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EC number: 442-490-2 | CAS number: 871-70-5 EMEROX 118
- 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
- Remarks:
- other: acute oral toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well-documented GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,18-octadecanedioic acid
- EC Number:
- 442-490-2
- EC Name:
- 1,18-octadecanedioic acid
- Cas Number:
- 871-70-5
- Molecular formula:
- C18H34O4
- IUPAC Name:
- octadecanedioic acid
- Reference substance name:
- Octadecanedioic acid
- EC Number:
- 617-978-5
- IUPAC Name:
- Octadecanedioic acid
- Test material form:
- solid: flakes
- Details on test material:
- Purity: 100% active matter
Remarks: White, solid.
Solubility: Poorly soluble (=< 2 mg/L in test medium).
Carbon chain length distribution: C16 2,98%, C18 92,9%, C18:1 1,04%
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 mg test substance/kg bw
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- LOEL
- Effect level:
- > 1 000
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Practically nontoxic. The 28-day NOAEL for 1,18-octadecanedioic acid in rats is 1,000 mg/kg bw.
No significant differences in weight gain between the test- and controlgroups could be detected in female animals, on the 95% confidential level.
For the male HD group a marked reduced weight gain was observed, which also showed significant difference, on the 95% confidential level. This
finding is assumed to be compound-related. This finding was neither confirmed by histopathology nor any of the other evaluated parameters.
The mean weight gain in all groups was less as expected according to the standard growth curve for this strain. These diminished weight gains are due
to the daily treatment which is combined with mechanical manipulation and therefore with increased stress for the animals.
Upon histopathology the following treatment related findings were recorded:
Results:
There were no treatment-related changes.
Commentary:
There were two treated male rats with mild tubular degeneration of the kidneys and none in controls. The change was present unilaterally in both cases suggesting that these were fortuitous observations, not associated with treatment. The other occasional changes are those that are commonplace in young laboratory rats. The determination of clinical chemical pararneters revealed that all mean and mostindividual values (GOT, GPT, AP, TP, Urea, Crea, Na, K) were within the expected range. Single deviations are deemed to be of no toxicological relevance. There were no toxicologically relevant results in relative and absolute organ weight for both sexes and any ofthe groups.
In the assessment of the haematology-values (Hct, Hb, RBC, WBC, Platelets, aPTT) no changes of toxicological relevance were found. Compound-relation was not detectable.
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