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EC number: 203-479-6 | CAS number: 107-29-9
- 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:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Old study but very well documented.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- no
- Remarks:
- study performed in 1976
- Limit test:
- no
Test material
- Reference substance name:
- Acetaldehyde oxime
- EC Number:
- 203-479-6
- EC Name:
- Acetaldehyde oxime
- Cas Number:
- 107-29-9
- Molecular formula:
- C2H5NO
- IUPAC Name:
- acetaldehyde oxime
- Details on test material:
- - acetalaldehyde oxime
- Lot No.: 50-4831-30C
- description: clear liquid with an unpleasant odor
- date of receipt: 1976-03-19
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Wilmington, Massachusetts
- Age at study initiation:
- Weight at study initiation:
- Housing: individually in elevated wire mesh cages
- Diet: ad libitum (Purina Laboratory Chow)
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: solutions of the test material were prepared in a vehicle of distilled water on a weight-per-volume basis
The prescribed daily doses were administered by oral intubation in 2 equally divided doses at a total daily volume of 2.0 mL of test solution/kg of body weight. Dosages were adjusted to the weekly individual body weights. - Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Basis:
actual ingested
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- All of the animals were observed daily for mortality, morbidity, and signs of toxic and pharmacologic effect.
CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION: Yes
- Time schedule for examinations: weekly
FOOD EFFICIENCY: No data
OPHTHALMOSCOPIC EXAMINATION: Yes / No / No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at weeks 4, 8 and 13
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 5 rats/sex/group
- Parameters checked: hematocrit, hemoglobin levels, erythrocyte count, total and differential leukocyte counts
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at weeks 4, 8 and 13
- Animals fasted: Yes
- How many animals: 5
- Parameters checked:
at each interval on the same animals: fasting glucose, blood urea nitrogen (BUN), total protein, total bilirubin (BIT), serum glutamic-pyruvic transaminase (SG-PT), alkaline phosphatase and serum electrophoresis
at week 13: serum glutamic-oxaloacetic transaminase (SG-OT), serum albumin, serum sodium, serum potassium, serum chloride, serum calcium and carbon dioxide
Erythrocyte and plasma cholinesterase levels were determined at weeks 4, 8 and 13 on an additional set of 5 rats/sex/group
URINALYSIS: Yes
- Time schedule for collection of urine: at weeks 4, 8 and 13
- performed on pooled samples of 5 rats/sex/group
- Metabolism cages used for collection of urine: No data
- Animals fasted: Yes / No / No data
- Parameters checked at each interval: specific gravity, pH, ketones, total protein, bilirubin and microscopic examination of the sediment.
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- Necropsies were performed on all animals that died during the course of the study and on all surviving rats at week 13. Animals were sacrificied by exsanguination under sodium pentobarbital anesthesia (Diabutal, Diamond Laboratories Inc., Des Moines, Iowa)
Prior to sacrifice, all of the rats were fasted for 24 h and the terminal body weights were recorded. The following organs of each sacrificied rat were weighed and the organ/body ratios determined:
prior to fixation: liver, spleen, heart, kidneys and testes with epididymides
after fixation: thyroids and adrenals
The following tissues of each rat were preserved in 10% neutral buffered formalin: brain, thoracic spinal cord, pituitary, thyroids, adrenals, heart, lungs, spleen, liver, kidneys, stomach, small and large intestines, pancreas, urinary bladder, testes with epididymides and prostate or ovaries and uterus, salivary glands, mesenteric lymph nodes, eyes, nerve with muscle, bone marrow, rib junction and any unusual lesions.
All of the preserved tissues from the control and high-dose animals, and the spleen and liver tissue from all of the low and mid-dose animals sacrificed at week 13 were stained with hematoxylin and eosin and examined microscopically. - Statistics:
- Statistical analyses of the food consumption data, hematology and blood chemistry, terminal body weights, organ weights, and organ/body weight ratios were performed by Bartlett's test for homogeneity of variances and the one-way classification analysis of variances. When differences were noted in the analysis of variances, Scheffe's method for judging all contrasts or Student's t-test were employed. Growth rates were obtained using Rao's technique.
