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EC number: 253-981-4 | CAS number: 38517-37-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
From January 15 2013 to 30 January 2013- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: See remarks
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficienses, which do not affect the quality of the relevant results. The sudy report was conclusive, done to a valid guideline and the study was conducted under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Potassium (2S)-4-carboxy-2-(tetradecanoylamino)butanoate
- Cas Number:
- 72716-26-8
- Molecular formula:
- C19H34NO5K
- IUPAC Name:
- Potassium (2S)-4-carboxy-2-(tetradecanoylamino)butanoate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch 110825
white powder
Shelf life 3 years from production date
Storage conditions room temperature (15 °C - 25 °C)
Routine safety protections
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- CRL:(WI)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test animals:
- Weight at study initiation: 202 - 211 g
- Age at study initiation: young healthy adult rats, 9-10 weekd old
- Fasting period before study: overnight
- Housing: in groups of 3 per cage, standard housing conditions, Type II polypropylene/polycarbonate cages used
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 12 days
- Females are nulliparous and non pregnanat
Environmental conditions
- Temperature (°C): 19.2 - 21.9
- Humidity (%): 34 - 66
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 hours daily from 6.00 a.m. to 6.00 p.m
IN-LIFE dates: from 15 January 2013 to 30 January 2013
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Distilled water
- Details on oral exposure:
- Maximum volume applied: 10 ml/kg bw
The test material was freshly formulated at the concentation of 200 mg/ml in the vehicle. on the day of administration. The formulation container was stirred continuosly up to finishing the treatment.
CLASS METHOD
- Rationale for the selection of the starting dose: The initial dose level was selected by the study director to be that which is most likely to produce mortality in some of the dosed animals. In the lack of any preliminary toxicological information, 2000 mg/kg bw was selected to be the starting dose. - Doses:
- Single dose of 2000 mg/kg bw
- No. of animals per sex per dose:
- Two groups of three females were dosed.
- Control animals:
- no
- Details on study design:
- Dosing procedure: Initially, three females (Group 1) were dosed, and then based on the observations a further group of three females (Group 2) were dosed.
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
> Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
> Body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0) and weekly thereafter.
- Necropsy of survivors performed: Yes, macroscopic examination was performed on all animals. The animals were sacrificed by exsanguination under pentobarbital anaesthesia. After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed. Macroscopic abnormalities were recorded.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured
- Clinical signs:
- other: Treatment at the dose level of 2000 mg/kg bw caused vocalisation (3/6), hunched back (6/6), irritability (3/6). Group 1 was symptom free from 6 hours after the treatment and Group 2 was symptom free from one day after the treatment. See Table 1 for result
- Gross pathology:
There was no evidence of any gross findings at a dose level of 2000 mg/kg bw.
Any other information on results incl. tables
Table 1: Clinical Observations
Group No. | Animal No. | Observation | Observation Time | Frequency | ||||||||||||
30 min | 1 h | 2 h | 3 h | 4 h | 6 h | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7-14 | ||||
1 | 8897 | Symptom Free | - | - | - | - | - | + | + | + | + | + | + | + | + | 15/20 |
Vocalisation | + | + | + | - | - | - | - | - | - | - | - | - | - | 3/20 | ||
Irritability | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | 2/20 | ||
Hunched Back | + | + | + | + | + | - | - | - | - | - | - | - | - | 5/20 | ||
8898 | Symptom Free | - | - | - | - | - | + | + | + | + | + | + | + | + | 15/20 | |
Vocalisation | + | + | - | - | - | - | - | - | - | - | - | - | - | 2/20 | ||
Irritability | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | 2/20 | ||
Hunched Back | + | + | + | + | + | - | - | - | - | - | - | - | - | 5/20 | ||
8899 | Symptom Free | - | - | - | - | - | + | + | + | + | + | + | + | + | 15/20 | |
Vocalisation | + | + | - | - | - | - | - | - | - | - | - | - | - | 2/20 | ||
Irritability | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | 2/20 | ||
Hunched Back | + | + | + | + | + | - | - | - | - | - | - | - | - | 5/20 | ||
2 | 8900 | Symptom Free | - | - | - | - | - | - | + | + | + | + | + | + | + | 14/20 |
Hunched Back | + | + | + | + | + | + | - | - | - | - | - | - | - | 6/20 | ||
8901 | Symptom Free | - | - | - | - | - | - | + | + | + | + | + | + | + | 14/20 | |
Hunched Back | + | + | + | + | + | + | - | - | - | - | - | - | - | 6/20 | ||
8902 | Symptom Free | - | - | - | - | - | - | + | + | + | + | + | + | + | 14/20 | |
Hunched Back | + | + | + | + | + | + | - | - | - | - | - | - | - | 6/20 |
+ = present; - = absent
Frequency of observations = number of occurance of observation/ total number of observations
Severities: 1 = Slight/Small/Few; 2 = Moderate/Medium; 3 = Market/Large/Many
Table 2: Body Weight
Group No. | Animal No. | Body weight (g) Day | Body Weight Gain (g) Days | ||||||
-1 | 0 | 7 | 14 | -1 - 0 | 0 - 7 | 7 - 14 | -1 - 14 | ||
1 | 8897 | 223 | 208 | 235 | 265 | -15 | 27 | 30 | 42 |
8898 | 223 | 210 | 229 | 242 | -13 | 19 | 13 | 19 | |
8899 | 215 | 202 | 226 | 244 | -13 | 24 | 18 | 29 | |
2 | 8900 | 218 | 211 | 237 | 245 | -7 | 26 | 8 | 27 |
8901 | 211 | 202 | 244 | 249 | -9 | 42 | 5 | 38 | |
8902 | 205 | 195 | 228 | 234 | -10 | 33 | 6 | 29 | |
Mean: | 215.8 | 204.7 | 233.2 | 246.5 | -11.2 | 28.5 | 13.3 | 30.7 | |
Standard Deviation: | 7.1 | 6.1 | 6.8 | 10.3 | 3.0 | 8.0 | 9.5 | 8.2 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the acute oral LD50 of the substance in rats was determined to be >2000 mg/kg bw
- Executive summary:
The acute oral toxicity of the test material was determined in a GLP study conducted in line with OECD 423, EU Method B.1 tris and EPA OPPTS 870.110, according to the acute toxic class method. A total of six fasted female Wistar rats were exposed to the test material at 2000 mg/kg bw by oral gavage. Individuals were observed for mortality, clinical signs of toxicity, bodyweight gain and then submitted for necropsy 14 days after exposure. Initially, three female animals were treated with the test material at 2000 mg/kg bw. No mortality was observed, therefore further 3 animals were treated at the dose level of 2000 mg/kg bw. As no mortality was observed in this second dose group, further testing was not required according to the test guideline. Under the conditions of the test no mortality was observed, individual weight gain showed no signs of treatment related effects, and t here was no evidence of any gross findings at necropsy. Clinical signs were observed in some individuals, vocalisation (3/6), hunched back (6/6), irritability (3/6). However, Group 1 was symptom free from 6 hours after the treatment and Group 2 was symptom free from one day after the treatment. Based on these observations the acute oral LD50 of the test material was determined to be > 2000 mg/kg bw in female Wistar rats.
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