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EC number: 930-964-6 | 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:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test in compliance with Food and Drug Administration (FDA) and Good Laboratory Practice Regulations (GLP), and all aspects of the chronic studies were subjected to retrospective quality assurance audits.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Food and Drug Administration (FDA) Regulations
- Deviations:
- no
- Principles of method if other than guideline:
- Internal method of International Research and Development Corporation, Mattawan (MI), USA.
- GLP compliance:
- yes
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): monochloroacetic acid
- Physical state: colorless crystalline material
- Analytical purity: 99%
- Lot/batch No.: C035826
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories (portage, MI, USA).
- Age at study initiation: 6 - 7 weeks old.
- Housing: Animals of the same sex were housed in groups of five, in polycarbonate with Edstrom grommets cages (HazIeton System Inc., Aberdeen, MD).
- Diet (e.g. ad libitum): NIH-07 open formula mash diet (Zeigler Bros., Inc., Gardners, PA); ad libitum.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Average temperature: 74.2 ºF
- Average humidity: 38.9 %
- Light: fluorescent, 12 hours/day
- Room air flow: 10-12 changes/hour
IN-LIFE DATES: From: 17.08.1981 To: 16.11.1981
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The dose formulations were prepared by mixing appropriate amounts of monochloroacetic acid and deionized water. Stability studies conducted by the analytical chemistry laboratory and by the study laboratory confirmed the stability of monochloroacetic acid solutions for at least 3 weeks.
During the study, the dose formulations were stored at room temperature for no longer than 2 weeks. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The study laboratory conducted periodic analyses of the monochloroacetic acid dose formulations using gas chromatographic procedures.
- Duration of treatment / exposure:
- 13 weeks (plus an additional day of dosing in week 14).
- Frequency of treatment:
- Daily, five days per week.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
30 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
60 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
90 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
120 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
150 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- Groups of 20 rats of each sex.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Five animals per dose group were designated for interim evaluations after 4 and 8 weeks of chemical administration.
A computerized random number generator randomIy selected the animals for use. A computerized sort produced a listing of the animals by ascending body weight per sex. Blocks were arranged by weight, and the animals were then assigned to groups by sets of random numbers. - Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- Animals were observed twice daily for morbidity and mortality and were given physical examinations weekly (twice during week 1).
Animals were weighed prior to the first dosage and individual animal weights were recorded on a weekly basis and at interim evaluations and at the end of the studies.
Blood and urine were collected from 5 rats in each dose group (fewer in the highest dose group due to mortality) at weeks 4 and 8 and from all surviving animals at the end of the studies. - Sacrifice and pathology:
- Moribund animals were killed and necropsied.
After 13 weeks, all surviving animals were killed, and a complete necropsy was performed. Organ weights were determined for the liver, right kidney, adrenal gland, brain, heart, thymus and lungs of all animals and the right testis of all males. Histopathology was performed on all rats dying before the end of the studies and all rats in the control, 60, 90, 120, and 150 mg/kg dose groups. The heart, liver, and lungs from rats in the 30 mg/kg group were also examined. - Statistics:
- Dunn's or Shirley's test.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- All rats receiving 120 or 150 mg/kg monochloroacetic acid, and all but one receiving 90 mg/kg, died before the end of the study. Other deaths included two male rats and one female rat receiving 60 mg/kg and one female rat receiving 30 mg/kg.
The mean body weights of dosed animals that survived to the end of the studies were similar to those of the controls.
Absolute and relative heart weights of males and females receiving 60 mg/kg were significantly lower than control values; relative heart weight was also decreased in females receiving 30 mg/kg. Relative liver weights of males and females that received 60 mg/kg were significantly greater than the control values, but absolute liver weights were significantly increased only in males. Relative, but not absolute, kidney weights were increased in males receiving 60 mg/kg.
A significant, dose-related increase in blood urea nitrogen occured in male rats receiving 90 to 150 mg/kg and in female rats receiving 60 to 150 mg/kg. Significant dose-related increases in alanine aminotransferase and aspartate aminotransferase levels were observed in male and female rats receiving 60, 120, or 150 mg/kg.
