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EC number: 274-357-8 | CAS number: 70161-44-3
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: 90-day oral toxicity study
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to internationally accepted guidelines.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA OPP 82-1 (90-Day Oral Toxicity)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Sodium N-(hydroxymethyl)glycinate
- EC Number:
- 274-357-8
- EC Name:
- Sodium N-(hydroxymethyl)glycinate
- Cas Number:
- 70161-44-3
- Molecular formula:
- C3H7NO3.Na
- IUPAC Name:
- sodium N-(hydroxymethyl)glycinate
- Details on test material:
- - Name of test material: Suttocide®A, the CTFA Adopted Name of Sodium Hydroxymethylglycinate- Lot/batch No.: Not specified- Purity: Not specified, but analytical studies were carried out over a twelve week period to determine whether 2%-Suttocide A solutions used in the 90 Day Oral Gavage Study at Food and Drug Research Laboratories, Inc. were stable.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:10, 40, 160 mg/kg bwBasis:actual ingested
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE/CLINICAL OBSERVATIONS: Yes - Time schedule: daily two mortality checks five hours apart, once daily for external signs of toxicity- Cage side observations checked in table were included (Appendix III of the study report).BODY WEIGHT and FOOD CONSUMPTION: Yes - Time schedule for examinations: measured prior to initiation of the study (day -1), weekly thereafter, and at the time of necropsy. - Food consumption: measured weekly. - Food efficiency: Yes OPHTHALMOSCOPIC EXAMINATION: Yes - Time schedule for examinations: on all rats prior to initiation of the study and on all rats after 13 weeks of dosing. - The eyes of all rats were examined by indirect ophthalmoscopy after pupil dilation with 1% Tropica-mide. CLINICAL LABORATORY STUDIES: Yes- Blood samples for hematology and clinical chemistry determinations and urine samples for urine analysis were collected after 6 and 13 weeks of dosing from all animals.- Blood was drawn from the periorbi tal plexus (orbital sinus puncture) under light ether anesthesia. - Animals were fasted overnight prior to blood collection.* HAEMATOLOGY: Yes- Parameters: hemoglobin; hematocrit; erythrocyte count; total and differential leucocyte counts platelet count. * CLINICAL CHEMISTRY: Yes- Parameters: urea nitrogen; glutamic pyruvic transaminase (GPT) glutamic oxaloacetic transaminase (GOT) calcium; phosphorus; chloride; sodium; potassium; glucose; total bilirubin; albumin; globulin; total protein ; creatinine * URINALYSIS: Yes - Parameters: appearance; specific gravity; occult blood; protein; pH; bilirubin; urobilinogen; ketones; glucose; microscopic examination of sediment
- Oestrous cyclicity (parental animals):
- Not examined
- Sperm parameters (parental animals):
- Not examined
- Litter observations:
- Not applicable
- Postmortem examinations (parental animals):
- SACRIFICE- Male animals: All surviving animals - Maternal animals: All surviving animals GROSS NECROPSY- Gross necropsy HISTOPATHOLOGY / ORGAN WEIGHTS- Microscopic examination of paraffin embedded hema-toxylin and eosin stained tissue sections (3-5 microns) was performed on the following organs and tissues from all rats in the high dosage and control groups which were sacrificed at termination and from one rat that died during the course of the study: ovaries testes thyroid (both lobes) and parathyroidsadrenal glands liver spleen aorta stomach uterus cerebellular cortexpancreas thymus esophagus pituitary gland brain-medulla/pons heart rectum urinary bladder intestine, small (duodenum, jejunum, ileum) salivary gland (submaxillary) intestine, large (cecum, colon) sciatic nerve all gross lesionkidneys lung with mainstem bronchi lymph node (mesenteric)
- Postmortem examinations (offspring):
- Not applicable
- Statistics:
- Continuous data (body weight, food consumption, clinical parameters, absolute and relative organ weights) were analyzed using analysis of variance (Snedecor and Cochran, 1967). Differences between groups were identified using the Least Significant Difference test. Pathology inci- dence data were analyzed using Fisher's Exact test. For all statistical analyses, significance was juagea at the level of pi 0.05.
- Reproductive indices:
- Not applicable
- Offspring viability indices:
- Not applicable
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 160 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects: clinical signs; mortality; body weight; food consumption; food efficiency; ophthalmoscopic examination; haematology; clinical chemistry; urinalysis; gross pathology; organ weights; histopathology
- Remarks on result:
- other: Generation: juvenile to adult in a 90-day study (migrated information)
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not examined
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not examined
Effect levels (P1)
- Remarks on result:
- not measured/tested
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Effect levels (F1)
- Remarks on result:
- not measured/tested
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Oral administration (via gavage) of Suttocide A for 90 consecutive days to Sprague-Dawley rats at levels of 10, 40 and 160 mg/kg body weight did not result in any significant toxicological or histopathological effects which were treatment related. This includes examination of both testes and uteri of exposed male and female rats, respectively.
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