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EC number: 938-347-3 | CAS number: 28068-91-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted by GLP accredited laboratory. Method according to OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of (2R,4R)-4-(2,3-dimethylbutan-2-yl)-2-methylcyclohexanone and (2S,4S)-4-(2,3-dimethylbutan-2-yl)-2-methylcyclohexanone
- EC Number:
- 938-347-3
- Cas Number:
- 28068-91-9
- Molecular formula:
- C13H24O
- IUPAC Name:
- Reaction mass of (2R,4R)-4-(2,3-dimethylbutan-2-yl)-2-methylcyclohexanone and (2S,4S)-4-(2,3-dimethylbutan-2-yl)-2-methylcyclohexanone
- Details on test material:
- - Name of test material (as cited in study report): Iriswood
- Substance type: pure active substance
- Physical state: undercooled liquid
1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Six female Sprague-Dawley rats (SPF Caw) from Elevage JANVIER, France of 8 weeks old were selected having body weights from 181-199g.
A controlled environment was maintained in the room with optimal conditions of approximately 15/h air changes, a temperature of 19-25ºC, a relative humidity of 30-70% and a 12 hour light/12 hour dark cycle per day (light cycle 7.00-19.00h).
3 animals were present in a solid-bottomed polycarbonate cage with a stainless steel mesh lid containing sawdust bedding that was exchanged twice a day. Animals were acclimitised for a period of 5 days prior to exposure. The animals had free access to tap water and food (M20, SDS).
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test item was administered by gavage under a volume of 2.19 mL/kg body weight (corresponding to 2 g/kg, according to the calculated density) using a suitable syringe graduated fitted with an oesophageal metal canula.
- Doses:
- The dose level was 2000 mg/kg (2.19 ml/kg body weight) on day 0.
- No. of animals per sex per dose:
- 3 female rates per group. Two groups of rats.
- Control animals:
- yes
- Details on study design:
- The animals were daily systematically examined on behavioural or toxic effects on the major physiological functions at 0.5, 1, 3, 4 and 24 hours after the administration of the test item and daily during 14 days following the administration of the test item. Symptoms were recorded as "present" or "absent" on the observation sheet. These observations were compared to historical control data. The animals were observed for the presence of spontaneous activity, preyer’s reflex (noise), respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex and back hair appearance.
Animals were weighed on days 0 (just before administration), 2, 7 and 14.
On day 14, the animals were anaesthetised with sodium pentobarbital. Macroscopic observations were entered on individual autopsy sheets. Only those organs that were likely to be modified in case of acute toxicity were examined. - Statistics:
- The method used is not intended to calculate a precise LD50, hence no statistical analysis was performed. The oral LD50 was ranked and an LD50 cut-off value determined based on the OECD 423 guideline.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: cut-off value
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: No clinical signs related to the administration of the test item were observed during the study.
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not reveal treatment related changes.
Any other information on results incl. tables
Table 1 Body weight and weight gain in grams of the six female rats subjected to the test substance at a dose of 2,000mg/kg bw.
D0 | D2 | D2-D0 | D7 | D7-D0 | D14 | D14-D0 | |
Females | |||||||
Rf 0181 | 187 | 204 | 17 | 217 | 30 | 229 | 42 |
Rf 0182 | 186 | 193 | 7 | 210 | 24 | 227 | 41 |
Rf 0183 | 181 | 191 | 10 | 206 | 25 | 221 | 40 |
Rf 0192 | 198 | 206 | 8 | 226 | 28 | 242 | 44 |
Rf 0193 | 194 | 205 | 11 | 213 | 19 | 240 | 46 |
Rf 0194 | 191 | 202 | 3 | 222 | 23 | 234 | 35 |
Mean | 190.8 | 202.2 | 9.3 | 215.7 | 24.8 | 232.2 | 41.3 |
Std Dev | 7.3 | 6.5 | 4.7 | 7.5 | 3.9 | 8.0 | 3.8 |
Dx (x=0,2,7,14) stands for the number of days after the administration of the test substance.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The oral LD50 of the test substance in Wistar rats exceeds 2,000 mg/kg body weight. the LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg body weight by oral route in the rat.
- Executive summary:
The acute toxicity class method (OECD 423 (2001)) was used to assess the acute toxicity of test substance in 6 female Sprague-Dawley rats.
The test substance was administered by oral gavage to the rats at a dose level of 2,000 mg/kg body weight. Animals were observed daily and their body weights were weekly recorded. Macroscopic examination was performed after sacrifice.
No mortality occurred and no clinical signs related to the administration of the test item were observed. The body weight gain was normal.
No abnormalities were found at post mortem macroscopical examinations of the animals.
The LD50 of the test substance exceeds 2,000 mg/kg body weight. Based on the result, the LD50 cut-off value may be considered >5,000 mg/kg body weight.
Consequently, the test substance does not need to be classified for acute oral toxicity according to Regulation EC No. 1272/2008 and GHS.
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