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EC number: 277-288-1 | CAS number: 73138-39-3
- 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
Oral (OECD 423): LD50 rat > 2000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 Aug 2004 - 16 Sep 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 1996
- Deviations:
- yes
- Remarks:
- , lack of details (test substance, animals, housing)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 2002
- Deviations:
- yes
- Remarks:
- , the study was conducted in 2004 following the guideline adopted in 1996, although the guideline had been updated in 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 1996
Directive N° 96/54/EC - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Groupe Interministeriel des produits chimiques, Paris, Republique Francaise
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: not stated
- Purity test date: not stated
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not stated
- Stability under test conditions: not stated
- Solubility and stability of the test substance in the solvent/vehicle: not stated - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle, France)
- Females (if applicable) nulliparous and non-pregnant: not stated
- Age at study initiation: not stated
- Weight at study initiation: 181g to 196g (males) and 168g to 185g (females)
- Fasting period before study: not stated
- Housing:not stated
- Diet: A04 Rat and mouse maintenance diets
- Water: not stated
- Acclimation period: 5-6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 55-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated
IN-LIFE DATES: From: 24 August 2004 To: 08 September 2004 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE: none
MAXIMUM DOSE VOLUME APPLIED: 2.19 mL/kg body weight
ROUTE OF ADMINISTRATION: oral gavage (using a suitable syringe graduated fitted with an oesophageal metal canula) - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- yes
- Remarks:
- Distilled water at 2 mL/kg bw
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily from day 1 to day 14
- Frequency of weighing: day 0, day 2, day 7, day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs at 1, 3, and 5 hours after oral administration on day 0 - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: No clinical signs related to the administration of the test product were observed.
- Gross pathology:
- The macroscopical examinations of the animals at the end of the study did not reveal treatment-related changes.
- Other findings:
- No abnormalities regarding spontaneous activity, Preyer’s reflex (noise), respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lacrimation, righting reflex, back hair appearance assessed at 1, 3, and 5 hours after oral administration.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprised an adequate and reliable study (Klimisch score 2), sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No. 1907/2006.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Justification for type of information:
- No study was conducted as the exposure of humans via inhalation was judged unlikely taking into account the very low vapour pressure of the liquid substance Fatty acids, coco, esters with 1,3-butanediol (CAS 73138-39-3). The vapour pressure of the liquid substance Fatty acids, coco, esters with 1,3-butanediol (CAS 73138-39-3) was calculated to be below <1 x 10-5 kPa (7.5 x 10-5 mmHg) at 20 °C; thus being of low volatility.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- The target substance Fatty acids, C12-18, esters with 1,3-butanediol (CAS 73138-39-3) did not cause mortality or adverse clinical signs in an acute toxicity study following oral administration of 2000 mg/kg bw in male and female rats. Furthermore, no systemic effects were noted in the in vivo skin irritation study performed with Fatty acids, C12-18, esters with 1,3-butanediol (CAS 73138-39-3). Hence, testing for acute dermal toxicity should be avoided for reasons of animal welfare especially as no additional knowledge is expected to be gained by an acute dermal toxicity study considering the outcome of the available, relevant studies.
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity
The acute oral toxicity of Fatty acids, coco, esters with 1,3-butanediol (CAS 73138-39-3) was assessed in a study according to OECD guideline 423 (key study, 2004). Administration of 2000 mg/kg bw to 3 male and 3 female Sprague-Dawley rats via the oral gavage route did not cause mortality and no clinical signs were recorded during the 14-day observation period. No adverse effects were observed.
Overall conclusion for acute toxicity
The available data indicate a very low level of acute toxicity following the oral route and thus Fatty acids, coco, esters with 1,3 -butanediol (CAS 73138 -39 -3) is not considered to be hazardous following acute oral exposure.
Justification for classification or non-classification
The available data on acute toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
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