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 specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- CLINICAL OBSERVATIONS AND MORTALITY:
Survival was 100% in all of the male groups and in the control., low- and mid-dose females. 2 high-dose group females died during weeks 3 and 4. Antemortem signs were observed in one of these animals and included: a hunched appearance, thinness, dyspnea, urine stains and anorexia.
No signs of compound-induced toxicity were observed in any of the surviving animals. Findings observed were generally of an incidental nature and were noted at comparable incidences in the treated and the control groups. These included wheezing, stains on the hair coat, chromodacryorrhea, localized alopecia and sores, lacrimation, cloudy, red or pale eyes, and a hunched appearance.
BODY WEIGHT AND FOOD CONSUMPTION:
The mean body weight and food consumption values of the control and the treated groups were generally comparable and no statistically significant differences were noted.
HAEMATOLOGY
CLINICAL CHEMISTRY
URINALYSIS
The results of urinalyses were generally unremarkable.
ORGAN WEIGHTS:
Moderate to marked increase of statistical significance were noted in the absolute and relative thyroid and spleen weights of the mid- and high-dose males and females and in the relative thyroid and spleen weights of the low-dose males. Slight, but statistically significant, elevations were also noted in the relative and/or absolute heart weights of the high-dose males and females and in the relative and/or absolute liver weights of the mid-dose males and high-dose males and females.
GROSS PATHOLOGY:
The following findings were noted in the 2 high-dose females that died. In animal 27912 (died week 3), the pericardial sac and mediastinum were completely distended apparently due to the rupture of a blood vessel into the sac, the lungs were collapsed and dark-red, the liver was dark-red with a granular appearance, the renal medulla was dark-red, and there was a grey uneven zone at the renal cortico-medullary junction. In animal 27900 (died week 4), there was a large amount of dark-pink fluid in the thoracic cavity, the lungs were covered with a thick, yellow, caseous material, the stomach lining was smooth, and the renal cortico-medullary junction was dark-red.
Enlargement and discoloration (dark-red) of the spleen were noted in the majority of the male and female mid- and high-dose animals sacrificed at termination. Other findings were incidental in nature and were found at comparable incidence in the control and treated groups.
HISTOPATHOLOGY: NON-NEOPLASTIC:
Compound-related histomorpholic alterations were noted in sections of the spleen and liver from rats of the mid- and high-dose levels. Alterations noted in the spleen consisted of increased extramedullary hematopoiesis, increased amounts of greenish-brown pigment in fixed macrophages, and congestion in the red pulp. Sections of spleen from the low-dose male and female rats were comparable in appearance to the control group. Liver sections from male and female rats in the mid- and high-dose groups revealed greenish-brown pigment in Kupffer cells and/or bile canaliculi.
Spontaneous disease and incidental lesions were noted in rats of the control and high-dose groups as follows. Microcysts were noted in the pituitary glands of 3 treated rats. Focal nonsuppurative adrenalitis was present in a single male treated rat. Focal nonsuppurative myocarditis was noted in heart sections of 17 control and 14 treated rats. In addition, fibrinopurulent pericarditis was noted in the 2 high-dose female rats that died (Nos. 27900 and 27912). Fibrinopurulent pleuritis was also present in treated female 27900. Lung sections of control and treated rats contained early lesions of chronic respiratory disease consisting of peribronchial and perivascular lymphoid hyperplasia with occasional small foci of pneumonitis occuring with comparable incidence and severity in the male and female control and treated rats.
Spontaneous disease lesions in the liver sections were principally microgranulomas that were present in liver sections from nearly all rats and minimal to slight nonsuppurative pericholangitis. Focal hepatic necrosis was noted in the liver of treated female 27912 and was possibly associated with a severe fibrinopurulent pleuritis noted in this animal.
Early chronic interstitial nephritis was noted principally in the male rats and was comparable in incidence and severity in the control and treated groups. Nonsuppurative pyelitis was present in the kidney of treated female 27908. Kidney sections from the female rats revealed occasional foci of mineralization at the cortical medullary junction and in the renal medulla, and microcalculi were present in the renal pelvis in a single control female and treated male.
