Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 807-157-1 | CAS number: 129677-93-6
- 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:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- test substance purity not specified, limited documentation, no ophthalmoscopic and neurobehavioural examination
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- test substance purity not specified, no ophthalmoscopic and neurobehavioural examination
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Hexyl laurate
- EC Number:
- 251-932-1
- EC Name:
- Hexyl laurate
- Cas Number:
- 34316-64-8
- Molecular formula:
- C18H36O2
- IUPAC Name:
- hexyl laurate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 180 - 250 g
- Housing: The animals were kept in groups of 2 per cage (Makrolon III)
- Diet: The diet was offered via automatic feeding systems, Altromin R (powder), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24
- Humidity (%): 50 - 60
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The mixtures were newly prepared each week. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 16 weeks
- Frequency of treatment:
- daily, 7 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 10 000 ppm
- Remarks:
- nominal in diet
- Dose / conc.:
- 800 mg/kg bw/day (nominal)
- Remarks:
- Mean dose value as calculated using an approximate diet conversion factor for rats of 10 for young animals (1-10 weeks in the present study) and of 20 for old animals (11-16 weeks in the present study). No data on food intake available.
- No. of animals per sex per dose:
- 10
- Control animals:
- other: liquefied margarine was added to the food
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Before and on completion of administration
BODY WEIGHT: Yes
- Time schedule for examinations: twice per week
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Time schedule: twice per week
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE: Yes
- Time schedule for examinations: twice per week
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Before and on completion of administration
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: All animals
- Parameters examined: hemoglobin, red and white blood corpuscle count and differential blood picture count
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Before and on completion of administration
- Animals fasted: No data
- How many animals: All animals
- Parameters examined: glucose, albumin, calcium, urea, Serum Glutamate Oxalacetate Transaminase (SGOT) Serum Glutamate Pyruvate Transaminase.
URINALYSIS: Yes
- Time schedule for collection of urine: Before and on completion of administration
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters examined: pH value, specific gravity, glucose, protein, albumin, hemoglobin, bilirubin, ketone bodies, sediment.
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, at the end of the test, all animals were dissected, with a macroscopic assessment of the internal organs, these being weighed and preserved for histological investigations.
ORGAN WEIGHTS: Yes, liver, kidney, adrenal glands, spleen, testicles, heart, lungs, thyroid gland, thymus, brain, ovaries.
HISTOPATHOLOGY: Yes, the organs (paraffin sections) were stained with haematoxylin and eosin, with the exception of the brain which, according to Nissl, together with the liver, was stained not only with haematoxylin and eosin but also with Sudan III (frozen sections). The following organs were analyzed: the brain (the cerebrum, the cerebellum), the salivary gland, the thyroid gland with the parathyroid glands, the heart, the lungs, the liver, the spleen, the abdominal salivary gland, the gastro-intestinal tract, the lymph nodes, the kidneys, the suprarenals and reproductive glands, and in the female animals, the uterus.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- non adverse
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
During the period of application and at the end of the test, all animals were free of symptoms.
BODY WEIGHT AND WEIGHT GAIN
The body weights increased steadily and were comparable to the body weights of the control animals.
HAEMATOLOGY
No deviations in comparison with the control animals.
CLINICAL CHEMISTRY
No deviations in comparison with the control animals.
URINALYSIS
No deviations in comparison with the control animals.
ORGAN WEIGHTS
Organ weights were within the normal range.
GROSS PATHOLOGY
Under macroscopic examination, dissection revealed some small, limited pneumonic foci in some of the experimental animals and also in some of the controls. Apart from this, there were no findings of note in the macroscopic examinations.
HISTOPATHOLOGY: NON-NEOPLASTIC
The Kupffer cells in the liver were more adipose in some of the experimental animals than among the controls. The liver cells also showed an increased eosinophilia of certain cells in some of the experimental animals. The remaining organs showed the customary histological pictures for adult rats, consisting of bronchiolitis, slight alterations in the lung structure, varying activity of the thyroid glands, hemosiderosis of the spleen, milky albumen in the uriniferous tubules, slight inflammation of the bowel and occasionally marked sinus catarrh of the mesenteric lymph nodes.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 800 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: clinical observations, body weight gains, appearance of the feces, hematology, clinical chemistry, urinalysis, organ weights, histopathology
- Remarks on result:
- other: highest dose tested
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The test substance is not considered to be toxic after repeated oral exposure. Changes in the liver and lung frequently occur in untreated ageing animals of both sexes and therefore, are not considered as adverse effects.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.