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EC number: 227-824-5 | CAS number: 5994-61-6
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study summary presented, conduct of study meets generally accepted scientific principles, acceptable for assessment.
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
- Principles of method if other than guideline:
- Test material is administered to mated animals from Day 6 to15 of gestation. On Gestation Day 20, all surviving females are killed, the uterine contents are examined, and the fetuses are evaluated for soft tissue and skeletal changes.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- N-(carboxymethyl)-N-(phosphonomethyl)glycine
- EC Number:
- 227-824-5
- EC Name:
- N-(carboxymethyl)-N-(phosphonomethyl)glycine
- Cas Number:
- 5994-61-6
- Molecular formula:
- C5H10NO7P
- IUPAC Name:
- 2-[(carboxymethyl)(phosphonomethyl)amino]acetic acid
- Details on test material:
- - Name of test material (as cited in study report): Glyphosate intermediate
- Lot/batch No.: LC-lG-01-002
- Purity: 96.86 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River COBS® CD®
- Details on test animals or test system and environmental conditions:
- Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- Not reported
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not applicable
- Details on mating procedure:
- Not reported
- Duration of treatment / exposure:
- Day 6 to 15 of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- 20 d
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 25, 100 and 400 mg/kg/day
Basis:
actual ingested
dose volume 10 mL/kg
- No. of animals per sex per dose:
- Twenty five
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not reported
Examinations
- Maternal examinations:
- MORTALITY: Yes
- Time schedule: Twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once daily
BODY WEIGHT: Yes
- Time schedule for examinations: On gestation Days 0, 6, 9, 12, 16 and 20
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Time schedule: On Days 6, 9, 12, 16 and 20
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation Day 20
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - Number and location of viable and nonviable fetuses: Yes
- External examinations: Yes
- Soft tissue examinations: Yes
- Skeletal examinations: Yes - Statistics:
- Not reported
- Indices:
- Not reported
- Historical control data:
- Not reported
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Mortality: Six of 25 dams in the high dose group died between Gestation Days 15 and 19. There was no mortality in any of the other treatment groups or control.
Clinical signs: Clinical signs of toxicity observed included yellow, brown or red matting of the fur, soft stools, hair loss and emaciation. These signs were predominantly seen in those animals which died during the study.
Body weight and food consumption: Body weight loss, decreases in body weight gain and decreases in food consumption were observed in animals of the high-dose group during the period of dosing. After the dosing period, body weight gain and food consumption were comparable to the control group.
Necropsy examination: Approximately 91 % of the surviving treatment and control animals showed no gross signs of toxicity at the terminal necropsy examination. The few observations noted included kidney hydronephrosis, pale livers and distended ureters. No treatment related toxicity was evident. The number of viable fetuses, postimplantation loss, total implantations and the number of corpora lutea per dam revealed no treatment-related effects.
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Body weight: The mean fetal body weight in the high dose group was slightly reduced (~9 %) when compared with control. This fetotoxic response was considered to be related to the maternal toxicity observed in the high-dose group.
Malformations: The total number of malformations and the total number of fetuses with malformations increased in a dose related manner. However, the total number of litters with malformations were not increased. None of the malformations were observed at abnormal litter or fetal frequencies. All malformations observed commonly occur in fetal rats and were within the historical control range. An occurrence of bent ribs were observed to be slightly increased at the high dose level. But this finding was not considered to be treatment related.
A similar pattern of increased total numbers of genetic and developmental variations was observed in the mid and high dose groups. They were considered to be related to maternal toxicity rather than a teratogenic response.
Effect levels (fetuses)
- Dose descriptor:
- NOEL
- Effect level:
- 400 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Exposure to the test material at 25, 100 and 400 mg/kg/day resulted in significant maternal toxicity at the high dose group and signs of fetotoxicity
were observed in the high- and mid-dose groups. Although the total number of fetuses with malformations increased in a dose-related manner, none of the malformations were observed at abnormal litter or fetal frequencies. Under the conditions of the test, the teratogenic no observed effect level (NOEL) was considered to be 400 mg/kg/day. - Executive summary:
A study was conducted to evaluate the teratogenic potential of test material in Charles River COBS® CD® female albino rats.
Test material in 0.5 % carboxymethyl cellulose was administered via oral gavage to three groups of 25 mated animals at concentrations of 0, 25, 100 and 400 mg/kg/day from Days 6 to15 of gestation. All surviving animals were sacrificed on gestation Day 20.
Significant maternal toxicity was observed in the high dose (400 mg/kg/day) group. Body weight loss, decreases in body weight gain and decreases in food consumption were observed in animals of the high dose group animals during the period of dosing. Examination of the reproductive parameters, i.e. viable fetuses, postimplantation loss, total implantations and the number of corpora lutea per dam revealed no treatment-related effects. The total number of malformations and the total number of fetuses with malformations increased in a dose-related manner. However, none of the malformations were observed at abnormal litter or fetal frequencies.
Under the conditions of the test, the teratogenic no observed effect level (NOEL) was considered to be 400 mg/kg/day.
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