Sections of the gastrointestinal tract were not remarkable except for the presence of nematode parasites in the large intestine of 12 control and 9 treated rats. Sections of pancreas revealed early nonsuppurative pancreatitis in 4 control and 6 treated rats along with lobular atrophy in 2 of the control rats. Sections of the gonads were not remarkable except for hypospermatogenesis in 2 control rats (Nos. 27736 and 27740) and in 4 treated rats (Nos. 27881, 27887, 27889 and 27898). Focal nonsuppurative prostatitis was noted in 2 control rats and a single treated rat. A sperm granuloma was present in the epididymis of control rat 27740. Sections of uterus from control and treated rats revealed hydrometra in comparable numbers of control and treated rats and occasional rats with early cystic endometrial hyperplasia.
Focal nonsuppurative sialoadenitis was present in the salivary glands of 2 control and 2 treated rats and lymphoreticular cell proliferation was present in the cervical lymph nodes in occasional control and treated rats apparently as a result of viral sialoadenitis. Anterior synechia was noted in the eye section of one treated male rat (No. 27876).
Effect levels
- Basis for effect level:
- other: No NOAEL was established in this study.
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified (migrated information)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In conclusion, acetaldehyde oxime, administered to rats for 13 weeks at levels of 25, 75 and 225 mg/kg/day produced an apparent effect upon red blood cells, causing increased destruction of these cells. Resultant effects included decreased hemogram values, several altered serum biochemistry parameters, increased absolute and relative spleen, liver, and thyroid weights, and histopathological alterations indicative of increased red cell turnover.
Although the effects noted, at the lowest dose (25 mg/kg/day) level were marginal and less frequent, on the basis of the results of this study, a definite "no-effect" level has not been established. - Executive summary:
The test material, acetaldehyde oxime, was evaluated for toxicological effects in cesarean-derived albino rats (25/sex/group) when administered orally for 13 weeks at levels of 25, 75 and 225 mg/kg/day (Groups 2, 3 and 4 respectively). A fourth group of animals (Group 1, 25/sex) was similarly treated with the vehicle (distilled water) and served as the control group.
The criteria evaluated for compound effect were clinical signs, mortality, body weight, food consumption, clinical laboratory data, organ weights, and organ/body weight ratios, and gross and microscopic pathology.
No effects attributable to the ingestion of acetaldehyde oxime were noted in evaluations of mortality rates, appearance and behavior, body weight and consumption values, or urinalysis values.
Analyses of the hematology values revealed dose-related decreases in the hematocrit and hemoglobin levels and erythrocyte counts in animals of all the treated groups. These differences were generally marginal in the low-dose group and statistically significant in the high-dose group. Analyses of the clinical chemistry data revealed statistically significant elevations in the total bilirubin levels of the high-dose males and females at week 13, and slight to statistically significant increases in the blood urea nitrogen, plasma cholinesterase, and erythrocyte cholinesterase levels of the mid- and high-dose males and females at most of the intervals. Decreases were also noted in the glucose levels of the high-dose males and females at week 13.
Slight to marked increases were found in the absolute and/or relative thyroid and spleen weights of the low-, mid- and high-dose males and females. Increases were also noted in the absolute and/or relative heart and liver weights of the mid- and high-dose males and females.
Gross alterations (enlargement and discoloration) were noted in the spleens of most of the male and female mid- and high-dose animals sacrificed at termination.
Microscopic evaluations of tissue sections revealed compound-related histomorphological alterations in the mid- and high-dose (75 and 225 mg/kg/day) males and females. These alterations consisted of congestion, increased pigment, and extramedullary hematopoieses in the spleen, and the presence of greenish-brown pigment in the Kupffer cells and the bile canaliculi of the liver. No compound-related effects were observed in the spleen and liver sections of the low-dose males and females.
In conclusion, acetaldehyde oxime, administered to rats for 13 weeks at levels of 25, 75 and 225 mg/kg/day produced an apparent effect upon red blood cells, causing increased destruction of these cells. Resultant effects included decreased hemogram values, several altered serum biochemistry parameters, increased absolute and relative spleen, liver, and thyroid weights, and histopathological alterations indicative of increased red cell turnover.
Although the effects noted, at the lowest dose (25 mg/kg/day) level were marginal and less frequent, on the basis of the results of this study, a definite "no-effect" level has not been established.
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