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EC number: 262-334-5 | CAS number: 60623-04-3
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 10, 2016 - March 30, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- performed in compliance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Adopted: 17th December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3-propanediyl bis(2-hexyldecanoate)
- EC Number:
- 262-334-5
- EC Name:
- 2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3-propanediyl bis(2-hexyldecanoate)
- Cas Number:
- 60623-04-3
- Molecular formula:
- C69H132O8
- IUPAC Name:
- 3-[(2-hexyldecanoyl)oxy]-2,2-bis({[(2-hexyldecanoyl)oxy]methyl})propyl 2-hexyldecanoate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Isocarb Ester 1605
- Substance type: Product
- Physical state: liquid
- Lot/batch No.: 03792 or 04549/MA
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 04549/MA
- Expiration date of the lot/batch: 15.05.2018
- Purity test date: not given
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Velaz Prague, Czech Republic
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 180 - 190 g
- Fasting period before study: yes, overnight
- Housing: in plastic cages suspended on stainless steel racks, up to 3 animals per cage
- Diet: laboratory food Altromin (Altromin Spezialfutter GmbH, Germany), offered in recommended doses each day approximately at the same time
- Water: tap water for human consumption ad libitum, quality of drinking water is periodical analysed (including microbiological control) and recorded
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): not mentioned, room equipped with central air conditioning
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: March 15, 2016 To: March, 30, 2016
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: Oil is a standard vehicle according to OECD TG 423
- Lot/batch no. (if required): OC14019842, Galvex
- Purity: not stated
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: available information on similar tested compound indicated that the test item is likely to be nontoxic considering to acute toxicity, therefore a limit dose of 2000 mg/kg was used as a starting dose - Doses:
- 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually immediately after the administration of the test item and then 0.5, 1, 2, and 4 hours later. Then each animal was inspected daily for the next 14 days. Individual weights of animals were determined shortly before the test item was administered and weekly thereafter.
- Necropsy of survivors performed: All test animals were subjected to gross necropsy.
- Other examinations performed: clinical signs (observations included changes in skin and fur, eyes and mucous membranes, respiratory,circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern, observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma), body weights (weight differences after first and second weeks after administration were calculated and recorded), gross pathological changes (full, detailed gross necropsy included careful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents) - Statistics:
- not performed
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 was observed during the study.
- Clinical signs:
- other: Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered.
- Gross pathology:
- During necropsy, no macroscopically changes were noticed.
- Other findings:
- none
Any other information on results incl. tables
Table: Body Weight | ||||||||
Sex | Dose | ID | Body weight (g) | Body weight difference (g) | ||||
initial | week 1 | week 2 | week 1 - initial | week 2 - initial | week 2 - week 1 | |||
♀ | 2000 mg/kg | 1 | 190 | 220 | 230 | 30 | 40 | 10 |
2 | 180 | 210 | 220 | 30 | 40 | 10 | ||
3 | 190 | 210 | 210 | 20 | 20 | 0 | ||
4 | 190 | 220 | 230 | 30 | 40 | 10 | ||
5 | 180 | 200 | 220 | 20 | 40 | 20 | ||
6 | 190 | 220 | 230 | 30 | 40 | 10 | ||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item 2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3-propanediyl bis(2-hexyldecanoate) is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
- Executive summary:
The purpose of the study was to evaluate the potential toxic effect of the test item 2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3-propanediyl bis(2-hexyldecanoate) when administered as a single oral dose to Wistar rats.
The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used. Available information indicated that the test item is likely to be non-toxic; therefore, a limit dose of 2000 mg/kg was used as a starting dose. Two groups of 3 females were dosed. All 6 females survived the limit dose. The limit dose of 2000 mg/kg did not cause death, evident signs of toxicity or body weight loss during the 14-day long observation period. Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg of OECD Guideline 423 it can be concluded that the LD50 of the test item 2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3 - propanediyl bis(2-hexyldecanoate) is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
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