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EC number: 278-636-5 | CAS number: 77182-82-2
- 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
Immunotoxicity
Administrative data
- Endpoint:
- immunotoxicity: short-term oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct - Dec 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.7800
- Version / remarks:
- Aug 1998
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Ammonium 2-amino-4-(hydroxymethylphosphinyl)butyrate
- EC Number:
- 278-636-5
- EC Name:
- Ammonium 2-amino-4-(hydroxymethylphosphinyl)butyrate
- Cas Number:
- 77182-82-2
- Molecular formula:
- C5H12NO4P.H3N
- IUPAC Name:
- ammonium 2-amino-4-[hydroxy(methyl)phosphoryl]butanoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Rj:WI (IOPS HAN)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: R. Janvier, Le Genest St Isle, France
- Age at study initiation: 7 weeks
- Weight at study initiation: 220 g to 263 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 12 days
DETAILS OF FOOD AND WATER QUALITY:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 (light: 7 am to 7 pm)
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- - Reason for choice of route: The oral route (admixture with diet) was selected as it is an accepted route of exposure by regulatory authorities and since it is a possible route of human exposure.
DIET PREPARATION
- Rate of preparation of diet (frequency): not specified
- Mixing appropriate amounts with (Type of food): Certified rodent powdered and irradiated diet A04CP1-10 from S.A.F.E. (Scientific Animal Food and Engineering, Augy, France)
- Storage temperature of food: -18 degrees celsius
: - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The homogeneity of the test substance in diet was verified before the study for the lowest and highest concentrations to demonstrate adequate formulation procedures. The mean value obtained from the homogeneity check was taken as measured concentration. Dietary level of the test substance was also verified for the intermediate concentration.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- continuous
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 ppm (nominal)
- Remarks:
- (equating approximately to 36.4 mg/kg bw/day of the test substance)
- Dose / conc.:
- 2 000 ppm (nominal)
- Remarks:
- (equating approximately to 147 mg/kg bw/day of the test substance)
- Dose / conc.:
- 6 000 ppm (nominal)
- Remarks:
- (equating approximately to 428 mg/kg bw/day of the test substance)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: The dose levels were set after evaluation of the results of previous toxicity studies with this substance. The dietary levels selected for this 28-day immunotoxicity study were 0, 500, 2000 and 6000 ppm.
- Rationale for selecting satellite groups:
- Post-exposure recovery period in satellite groups:
- Rationale for animal assignment (if not random): random
- Reason for selection of species and gender: There is no evidence of immunotoxicity with the test substance in rats or mice. Therefore, the selection of species and gender for the immunotoxicity study is based on which one is more sensitive to the compound using other toxicologic endpoints. In the existing toxicology database, No Observed Adverse Effect Levels (NOAEL’s) for male Wistar rats in repeated oral exposure studies are generally lower than those for both sexes of mice or female rats. Thus, male Wistar rat is selected as the species and gender for immunotoxicity testing.
Examinations
- Observations and clinical examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least once daily
- Cage side observations checked: mortality and clinical signs
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once during acclimatization and at least weekly thereafter
BODY WEIGHT: Yes
- Time schedule for examinations: Once weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yess
- Time schedule: Once weekly
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
OPHTHALMOSCOPIC EXAMINATION: No
IMMUNOLOGY: Yes
- Time schedule for collection of blood: On Day 30
- Anaesthetic used for blood collection: Yes (by inhalation of Isoflurane)
- Animals fasted: No
- How many animals: all animals
- Parameters checked: the level of SRBC-specific immunoglobulin M in response to antigen administration.
