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EC number: 235-424-7 | CAS number: 12224-98-5
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Robust Summary & Test Plans: Color Former Category: Robust Summary
- Author:
- U.S. Environmental Protection Agency
- Year:
- 2 003
- Bibliographic source:
- Robust Summary & Test Plans: Color Former Category: Robust Summary, EPA HPV Challenge Color Former Category,2 May 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Acute dermal toxicity study of 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran (36431-22-8) was performed in rats.
- GLP compliance:
- not specified
- