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EC number: 233-215-5 | CAS number: 10081-67-1
- 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
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- Endpoint summary
- Stability
- Biodegradation
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- 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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 to 28 November 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with OECD test guideline in compliance with GLP and reported with a valid GLP certificate.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(1-methyl-1-phenylethyl)-N-[4-(1-methyl-1-phenylethyl)phenyl]aniline
- EC Number:
- 233-215-5
- EC Name:
- 4-(1-methyl-1-phenylethyl)-N-[4-(1-methyl-1-phenylethyl)phenyl]aniline
- Cas Number:
- 10081-67-1
- Molecular formula:
- C30H31N
- IUPAC Name:
- 4-(2-phenylpropan-2-yl)-N-[4-(2-phenylpropan-2-yl)phenyl]aniline
- Test material form:
- not specified
- Details on test material:
- Identification: DUSANTOX 86, Certificate of analysis No. 040707/A9Batch number: 005/07Storage conditions: The test article was maintained in a dark package, in the room No. 252 (at room temperature) of the Toxicology and Pathology Dept, where was prepared for the administration. Long term storage: protected against sunlight. Stable: for 24 months.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino, not specified
- Details on test animals or test system and environmental conditions:
- Species: Albino rabbitSource: VŰŽV Nitra, SlovakiaNumber and sex: Four healthy young adult animals (males), weighing from 3,63kg to 4,62kgIdentification: The animals were housed individually in cages. The animals were marked by serial numbers 1 – 4. These numbers were placed in the cage and on the auricle. Husbandry:Housing: Animals were housed in cages individually. Diet: A standard certified laboratory diet (supplier Top Dovo Dobrá Voda) was served. The diet is routinely analysed by the manufacturer for nutritional components and environmental contaminants. Water: Ad libitum.Environment: Environmental control for the animal room was set to maintain 18 ± 3°C, a relative humidity of 40 – 70% a minimu of 10 air changes/hour, and a natural light regime. Acclimation: According SOP No 001/53204/07 Quarantine of animals.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Olivae oleum raffinatum
- Controls:
- no
- Amount / concentration applied:
- A dose of 0.5 g of Dusantox 86 was pulverised, moistened with the vehicle. Vehicle Article: Olivae oleum raffinatum, Certificate of analysis No 625/539/64/2007, Lot Number: L706203
- Duration of treatment / exposure:
- exposure period 4 hours.
- Observation period:
- 72 hours.
- Number of animals:
- 4 male rabbits.
- Details on study design:
- Preparation of dosesThe test article was pulverised and moistened sufficiently with olivae oleum shortly prior to administration. Test ProcedurePreparation of Test Area: Approximately 24h before the test, fur was removed from the test area by clipping from the dorsal area of the trunk of the animals. Only animal with healthy intact skin were used. Exposure of Animals: The study was begun with an initial test using one animal. The test article was applied to a small area (approximately 6 cm2) of skin and covered with a gauze patch. The patch was loosely held in contact with the skin by means of a suitable semi-occlusive dressing for the duration of the exposure period (4h). At the end of the exposure period, residual test preparation was removed using olivae oleum. Because a corrosive effect was not observed in initial test, the irritant response was confirmed using up to three additional animals simultaneously.Application of Test Article: The test article (0.5 g) was moistened sufficiently with olivae oleum and was applied to the skin and to the gauze patch.Observation of Animals: The appearance of skin reactions was observed and recorded at 1h, 24h, 48h and 72 h following removal of the patches. The skin reactions for erythema and oedema were described and graded according to the classification system for the application site at each time interval.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Irritation score: 0.33
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Irritation score: 0.5
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Irritation score: 0.17
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0 - <= 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Irritation score: 0.67
- Irritant / corrosive response data:
- Because a corrosive effect was not observed in initial test, the irritant response was confirmed using up to three additional animals simultaneously.
- Other effects:
- The well-defined erythema classified as grad 2 was observed as the worst skin reaction on the Dusantox 86 only in one animal. Skin reactions on other animals were determined as grad 1 – very slight erythema. No observation of erythema or oedema was noted on the vehicle application site. During 7 days after removal of patches erythema had disappeared in all animals. No oedema was occurred in the course of study.
Any other information on results incl. tables
Table 3. Score of reaction – numerical grading for skin reaction
Animal No. | Weight (kg) | Date of application | Time observation after removal patches | Irritation scores Dusantox 86 | Irritation Scores of each animalΣErythema + oedema : 6 | Primary irritation index (PII) | ||
h. | date | Erythema | Oedema | |||||
1 | 4.33 | 13.11.07 | 1 | 13.11.07 | 1 | 0 | 0.33 | 0.4 |
24 | 14.11.07 | 1 | 0 | |||||
48 | 15.11.07 | 1 | 0 | |||||
72 | 16.11.07 | 0 | 0 | |||||
2 | 3.65 | 14.11.07 | 1 | 14.11.07 | 1 | 0 | 0.5 | |
24 | 15.11.07 | 1 | 0 | |||||
48 | 16.11.07 | 1 | 0 | |||||
72 | 17.11.07 | 1 | 0 | |||||
3 | 3.63 | 14.11.07 | 1 | 14.11.07 | 1 | 0 | 0.17 | |
24 | 15.11.07 | 1 | 0 | |||||
48 | 16.11.07 | 0 | 0 | |||||
72 | 17.11.07 | 0 | 0 | |||||
4 | 4.62 | 14.11.07 | 1 | 14.11.07 | 1-2 | 0 | 0.67 | |
24 | 15.11.07 | 2 | 0 | |||||
48 | 16.11.07 | 1 | 0 | |||||
72 | 17.11.07 | 1 | 0 | |||||
Response category | Negligible |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The Primary Irritation Index of Dusantox 86 for single exposure determined in this study was PII = 0.4. According to this value the test article belongs to response category “negligible”.
- Executive summary:
The skin irritation potential of Dusantox 86 was tested in four albino rabbits. The test article was applied in a single dose to the clipped skin of experimental animals, each animal serving as its own control. A dose of 0.5 g of Dusantox 86 was pulverised, moistened with olivae oleum and applied to the intact skin of rabbits for 4 h under semi-occlusive dressings. The degree of irritation was read and scored at specified intervals (1 h, 24h, 48 h and 72h following removal of the patches) and was described to provide a complete evaluation of the effects. The Primary Irritation Index of Dusantox 86 for single exposure determined in this study was PII = 0.4. According to this value the test article belongs to response category “Negligible”.
No classification and labelling is applicable.
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