CLINICAL CHEMISTRY: No
URINALYSIS: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, examination of all major organs, tissues and body cavities. Selected organs were weighed (spleen and thymus)
- Time of termination: On day 30
HISTOPATHOLOGY: No - Cell viabilities:
- SPLEEN: No
THYMUS: No
BONE MARROW: No - Humoral immunity examinations:
- ANTIBODY PLAQUE FORMING CELLS (PFC) ASSAY: No
ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA): Yes
- Method: Sheep Red Blood Cell (SRBC) Sensitization
- Dose groups: all dose groups
- No. of animals: all animals - Specific cell-mediated immunity:
- ONE-WAY MIXED LYMPHOCYTE CULTURE (MLC) ASSAY: No
DELAYED-TYPE HYPERSENSITIVITY (DTH) REACTION: No
CYTOTOXIC T-LYMPHOCYTE (CTL) ASSAY: No
- Non-specific cell-mediated immunity:
- NATURAL KILLER (NK) CELL ACTIVITY: No
MACROPHAGE NUMBER AND FUNCTION: No - Positive control:
- Cyclophosphamide at 3.5 mg/kg bw/day. Cyclophosphamide, a known immunosuppressive agent (batch number 068K1131: a white powder, 98.0% purity) was used throughout the study. Information on the chemical characterization of cyclophosphamide was documented by the supplier Sigma-Aldrich, USA. Cyclophosphamide was stored in an air-tight, light-resistant container at +5°C (±3°C).
- Statistics:
- F-test, modified t-test, t-test, Bartlett test, ANOVA, Kruskal-Wallis, Dunnett, Dunn, Mann-Whitney
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- - 6000 ppm: Piloerection and ocular discharge between Days 17 and 29 and wasted appearance between study Days 17 and 22 in a single male rat.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- - 6000 ppm: Mean body weight was reduced by 6 to 7% throughout the study (p≤0.01 on study Days 8 and 15). This effect was attributable to a reduced mean body weight gain between study Days 1 and 8 (28 g compared to a gain of 49 g in the controls; p≤0.01). Thereafter, mean body weight gain per day was similar to the controls.
- 2000 ppm: mean body weight was reduced by 5 to 6% throughout the study (not statistically significant). This effect was attributable to a slightly reduced mean body weight gain between study Days 1 and 8 (37 g compared to a gain of 49 g in the controls; p≤0.01). Thereafter, mean body weight gain per day was similar to the controls.
- 500 ppm: Mean body weight was reduced by 3 to 4% throughout the study (not statistically significant). This effect was attributable to a slightly reduced mean body weight gain between study Days 1 and 8 (39 g compared to a gain of 49 g in the controls; p≤0.01). Thereafter, mean body weight gain per day was similar to the controls. - Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- - 6000 ppm: Mean food consumption/day was reduced by 19 and 10% on study Days 8 and 15, respectively (p≤0.01), and was similar to the control group afterwards.
- 2000 ppm: Mean food consumption/day was slightly reduced by 12% (p≤0.01) during the first week of treatment in comparison to the control group and was unaffected afterwards.
- 500 ppm: Mean food consumption/day was slightly reduced by 9% (p≤0.01) during the first week of treatment in comparison to the control group and was unaffected afterwards. - Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- no effects observed
- Description (incidence and severity):
- There was no treatment-related change in the level of SRBC-specific IgM present in the blood 4 days after intravenous injection of SRBC up to 6000 ppm.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- There were no changes in mean organ weights when compared to the controls.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- - 6000 ppm: Pelvic dilatation in the kidney was observed in 4/10 animals.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Specific immunotoxic examinations
- Cell viabilities:
- not examined
- Humoral immunity examinations:
- no effects observed
- Description (incidence and severity):
- There was no treatment-related change noted in anti-SRBC IgM concentrations up to 6000 ppm.
- Specific cell-mediated immunity:
- not examined
- Non-specific cell-mediated immunity:
- not examined
- Other functional activity assays:
- not examined
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 6 000 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- immunology
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Compared to controls, no impairment of the immunological IgM response following immunization with SRBC was observed in male Wistar rats treated with glufosinate-ammonium in the diet at dose levels up to 6000 ppm for at least 28 days (corresponding to 428 mg/kg body weight/day). Therefore, glufosinate-ammonium was considered not to have any immunotoxic potential.
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