Cholinesterase levels were significantly lower than that of controls in male rats receiving 90 mg/kg for 8 weeks and in male rats receiving 30 or 60 mg/kg for 13 weeks.
Levels of thyroxin (T4) were significantly higher than those of controls in male rats receiving 90, 120 or 150 mg/kg for 4 weeks, and in males receiving 90 mg/kg for 8 weeks.
Hematocrit, hemoglobin and erythrocyte counts for male rats that received 150 mg/kg were significantly higher than control values after 4 weeks of compound administration.
Chemical-related degenerative and inflammatory changes (cardiomyopathy) were observed microscopically in the hearts of male and female rats receiving 60,90, 120, or 150 mg/kg. Acute or subacute cardiomyopathy was observed in rats that died during the studies after receiving 60, 90, 120 or 150 mg/kg and was considered to be the cause of death. The most extensive and severe lesions occured in rats surviving several days or weeks after treatment was initiated.
Effect levels
- Dose descriptor:
- NOAEL
- Sex:
- male/female
- Basis for effect level:
- other: changes in heart, liver and kidney weights, clinical chemistry values and mortality; at doses ≥60 mg/kg bw/day cardiopathy was observed.
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Doses (mg/kg bw) | Dead animals/Exposed animals |
MALES | |
0 | 0/10 |
30 | 0/10 |
60 | 2/10 |
90 | 9/10 |
120 | 13/13 |
150 | 15/15 |
FEMALES | |
0 | 0/10 |
30 | 1/10 |
60 | 1/10 |
90 | 10/10 |
120 | 15/15 |
150 | 17/17 |
Applicant's summary and conclusion
- Conclusions:
- Compound-related deaths occurred in the three highest dose groups (all males given 120 or 150 mg/kg bw/day, 9/10 males given 90 mg/kg bw/day, and a 11 females given 90 to 150 mg/kg bw/day). Final mean body weights of surviving rats receiving monochloroacetic acid were similar to those of controls. In rats, dose-related increases in blood urea nitrogen, alanine aminotransferase, and aspartate aminotransferase levels were observed, and relative liver and kidney weights were elevated. A dose-related increase in the incidence and severity of cardiomyopathy was observed in male and female rats receiving monochloroacetic acid.
- Executive summary:
A toxicology study was conducted by administering monochloroacetic acid in deionized water by gavage to groups of F344/N rats of each sex once daily, 5 days per week for 13 weeks.Groups of 20 rats of each sex received 0,30, 60, 90, 120 or 150 mg/kg bw /day. Five animals in each dose group were killed at weeks 4 and 8 for the evaluation of haematology parameters.
Animals were observed twice daily for morbidity and mortality and were given physical examinations weekly (twice during week 1). Animals were weighed prior to the first dosage and individual animal weights were recorded on a weekly basis and at interim evaluations and at the end of the studies. Blood and urine were collected from 5 rats in each dose group (fewer in the highest dose group due to mortality) at weeks 4 and 8 and from all surviving animals at the end of the studies.
Moribund animals were killed and necropsied. After 13 weeks, all surviving animals were killed, and a complete necropsy was performed. Organ weights were determined for the liver, right kidney, adrenal gland, brain, heart, thymus and lungs of all animals and the right testis of all males. Histopathology was performed on all rats dying before the end of the studies and all rats in the control, 60, 90, 120, and 150 mg/kg bw /day dose groups. The heart, liver, and lungs from rats in the 30 mg/kg bw /day group were also examined.
Compound-related deaths occurred in the three highest dose groups (all males given 120 or 150 mg/kg bw /day, 9/10 males given 90 mg/kg bw /day, and a 11 females given 90 to 150 mg/kg bw /day). Final mean body weights of surviving rats receiving monochloroacetic acid were similar to those of controls. In rats, dose-related increases in blood urea nitrogen, alanine aminotransferase, and aspartate aminotransferase levels were observed, and relative liver and kidney weights were elevated. A dose-related increase in the incidence and severity of cardiomyopathy was observed in male and female rats receiving monochloroacetic acid.
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