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Diss Factsheets
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EC number: - | 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: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Stearic anhydride
- EC Number:
- 211-318-6
- EC Name:
- Stearic anhydride
- Cas Number:
- 638-08-4
- Molecular formula:
- C36H70O3
- IUPAC Name:
- octadecanoic anhydride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Vehicle:
- water
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- five days per week
- No. of animals per sex per dose:
- 0 (G1, Control), 250 (G2, Low dose), 500 (G3, Intermediate dose) and 1000 (G4, High dose), 0 (G1R, Control recovery) and 1000 (G4, High dose recovery) mg/kg body weight/day. Each group consisted of five males and five females.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Known weight of the Stearinsaureanhydrid was moistened with minimum volume of distilled water, so as to prepare a paste. The paste thus prepared was evenly applied to the groups of male and females rats by dermal route applied to the skin on a five days per week basis for 4 weeks. Control group of animals were similarly treated but with distilled water alone.
Examinations
- Observations and examinations performed and frequency:
- The following observations were performed: Mortality/ Viability (Twice daily), Ophthalmoscopy (before start of treatment and towards end of the treatment period), clinical signs (daily), body weights and feed consumption (once weekly), haematology, clinical biochemistry and urine analysis at the end of treatment ( after 4 weeks) and recovery (6 weeks).
At the end of the treatment and recovery period, all animals were weighed, sacrificed and necropsied. Histological examination was performed on all organs and tissues of control and high dose group animals as per the study plan and target organs of low, intermediate as well as in control recovery and high dose recovery groups. Urine samples were collected for analysis and blood was sampled for clinical pathology from all the animals.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs of illness were observed in any of the animals during treatment and recovery period.
- Dermal irritation:
- no effects observed
- Mortality:
- no mortality observed
- Description (incidence):
- Mortality was not observed in any of the animals of the different treatment groups during the study.
No clinical signs of illness were observed in any of the animals during treatment and recovery period. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weights and Body weights gain of male and female of all the treated animals were comparable with the respective control group animals during dosing period of 28 days and recovery period of 14 days.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- During the 28 consecutive days of dosing period and post -dosing recovery period of 14 days the quantity of feed consumed by animals across different dose groups was found to be comparable with that of respective control animals.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- No abnormalities were observed in the ophthalmological examination conducted during
acclimatization and at the end of treatment in the control and high dose group. - Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No treatment-related effect were detected in the measured hematological parameters of treatment and recovery groups compared with respective control groups.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No treatment-related effect were detected in the measured biochemistry parameters of treatment and recovery groups compared with respective control groups.
- Endocrine findings:
- not examined
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related effect were observed either in the group mean values or in the incidence of semi quantitative observations made across different dose groups.
No test item related changes in the urinary parameters were observed in the treatment and recovery
groups compared with respective control groups. - Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No test item related changes were observed in absolute, relative organ weights values of male and
female animals during treatment and recovery period. - Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- There were no treatment related macroscopic findings across different groups of both sexes.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- There were no treatment related microscopic findings across different groups of both sexes.
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- There were no treatment related microscopic findings across different groups of both sexes.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no treatment related effects
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In the present study, No test item related changes in body weight, body weight gain, clinical signs, ophthalmic examination findings, feed consumption and urine analysis were noted. Minor changes in hematological, clinical biochemistry and organ weights were recorded at the end of treatment and recovery periods. But, the variations observed were considered incidental and the respective tissues revealed no abnormalities in macroscopic and histopathological examination. There were no treatment related systemic effects at any dose level. In the light of above observations, the No Observed Adverse Effect Level (NOAEL) of Stearinsaureanhydrid) for Wistar rats via the dermal route could be considered as >1000 mg/kg body weight under the experimental conditions.
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