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EC number: 268-597-2 | CAS number: 68130-55-2
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.9 (Repeated Dose (28 Days) Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- except sites were not occluded and residual test material not wiped off
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hexanedioic acid, mixed esters with decanoic acid, heptanoic acid, octanoic acid and pentaerythritol
- EC Number:
- 268-597-2
- EC Name:
- Hexanedioic acid, mixed esters with decanoic acid, heptanoic acid, octanoic acid and pentaerythritol
- Cas Number:
- 68130-55-2
- Molecular formula:
- C36H64O10
- IUPAC Name:
- 6-[3-(decanoyloxy)-2-[(heptanoyloxy)methyl]-2-[(octanoyloxy)methyl]propoxy]-6-oxohexanoic acid
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Details on exposure:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material not wiped off
Test article was applied to the clipped backs of four groups of Sprague-Dawley rats - Duration of treatment / exposure:
- 5-Days a week for 4-weeks
- Frequency of treatment:
- 5-Days a week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Post-exposure recovery period in satellite groups: Only for control and high dose animals
Examinations
- Statistics:
- Analysis of variance (ANOVA), associated F-test, Dunnett's test or Tukey's multiple range test.
Results and discussion
Results of examinations
- Description (incidence and severity):
- Animals treated with test article exhibited no signs indicative of systemic toxicity. The test material was not visibly irritating to the skin at the exposure site.
- Description (incidence and severity):
- Animals exposed to test article at 2000 mg/kg/day gained slightly less weight than untreated controls, achieving statistical significance in the male regular group and in the female satellite group.
- Description (incidence and severity):
- Exposure to the test article had no effect on food consumption.
- Description (incidence and severity):
- Statistically significant (p<0.05) differences were observed between the data from the untreated control groups and the treated groups for 2 of the 13 hematology parameters evaluated at week 5.
Segmented neutrophils were statistically significantly increased in the female mid-dose group. A linear relationship was not found between dose and blood level for this parameter.
Lymphocytes were decreased in the male treated satellite group at both weeks 5 and 7. When the historical serum reference values were taken into consideration, the mean value for this parameter at weeks 5 and 7 fell within the normal range as defined by the 10th and 90th percentiles of the historical data. Statistically significant (p<0.05) differences were observed between the data from the untreated control groups and the groups treated with test article for 2 of the 19 serum chemistry parameters evaluated at week 5.
Aspartate aminotransferase was statistically significantly increased in the female low-dose group. A linear relationship was not found between dose and serum level for this parameter.
Alanine aminotransferase was increased in the male treated satellite group. When the historical serum reference values were taken into consideration, the mean value for this parameter fell slightly above the 90th percentile of the historical data. This finding was not considered to be biologically significant because the value was only slightly outside the normal range of the historical data and a similar effect was not observed in the other treated groups. One statistically significant difference (decreased albumin in males) was observed between the serum chemistry data from control and treated animals following the 2-week recovery period. This finding, while falling just outside the normal range (4.5-5.0 g/dL) of the historical data, was not considered to be biologically significant because of the small magnitude of the decrease (3%), and this parameter was not affected at week 5. - Description (incidence and severity):
- No test material-related findings were observed at the time of necropsy.
No significant differences were seen between the absolute and relative organ weight data of the control and treated regular groups.
A significant increase was seen in the relative adrenal and brain weights of the females exposed to test material at 2000 mg/kg/day and sacrificed after a two-week recovery period when compared to those of the untreated controls. This difference is attributed to the statistically significant lower final body weights of the treated animals. Microscopically, the test material-related findings were only observed in the treated skin of the rats exposed to the test material at 500 mg/kg/day. Generally these findings were very minor and consisted of a dose-related increased incidence and severity of hyperplasia and hyperkeratosis of the epidermis and sebaceous gland hyperplasia. Microscopic evaluation of the satellite animals showed no differences between the control and treated animals, indicating complete reversibility after the 2-week recovery period.
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: hyperplasia and hyperkeratosis of the epidermis and sebaceous gland hyperplasia
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 500 mg/kg bw/day (nominal)
- System:
- integumentary
- Organ:
- skin
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In conclusion, a conservative NOEL was established to be 500 mg/kg/day for systemic toxicity.
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