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EC number: 947-890-5 | 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: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Not GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Amides, C12-18(even-numbered) and C18(unsatd.), N-hydroxyethyl
- EC Number:
- 931-338-5
- Molecular formula:
- not applicable
- IUPAC Name:
- Amides, C12-18(even-numbered) and C18(unsatd.), N-hydroxyethyl
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Comperlan 100 (CAS no. 90622-77-8)
- Physical state: Waxy material with a slightly fatty odor
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mus-Rattus, Brunntal, Germany
- Age at study initiation: between 6-7 wk
- Weight at study initiation: 111 (f) - 125 (m) g
- Housing: plastic cages, 3 males and 5 females/cage
- Diet (e.g. ad libitum): ad libitum (Altromin Ratdiet No. 1424 DK, Altromin GmbH, Lage, Germany)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: 6 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20
- Humidity (%): 60-75
- Air changes (per hr): 11
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- doses were adpated weekly to the body weight
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 28 d
- Frequency of treatment:
- daily once, 5 times/wk
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
70 mg/kg bw/d (Days 1-28)
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
250 mg/kg bw/d (Days 1-28)
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
750 mg/kg bw/d (Days 1-14)
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1500 mg/kg bw/d (Days 15-28)
Basis:
actual ingested
- No. of animals per sex per dose:
- 10/sex/dose for main study; 5/sex/dose for 4 month recovery period
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- according to standard procedure
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: end of study
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: end of study
- Anaesthetic used for blood collection: Yes (ether)
- How many animals: 10 per dose and sex
- Parameters checked: Hematocrit, erythrocytes, leukocytes, hemoglobin, thrombocytes, mean corpuscular volume, white blood cell differntial
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: end of study
- How many animals: 10 per sex and dose
- Parameters checked: GPT, GOT, AP, glucose, urea, total protein, calcium, phosphate, cholestrol
URINALYSIS: Yes
- Time schedule for collection of urine: end of study
- Metabolism cages used for collection of urine: No
- Parameters checked: urea, creatinin, sodium, potassium, glucose, calcium, ap
NEUROBEHAVIOURAL EXAMINATION: No
Other: Groups of 5 male and 5 female rats kept for an additional 4 month recovery period. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
the following tissues/organs were examined:
adrenal gland (2)
aorta thoracica
brain (cornu ammonis)
coagulating gland with seminal vesicle
epididymis (2)
eye with optic nerve (2)
heart
intestine, large
intestine, small
kidney (2)
liver
lungs
lymph node (cervical) (1)
lymph node (mesenteric) (1)
mucles
oesophagus
ovary (2)
pancreas
prostate
salivary glands (mandibular,
parotid and sublingual gland)
skin
spleen
stomach
testicle (2)
thymus
thyroid (2) (incl. parathyroids)
tongue
trachea (incl. larynx)
urinary bladder
uterus (incl. cervix and oviducts)
HISTOPATHOLOGY: Yes
see gross pathology - Statistics:
- 't' test used for statistical analysis of all parameters except organ weight (U-test)
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):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- The doses up to 1500 mg/kg bw/d were tolerated by all animals without lethality. The body weight gain and total increase of body weights did not differ from the control group. Absolute and relative organ weights showed no significant changes in the substance groups compared to the control group, accept the organ weight of the adrenal gland which is increased for the females of group 3 (250 mg/kg) and 4 (750/1500 mg/kg bw). This result is considered of no relevance. The pathological, histological evaluation did not show significant compound related gross or microscocopic organ injury of liver, kidneys, adrenals, heart, lung, spleen and gonads; dose independent reversible local findings were restricted to the fore stomach mucose of the highest group (hyperplastic and cellular changes in the forestomach but not dose-related and also found in controls. Attributed to the use of olive oil as carrier. Effects disappeared during 4 month recovery period). The biochemical parameters calcium, blood sugar, urea, creatinine, cholesterine, GGT, GOT, GPT and LDH did not show any irregular signs. Slight alterations of phosphate in the highest group were noted and regarded as dose/compound related but not critical effect.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 750 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: No biologically relevant effects observed on any of the parameters recorded at any dose. Also, test animals treated with 1500 mg/kg bw /d (Day 15-28) showed no adverse effect
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the systemic NOAEL was considered to be >750 mg/kg bw.
- Executive summary:
A study was conducted to determine the repeated dose oral toxicity of the test substance to rats according to a method similar or equivalent to OECD Guideline 407. Groups of 10 male and 10 female rats were orally gavaged with the test substance diluted in olive oil 5 d/wk at 0, 70, 250, 750 (Days 1-14) or 1500 (Days 15-28) for 28 d. Clinical signs, bodyweight, hematology, clinical chemistry, urinalysis, gross and microscopic pathology were recorded. Additional groups of 5 male and 5 female rats were kept for a 4 month recovery period. No treatment-related adverse effects were observed at any of the doses. Changes in the forestomach at some doses including controls were attributed to the use of olive oil and found to be reversible after end of exposure. The doses up to 1500 mg/kg bw/d were tolerated by all animals without lethality. The body weight gain and total increase of body weights did not differ from the control group. The pathological, histological evaluation did not show significant compound related gross or microscopic organ injury of liver, kidneys, adrenals, heart, lung, spleen and gonads. Dose-independent reversible local findings were restricted to the fore stomach mucosa of the highest group. The biochemical parameters calcium, blood sugar, urea, creatinine, cholesterol, GGT, GOT, GPT and LDH did not show any irregular signs. Slight alterations of phosphate in the highest group were noted and regarded as dose/compound related but not critical effect. Hence, under the study conditions, the systemic NOAEL was considered to be >750 mg/kg bw (Gloxhuber, 1983).
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.
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