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EC number: 252-036-3 | CAS number: 34451-19-9
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1991 to 1995-08-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- adopted May 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- traditional method
- Limit test:
- yes
Test material
- Reference substance name:
- Butyl (S)-2-hydroxypropionate
- EC Number:
- 252-036-3
- EC Name:
- Butyl (S)-2-hydroxypropionate
- Cas Number:
- 34451-19-9
- Molecular formula:
- C7H14O3
- IUPAC Name:
- butyl 2-hydroxypropanoate
Constituent 1
- Specific details on test material used for the study:
- - Name: n-butyl-S(-)-2-hydroxy propionate
- Purity: > 97%
- Appearance: Clear liquid
- CAS: 138-22-7 (although this is the CAS number for butyl lactate of unspecified stereochemistry, the substance is clearly identified as the S-enatiomer)
- Storage: room temperature
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeding Center for Laboratory Animals, Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 7-8 weeks
- Mean weight at study initiation: 212 g for males and 163 g for females
- Housing: 5 males or females/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19–21.5
- Humidity (%): On several days the relative humidity fluctuated between 70 and 80 %. Higher values (up to 88 %) were reached for short periods of time, due to cleaning activities.
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Remark on MMAD/GSD:
- See Table 1 in box "Any other information on results incl. tables".
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber: consisted of a 5-sections cylindrical aluminium column (ca. 60 L) surrounded by a transparent PVC cylinder
- Method of holding animals in test chamber: plastic animal holders (Battelle)
- System of generating particulates/aerosols: The test atmosphere was generated by atomizing the test material into small droplets by using a compressed air driven nebulizer of the Institute's design. The nebulizer consisted of an atomizer and a glass jar, containing the test material. The atomizer coded DR Oil, was purchased from Lechler (Germany). The nebulizer was operated at a pressure of 1.0 bar. During operation, the test material was drawn through a sucking pipe to the atomizer. The generated spray was blown against a baffle which was fitted approximately 8 cm below the nozzle orifice to remove the larger droplets. The impacted test material was drained back into the test material supply at the bottom of the jar. The resulting aerosol was passed from the glass jar to the inlet of the exposure unit. From there it was directed downward through the mixing chambers towards the animal noses. At the bottom of the unit the test atmosphere was exhausted.
- Method of particle size determination: by using an 11-stage cascade impactor
- Total air flow: 1.5 m³/h
- Temperature, humidity, pressure in air chamber: The mean temperature was 20.7 ± 0.1 °C. Relative humidity was less than 1 %.
TEST ATMOSPHERE
- Brief description of analytical method used: The actual concentrations of the test atmosphere were determined once every hour by GC
- Samples taken from breathing zone: No
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: See Table 1 in box "Any other information on results incl. tables". - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- ca. 4 h
- Concentrations:
- 5 g/m³ (target concentration), the analytically verified concentration was 5.14 g/m³
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of clinical observations: before, during and after exposure, and once daily during the observation days
- Weighing: recorded prior to exposure and at days 7 and 14
- Necropsy of survivors performed: yes, at the end of the observation period, surviving rats were killed by exsanguination from the abdominal aorta under ether anaesthesia. All rats were autopsied and examined for gross pathological changes.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.14 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occured.
- Clinical signs:
- other: During exposure, visually decreased breathing frequency and wet nose and head were observed in all animals to the same extent. Immediately after exposure, visually decreased breathing frequency and wet head were still present. A wet fure was observed in a
- Body weight:
- Normal body weight gain was observed in all rats during the observation period (see Table 2 in box "Any other information on results incl. tables").
- Gross pathology:
- No treatment-related lesions were detected after the examination.
Any other information on results incl. tables
Analytical results:
Mean actual concentration (and standard deviation) turned out to be 5.14 (0.13) g/m³. Particle size distribution is given below in Table 1.
Table 1: Aerodynamic particle size distribution of n-butyl-S-(-)-lactate test atmosphere
Aerodynamic diameter (µm) |
Distribution in % total mass |
< 1.0 |
0.0 |
1.0 |
0.3 |
1.4 |
1.1 |
1.8 |
1.5 |
2.4 |
6.5 |
2.8 |
20.0 |
3.1 |
20.7 |
3.4 |
31.2 |
3.8 |
9.0 |
4.2 |
2.4 |
> 4.2 |
7.2 |
Body weight:
Normal body weight gain was observed in all rats during the observation period.
Table 2: Individual and mean body weights of male and female rats exposed to n-butyl-S-(-)-lactate aerosols for 4 h.
|
Body weight (g) |
|||||
Males |
Females |
|||||
Day 0a |
Day 7 |
Day 14 |
Day 0a |
Day 7 |
Day 14 |
|
209 |
235 |
272 |
169 |
176 |
192 |
|
222 |
234 |
265 |
167 |
177 |
191 |
|
213 |
239 |
270 |
167 |
170 |
183 |
|
221 |
238 |
271 |
160 |
163 |
174 |
|
193 |
209 |
239 |
153 |
157 |
169 |
|
Mean |
212 |
231 |
263 |
163 |
168 |
182 |
a: just before exposure
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute inhalation toxicity study in rats, conducted in accordance with OECD test guideline 403, no mortality occurred. Based on the results, the 4 h inhalative LC50 for n-butyl-S-(-) lactate can be considered to be greater than 5.14 mg/L in rats.
- Executive summary:
In an acute inhalation toxicity study, young adult Wistar rats (5/sex), were exposed by nose-only inhalation to aerosols of n-butyl-S-(-)-lactate (> 97% purity) at a concentration of 5.14 mg/L in air, one single time for a period of 4 hours. Animals were observed for 14 days. No mortality occurred. Clinical observations revealed visually decreased breathing frequency, wet head and/or fur, during and shortly after exposure. No abnormalities were observed during the 14-day observation period. All rats showed normal body weight gain during the observation period. No gross lesions were detected at necropsy. Since no mortality occurred during the entire observation period, the LC50 can be considered to be greater than 5.14 mg/L.
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