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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: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- 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 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
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
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentrations of the test item in the exposure chamber were analyzed by collecting samples at 2,
4 and 6 hours after chamber equilibrium time during the exposure period. Samples in triplicate were taken for each time point for dose concentration analysis. The chamber concentration analysis was performed once a week (on days 1, 8, 15, 22). - Duration of treatment / exposure:
- up to 28 days (4 Weeks)
- Frequency of treatment:
- 6 hours exposure daily, 5 days a week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/L air
- Remarks:
- Control group
- Dose / conc.:
- 0.6 mg/L air (nominal)
- Dose / conc.:
- 1.2 mg/L air
- Dose / conc.:
- 2.4 mg/L air
- Remarks:
- including recovery group
- No. of animals per sex per dose:
- 5 males, 5 females for each group
- Control animals:
- yes, concurrent no treatment
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 male and female animals of main study treated concentration of 0.60, 1.20 and 2.40 mg/L.
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality was observed in any of the male and female animals of main study treated with test item concentration of 0.60, 1.20 and 2.40 mg/L throughout the experimental period.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No adverse effect on body weight and body weight gain (%) was observed for treated groups when
compared with vehicle control group. The changes observed were within the historical background
range with respect to age and sex of the animals. - Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No adverse effects on food consumption were observed in treated group animals when compared with control group animals.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Hematology parameters viz Erythrocyte count (RBC), Hemoglobin (Hb), Hematocrit (PCV), Mean
corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), White blood cell count (WBC), Differential Counts (Neutrophils, basophils and Lymphocytes), Reticulocyte, platelets, APTT and Prothrombin time (PT) did not show any
toxicologically relevant findings in both the sexes of treatment group and females of recovery group.
At week 6, reticulocyte count and basophils were found to be increased in high dose (G4R) when compared with control (G1R) in males.
The significant changes observed in the hematological parameters are marginal and could not be
attributed to the test item administration as these values were within clinical and biological variation. - Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Clinical biochemistry parameters viz Blood Urea Nitrogen, Creatinine, Cholesterol, Triglycerides,
Alkaline phosphatase (ALP), Bilirubin total, Sodium (Na), Chloride (CO, Calcium (Ca), Protein,
Albumin, Globulin and A/G Ratio did not show any toxicologically relevant findings in males of
treatment group. There is no toxicologically relevant findings except glucose (GLU) in males of
recovery group. There is no toxicologically relevant findings in females of recovery group
Week 4 analyses showed statistically increased glucose (GLU) levels in intermediate dose group (G3) and high dose group (G4) when compared with control group (G1) for males. Increased Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) levels in intermediate dose group (G3) whereas increased Phosphorus (PHOS) and Potassium (K) levels in high dose group (G4) when compared with control group (G1) for males. In females, decreased glucose (GLU) and Increased Phosphorus (PHOS) levels were observed in intermediate dose group (G3) and high dose group (G4) when compared with control group (01). Increased Calcium (Ca) levels in low dose group (G2) and high dose group (G4) in females) when compared with control group (G1). Increased Globulin (GLB) levels in intermediate dose group (G3) when compared with control group (G1).
Even though there is statistical significance observed, these changes may not be biologically significant since all the values were well within the normal biological range. - Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- 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):
- There were no treatment related changes in terminal fasting body weight and organ weights in any of
the treatment groups when compared to vehicle control.
In main group males, there was increase in absolute and relative weight of liver in group 3 when
compared to control. In recovery group male animals, increase in absolute and relative weight of
adrenal and decrease in absolute and relative weight of thymus was observed in group 4R when compared to the corresponding control group. These changes were considered incidental in the absence of similar weight changes in the main group high dose (Group 4) animals.
In females, increase in absolute weight of brain in group 3 and 4 when compared to control group was
considered incidental as there was no changes in the relative organ weights for these organs. In recovery group female animals, decrease in absolute and relative weight of spleen was observed in
group 4R when compared to the corresponding control group. These changes were considered
incidental as there were no weight changes observed at main group high dose animals when compared to control. - Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment related gross findings in males and females.
Single incidence of unilateral small sized testes was observed in group 1 male animal (Animal No.
04). Microscopically, atrophy of seminiferous tubules in testes of moderate severity was observed and
was considered incidental. In animal No. 28 of group 3, dark red discoloration in liver, enlarged spleen and dilated heart was observed. Microscopically, congestion with moderate and minimal severity was observed in liver and spleen respectively and heart showed moderately dilated right auricle and ventricle. Congestion in liver and spleen may be attributed to right sided heart failure. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment related histopathological findings attributable to the test item in any tissues of
high dose (2.40 mg/L) group animals of both sexes.
One or two incidence of microscopic findings observed in liver, lungs, testes, epididymides and larynx were considered incidental as they were common background findings observed in the species. - Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- >= 2.4 mg/L air (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no treatment-related effects were observed
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 2.4 mg/L air (nominal)
- System:
- other: no treatment-related effects were observed
Applicant's summary and conclusion
- Conclusions:
- Stearinsaureanhydrid was exposed daily to group of Wistar rats for a period of 22 days at doses of 0.6, 1.2 and 2.4 mg/L. No test item related changes in the body weights, feed consumption, haematology and organ weights were observed. Macroscopic and microscopic examination revealed no abnormality attributable to the treatment at the highest dose (2.4 mg/L). In the absence of gross and histopathological findings in the organs and due to negligible change in the profile of animals of high dose (G4) high dose is considered to have low observed effect. Hence, under the conditions of the experiment and based on the findings of the present study entitled "Acute Inhalation Toxicity Study in Rats with Stearinsaureanhydrid", the No Observed Adverse Effect Concentration (NOAEC) was found to be the highest dose level employed, i.e. 2.40 mg/L.
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