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Diss Factsheets
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EC number: 449-400-0 | CAS number: 25822-43-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-08-20 to 2002-09-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (1996)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- (1996)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 449-400-0
- EC Name:
- -
- Cas Number:
- 25822-43-9
- Molecular formula:
- C24H34
- IUPAC Name:
- 1,1'-(2,3-dimethylbutane-2,3-diyl)bis[4-(propan-2-yl)benzene]
- Test material form:
- other: solid, fine scales
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Age at study initiation: About 8 weeks
- Weight at study initiation: 6 Female about 116 g, 6 male about 132 g
- Housing: Single caging in Makrolon cages type III (39 cm x 23 cm x 18 cm). Wire mesh lids. Sanitation of the cages once a week.
- Diet: Altromin 1324 forte, gamma irradiated with 25 kGy 60Co, ad libitum (Producer: Altromin GmbH, D-32791 Lage). Exception: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.
- Water: Tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C
- Humidity: 67.7 %
- Air changes: 12 per hour
- Photoperiod: Artificial light from 6 a.m. to 6 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.1 % Na-carboxymethylcellulose plus 0.1 % Tween 80
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/ kg bw
DOSAGE PREPARATION: The test substance was ground in a mortar and suspended in 0.1 % CMC (carboxymethyl cellulose) plus 0.1 % Tween 80 in deionised water. The suspensions were prepared freshly before administration and were administered within 5 minutes after the preparation.
CLASS METHOD:
- Rationale for the selection of the starting dose: As no prior information on the toxicity of the test substance was available, a starting dose of 200 mg of the test item per kg body weight was chosen. The further proceeding was in accordance with the guideline/directive. - Doses:
- male: 200 and 2000 mg/kg bw
female: 200 and 2000 mg/kg bw - No. of animals per sex per dose:
- 3/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
daily observation for clinical signs 0 - 0.5, 0.5 - 1, 1 -2, 2 - 4 and 4 - 6 hours after administration and at least once a day for a total of 2 weeks. Body weight measurements were done before administration and at day 7 and 14. Body weight gain was calculated for each week of the study.
- Necropsy of survivors performed: Yes. The animals were killed by 80 % CO2 + 20 % air 14 days post application and subjected to a necropsy including a gross pathological examination.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, feed consumption, haematology, clinical biochemistry.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality observed in either male or female rats in any dose.
- Clinical signs:
- other: No relevant signs of toxicity, only signs of discomfort, were observed up to 6 h post application in the high dosed group.
- Gross pathology:
- No relevant toxic effects on organs were observed
- Other findings:
- Slight reduction of plasma urea concentration in the high dosed females was observed.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No mortality and no toxic effects of the test item were observed during the study period. The test item is therefore not classified as "acute toxic" according to the Directive 67/548/EEC (DSD) and the Regulation (EC) No 1272/2008 (CLP).
- Executive summary:
The aim of the study was to investigate acute toxic effects of the test item after a single peroral administration to Sprague-Dawley rats according to the OECD 423. Administration of 200 and 2000 mg/kg bw were performed once per gavage to 3 males and 3 females, respectively. No clinical signs of toxicity and no mortality were observed within the observation period of 14 days. The LD50 was estimated to be > 2000 mg/kg bw.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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