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EC number: 611-025-7 | CAS number: 53651-69-7
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-06-16 to 2000-02-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted 24th February 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- propyl (2S)-2-hydroxypropanoate
- EC Number:
- 611-025-7
- Cas Number:
- 53651-69-7
- Molecular formula:
- C6H12O3
- IUPAC Name:
- propyl (2S)-2-hydroxypropanoate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): n-propyl lactate
- Analytical purity: 99.5%
- Lot/batch No.: 3
- Appearance: clear, colourless liquid
- Storage conditions: ambient
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
Test material was used undiluted.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: 6-7 weeks
- Housing: 5 animals/cage (stainless steel cages, fitted with wire-screen floor and front); during treatment animals were housed individually
- Diet: standard laboratory diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 65 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 52.5 - 92.5
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: at least 20 cm²
- % coverage: at least 10% of the total body surface
- Type of wrap if used: plastic foil
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- 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 observations: observations were made within 1 hour and within 4 hours after the start of dosing, and subsequently at least once daily throughout an observation period of 14 days
- Frequency of weighing: on day 0, day 3, 7 and 14
- Necropsy of survivors performed: yes, at the end of the observation period (day 14) all animals were killed with carbon dioxide and examined for external changes. Next, the abdomen and thorax of each animal was opened and examined for gross pathological changes.
- Skin reactions were scored according to Draize et al., 1944 (see Table 1 in box "Any other information on materials and methods incl. tables") and were made on day 1, 3, 7 and 14 after patch removal
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the 14-day observation period.
- Clinical signs:
- other: Encrustation of the nose, on day 1 or at 72 h or day 3 recorded in some of the animals. In the skin site treated with the test substance, only slight encrustation was observed in 2 males and 1 female on day 1 of the study. No other clinical symptoms obser
- Body weight:
- other body weight observations
- Remarks:
- no adverse effects on bodyweight gain were noted
- Gross pathology:
- No treatment-associated changes were detected in the animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Propyl (S)-lactate is not dermally toxic and the LD50 is >2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study conducted according to OECD TG 402 groups of young adult Wistar rats (5/sex) were dermally exposed to n-propyl-lactate (purity 99.5%) for 24 hours to at least 10% of the total body surface area at a dose of 2000 mg/kg bw. Animals were observed for 14 days. No mortality was observed among the animals. The only clinical symptom detected was encrustation of the nose on days 1 or 3 of the study. All animals gained weight day during the 14-day observation period, except for a slight dip in the body weight of all males and 4 females, recorded on day 3. No treatment-associated changes were detected in the animals during the gross pathology examination.
Based on the results, the dermal LD50 of the substance for both male and female rats can be considered to be greater than 2000 mg/kg bw.
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