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Diss Factsheets
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EC number: 200-274-3 | CAS number: 56-45-1
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented study similar to OECD guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Beijing Weitonglihua experimental animal technique Co. Ltd
- Age at study initiation: 6 weeks
- Housing: 5 animals were housed in a bottom-meshed stainless cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-22°C
- Humidity (%): 40-70%
- Air changes (per hr): ~15 changes/h
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- individual dose volume of 10 ml/kg was calculated according to the latest measured body weight.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- test article was administered daily by gavage
- Remarks:
- Doses / Concentrations:
500, 1500, 3000 mg/kg bw
Basis:
actual ingested - No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes
- Positive control:
- no
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: twice a week
FOOD CONSUMPTION: Yes
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at the end of the experimental period
- Anaesthetic used for blood collection: Yes (phenobarbital sodium)
- Animals fasted: Yes
- Parameters checked: RBC, HGB, HCT, MCV, MCH, MCHC, WBC, PLT, differential counts of leukocytes, reticulocyte count
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at the end of the experimental period
- Animals fasted: Yes
- Parameters checked: TP, ALB, GLU, T-CHO, TG, T-BIL, BUN, CRE, IP, AST, ALT, ALP, Na, K, Cl, Ca
URINALYSIS: Yes
- Time schedule for collection of urine: during the last 4 days of the administration period
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters checked: urobilinogen, occult blood, bilirubin, ketone body, glucose, protein, pH, nitrite, specific gracity, leukocytes, sodium, potassium, chloride - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Variance in data for urinary quantitative data, hematology, serum biochemistry, body weights, food consumption, and absolute and relative organ weights was checked for homogeneity by Bartlett’s test. If the variance was homogeneous, the data were further analyzed by one-way analysis of variance. If not, the Kruskal–Wallis test was applied. When statistically significant differences were observed, the Dunnett’s multiple test was employed to compare between control and treatment groups. The urinary qualitative data and histopathological changes were analyzed with the Kruskal–Wallis test followed by Mann–Whitney’s U-test. Probability values of p < 0.05 were considered significant.
- 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
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Dose descriptor:
- NOEL
- Effect level:
- 3 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Critical effects observed:
- not specified
- Conclusions:
- The NOEL for the test item is 3000 mg/kg bw.
- Executive summary:
In a subchronic toxicity study similar to OECD TG 408 L-serine was administered to 10 Sprague-Dawley rats/sex/dose by oral gavage at dose levels of 0 (control), 500, 1500 and 3000 mg/kg bw. Even the highest dose of 3000 mg/kg bw produced no adverse effects and is therefore regarded as the NOEL.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 3 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a subacute toxicity study according to OECD TG 407 L-serine was administered to 10 Sprague-Dawley rats/sex in a dose of approximately 1000 mg/kg bw. This dose and the resulting chemical intake of 799.9 and 903.0 mg/kg bw for male and female respectively resulted in no adverse effects and is regarded as the NOEL.
In a subchronic toxicity study similar to OECD TG 408 L-serine was administered to 10 Sprague-Dawley rats/sex/dose in diet at dose levels of 0 (control) 0.06, 0.5, 1.5 and 5%. Even the highest dose used (5%) resulting in an average intake of 2765 and 2905.1 mg/kg bw for male and female, respectively produced no adverse effects and is therefore regarded as the NOAEL.
In a further subchronic toxicity study similar to OECD TG 408 L-serine was administered to 10 Sprague-Dawley rats/sex/dose by oral gavage at dose levels of 0 (control), 500, 1500 and 3000 mg/kg bw. Even the highest dose of 3000 mg/kg bw produced no adverse effects and is therefore regarded as the NOEL.
All repeated dose toxicity studies consistently demonstrate the very low toxicity of L-serine. In the reported studies the test animals tolerate L-serine administrated in very high doses (well above the proposed limit dose according to OECD TG 408) and showed no signs of toxicity.
There are no studies available regarding repeated dose toxicity via the dermal route and via the inhalative route. However, although oral intake is not the most appropriate route of exposure it represents a worst case scenario in terms of bioavailability. No evidence for local effects is given. Therefore and due to animal welfare there is no need for further inhalative or dermal repeated dose testing.
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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