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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-07-09 to 2002-08-06
- 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:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- statement
- Test type:
- standard acute method
- Limit test:
- yes
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 Wiga GmbH, D-97633 Sulzfeld
- Age at study initiation: About 8 weeks (males) and 12 weeks (females)
- Weight at study initiation: females (mean) = 243 g; males (mean) = 271 g
- Housing: Single caging in Makrolon cages type III (39 cm x 23 cm x 15 cm). Wire mesh lids. Sanitation of the cages once a week.
- Diet: Altromin 1324 forte, gamma irradiated with 25 kGy 60Co, ad libitum (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: average 23 °C
- Humidity: average 69 %
- Air changes: 12 per hour
- Photoperiod: Artificial light from 6 a.m. to 6 p.m.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal thoracal region. The hair of the dorsal trunk was clipped with an electrical hair clipper (Aesculap GH, 0.1 mm cutterhead) one day before the application of the test substance. The individual amounts of the test substance were calculated using the body weights determined on the day of the administration.
- % coverage: 10 % of estimated body surface (6.5 x 8 cm = 52 cm2)
- Type of wrap if used: A cellulose patch (Pur-Zellin, Hartmann AG) with the calculated amount of the test substance overlying soaked with deionised water to get optimal contact with the skin, was applied to the test site and held in place by fixing marginally with non irritating tape (Blenderm Wundpflaster, 3M). Patch and tape were covered semi-occlusively by a dressing (Fixomull Stretch, Fa. Beiersdorf).
REMOVAL OF TEST SUBSTANCE
After 24 hours of exposure the dressing was removed and the test substance was wiped off using wet cellulose tissue.
TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw were applied using a water soaked cellulose patch to guarantee optimal skin contact. - Duration of exposure:
- 24 h
- Doses:
- dose range finding study (400, 894 and 2000 mg/kg bw/ day)
main study (2000 mg/kg bw/ day) - No. of animals per sex per dose:
- 3 males and 3 females for dose range finding study (1 animal /sex/ dose)
5 male and 5 females for main study (2000 mg/kg bw) - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 0, 0.5, 1, 2, 4 and 6 hours after administration of the test substance and once a day for a total of 14 days
- Frequency of observations and weighing: observation of systemic signs of toxicity was performed every day. Body weight was measured at day 0, 7 and 14. Body weight gain was calculated for each week.
- 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.
Results and discussion
- Preliminary study:
- No mortality was observed for any tested dose of the preliminary dose range finding study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Low signs of discomfort (chromodacryorrhoea) was found in 1 female after 1-2 days post application.
- Gross pathology:
- No effects of organ toxicity were observed during necroscopy.
- Other findings:
- Local irritations were found in 1 female 1 to 7 days post application.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No mortality or toxic effects of the test item were observed at maximal tested dose of 2000 mg/kg bw. The test item is therefore not classified for acute dermal toxicity according to the Directive 93/21/EEC (DSD) and 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 dermal administration to rats according to the OECD 402. Administration of 2000 mg/kg bw were performed once under semi- occlusive conditions to 5 males and 5 females, respectively. No mortality and no signs of clinical toxicity 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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