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EC number: 252-478-7 | CAS number: 35274-05-6
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Sufficient data on materials and methods, but study probably not performed under GLP.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Analogues are C12 and C13 alkyl lactates.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Esterification of fatty alcohols with lactic acid.
3. ANALOGUE APPROACH JUSTIFICATION
C12 lactate is a constituent of Propanoic acid, 2-hydroxy, C12-C16 (even numbered) alkyl esters.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Propanoic acid, 2-hydroxy-, C12-15-alkyl esters
- EC Number:
- 300-338-1
- EC Name:
- Propanoic acid, 2-hydroxy-, C12-15-alkyl esters
- Cas Number:
- 93925-36-1
- Molecular formula:
- C3O2-C12/13/14/15
- IUPAC Name:
- Propanoic acid, 2-hydroxy-, C12-15-alkyl esters
- Details on test material:
- The test material consisted of a colourless liquid contained in a plastic bottle
The test material was received on October 19, 1993 and identificated with entry no. 3427/1.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- The animals were caged in groups of 5 of the same gender in transparent polycarbonate cages (dimensions mm 425X266X180h).
- The housing room was mantained under the following conditions:
x Temperature: 20 ± 2 dC
x Humidity: 55% ± 15% R.H.: Air was changed at least 25 times per hour and maintained at a pressure higher than the outside atmosphere.
x Artificial lighting: 12 h/day.
x The cages and the housing room were cleaned and disinfected before the animals wereaccomodated, then cleaning and disinfection were performed periodically
- Source: "Nossan" - Correzzana MI - ITALY
- Weight at study initiation: 180-200 g
- Fasting period before study: not specified
- Housing: not specified
- Diet: Animals were fed with standard pellet complete diet supplied by the authorized breeder NOSSAN.
- Water: Filtered tap water from local network was supplied ad libitum.
- Quarantine/Acclimation period: Before being used in this study, the animals were kept in quarantine for one week. During this period they were observed daily. At the end of the quarantine week the animals were carefully examined in order to evaluate their suitability for the study.
- Animal selection: The animals used for this study were selected randomly from those suitable, available at that time.
Administration / exposure
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Approximately 24 hours before the test fur was removed by clipping and shaving a dorsal area about 25 cm2 wide.
- The sample was put on a patch (Hansamed strips) the dorsal area of animals. The patch was then covered by an impermeable and hypoallergenic plastic adhesive tape (Blenderm 3M).
- No control group was used.
REMOVAL OF TEST SUBSTANCE
The patch was removed 24 hours after application. The exceeding material was then washed away from skin using a pad soaked in distilled water. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- OBSERVATIONS
- General conditions of the animals were controlled daily for 14 days (5 days a week) .
- All data relative to the study, including observations and examination were recorded and signed daily.
- Mortality: Animals were observed in the morning of every working day.
- Clinical signs and behavior: Every clicnical symptom, including possible variations in somotomotor activity, was daily recorded in every single animal. Observations included: tegumentary apparatus, mucosae conditions, respiratory activity and sensorium conditions.
- Body weight: Animals were weighed before the experiment, after 7 days and then at the end of the study.
- Necropsy: At the end of the observation period rats were sacrificed and a necroptic survey was performed. - Statistics:
- INTERPRETATION OF RESULTS
Results have been interpreted according to EEC Directives 93/21.
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 death occurred during the study.
- Clinical signs:
- No clinical signs were observed during the experimental observation period.
- Body weight:
- The body weight gain was considered normal for the species and strain of rats used in this study.
- Gross pathology:
- At the ante-mortem and post-mortem examination in all animals no pathological symptoms were observed. No macroscopic abnormalities were seen at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results interpreted according to EEC Directives 93/21indicate that the test material, COSMACOL EL, can be considered NON TOXIC and NON HARMFUL.
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