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EC number: 700-071-4 | CAS number: 932742-30-8
- 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:
- 2008-11-11 until 2008-11-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is regarded as reliable without restrictions because it was conducted in compliance with GLP regulation and guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-({[(1S,5R)-5-{[3-(dodecanoyloxy)-2,2-dimethylpropylidene]amino}-1,3,3-trimethylcyclohexyl]methyl}imino)-2,2-dimethylpropyl dodecanoate; 3-({[(1S,5S)-5-{[3-(dodecanoyloxy)-2,2-dimethylpropylidene]amino}-1,3,3-trimethylcyclohexyl]methyl}imino)-2,2-dimethylpropyl dodecanoate
- EC Number:
- 700-071-4
- Cas Number:
- 932742-30-8
- Molecular formula:
- C44H82N2O4
- IUPAC Name:
- 3-({[(1S,5R)-5-{[3-(dodecanoyloxy)-2,2-dimethylpropylidene]amino}-1,3,3-trimethylcyclohexyl]methyl}imino)-2,2-dimethylpropyl dodecanoate; 3-({[(1S,5S)-5-{[3-(dodecanoyloxy)-2,2-dimethylpropylidene]amino}-1,3,3-trimethylcyclohexyl]methyl}imino)-2,2-dimethylpropyl dodecanoate
- Reference substance name:
- 3-((5-(3-(Dodecanoyloxy)-2,2-dimethylpropylideneamino)-1,3,3-trimethylcyclohexyl)methylimino)-2,2-dimethylpropyldodecanoate
- IUPAC Name:
- 3-((5-(3-(Dodecanoyloxy)-2,2-dimethylpropylideneamino)-1,3,3-trimethylcyclohexyl)methylimino)-2,2-dimethylpropyldodecanoate
- Test material form:
- other: liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (Europe) Laboratories Inc.
TOXI COOP Ltd. 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: Young adult rats, 7 weeks old
- Weight at study initiation: 160 – 175 g
- Housing: Group caging (3 animals/cage)
- Diet (e.g. ad libitum): ssniff SM R/M-Z+H, ad libitum
- Water (e.g. ad libitum): tap water from municipal supply, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2-25.0 °C
- Humidity (%): 34 - 68 %
- Air changes (per hr): 8-12 air exchanges/hour by central air-condition system.
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- A single oral administration - followed by a fourteen days observation period - was performed by gavage. Animals were treated with the test item prepared freshly in the morning hours. A constant treatment volume of 10 mL/kg bodyweight was applied. The concentration was adjusted to ensure constant treating
volumes. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 female animals (nulliparous, non pregnant)
3 animals/step - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually continuously during the first 30 minutes, 1 h, 2 h, 3 h, 4 h, 6 h after the treatment and once each day for 14 days thereafter. The body weights were measured and recorded on day -1 and 0 (beginning of the experiment), and on days 7 and 14 with a precision of 1 g.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: gross pathology - Statistics:
- NA
Results and discussion
- Preliminary study:
- No preliminary study.
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- SIKA Hardener LI did not cause mortality at 2000 mg/kg bw.
- Clinical signs:
- other: Treatment group 1 – 2000 mg/kg bw Treating with SIKA Hardener LI at a dose level of 2000 mg/kg bw did not cause any adverse treatment related effects in this dose group. Treatment group 2 – 2000 mg/kg bw Treating with SIKA Hardener LI at a dose level of
- Gross pathology:
- 2000 mg/kg bw – Treatment group 1
Mottled pale areas in the liver, diffuse dark red discolouration of the lung and collapsed lung with dark red focus was observed in this dose group.
2000 mg/kg bw – Treatment group 2
Uterus in oestrus was recorded in case of one animal in this dose group.
In summary, a single oral gavage treatment with SIKA Hardener LI did not cause any test article related adverse effects, all findings were typical of rats following euthanasia and exsanguination. - Other findings:
- No other findings
Any other information on results incl. tables
- The method used is not intended to allow calculation of a precise LD50 value, but an LD50 value is assigned, according to the OECD Guideline No.423 and Comission Regulation (EC) No 440/2008, Annex Part B, B.1.tris: "Acute Oral Toxicity – Acute Toxic Class Method", Official Journal of the European Union No. L 142, dated May 31st, 2008.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the present study, a single oral administration of the test item SIKA Hardener LI at the dose level of 2000 mg/kg bw did not cause any treatment related adverse effects.
- Executive summary:
The acute toxicity oral of SIKA Hardener LI was examined by an acute toxic class method according to the OECD Guideline 423 and the EU method B.1. Two groups of three female Wistar rats were treated with SIKA Hardener LI by a single oral administration by gavage at a dose levels of 2000 mg/kg bw using Polyethylene glycol as a vehicle. The concentration of the formulations in Polyethylene Glycol was 200 mg/mL administered by a constant treatment volume of 10 mL/kg bw. Based on the results of the study and according to the criteria of the relevant test guidelines no further testing was performed.
No mortalities were recorded. No clinical signs were observed under the duration of the 14 days observation period.
The body weight gain of the animals was considered to be normal with no indication of test item related effect.
The macroscopic examination revealed some minor alterations as mottled pale areas in the liver, diffuse dark red discolouration of the lung, dark focus on the lung and collapsed lung. Additionally uterus in oestrus was recorded in one animal.
All of the changes listed below were considered to be agonal or incidental.
Under the conditions of the present study, a single oral administration of the test item SIKA Hardener LI at the dose level of 2000 mg/kg bw did not cause any treatment related adverse effects. Thus, the LD0 value and LD50 values assigned were 2000 mg/kg bw and > 2000 mg/kg bw, respectively.
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