(2-ethylhexyl)1-,10-decamethylenedicarboxylate 0.6%,
Bis(2-ethylhexyl)1-,11-undecamethylenedicarboxylate 0.3%
- Lot/batch No.: N-31101
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crj:CD(SD)IGS
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Males: 14 days before mating, 28 days afterwards Females: total of 42-53 days beginning 14 days before mating to day 4 of lactation
- Frequency of treatment:
- 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300, 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 13
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: clinical chemistry; body weight; organ weight
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: clinical chemistry; body weight; organ weight
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
CLINICAL SIGNS AND MORTALITY: There was no mortality related to the test
substance treatment. No changes were observed on general clinical
observation, nor were scores obtained by detailed clinical observations
between control and the test substance-treated groups.
BODY WEIGHT AND WEIGHT GAIN
Body weight gain was suppressed in males of the 1000 mg/kg
bw/day-treated group (see Table 1)
FOOD CONSUMPTION
No effects were observed in males and females of the test
substance-treated groups.
HAEMATOLOGY
No effects were observed in males of the test substance-treated groups.
A decrease in white blood cells (WBC) and a shorter activated partial
thromboplastin time were observed in females of the 1000 mg/kg bw/day
dose group. But these change were not considered as adverse effects
because of no accompanying changes. A decrease in WBC was observed in
females of the 1000 mg/kg bw/day dose group.
CLINICAL CHEMISTRY
An increase in albumin/globulin (A/G) ratio was found in males at 1000
mg/kg bw/day and in females at 300 mg/kg bw/day and higher. Decreases in
total protein, creatinine and calcium were observed in females at 1000
mg/kg bw/day. The increase in A/G ratio noted in females at 300 mg/kg
bw/day was not considered as an adverse effect because of no
accompanying changes (see Table 2). Decreases in glucose and alkaline
phosphatase observed in females of 100 mg/kg bw/day group and 300 mg/kg
bw/day, respectively, were incidential observations and thus considered
non-adverse.
NEUROBEHAVIOUR
No neurobehavioural abnormalities were observed in the test
substance-treated groups.
ORGAN WEIGHTS
Increases in a relative weight of liver and absolute and relative
weights of kidney for males and increases in relative weights of liver
and kidney for females were observed in the 1000 mg/kg bw/day group (see
Table 3).
GROSS PATHOLOGY
No adverse effects were observed for males and females.
HISTOPATHOLOGY: NON-NEOPLASTIC
Tendency of increase in hypertrophy of centrilobular hepatocytes and a
reduction in the grade of periportal fatty change were observed in males
of the 1000 mg/kg bw/day group
Applicant's summary and conclusion
- Conclusions:
- Based on the findings observed at 1000 mg/kg bw/day, the NOAEL for repeated dose toxicity was considered to be 300 mg/kg bw/day.
- Executive summary:
The repeated dose toxicity of bis(2-ethylhexyl) azelate was studied in a combined repeated dose and reproductive / developmental toxicity screening test according to the OECD 422 guideline. Male animals (13 per dose) received the test substance every day, starting 14 days before mating until 28 days afterwards. Female animals (13 per dose) received the test substance every day, starting 14 days before mating until day 4 of lactation. Total exposure duration therefore is between 42 and 53 days. The daily dose was 100, 300 or 1000 mg/kg bw/d.
Based on findings of increased relative liver and kidney weights, a tendency for increase in hypertrophy of centrilobular hepatocytes and a reduction in the grade of periportal fatty change observed in animals of the highest dose group, a NOAEL of 300 mg/kg bw/d was established.
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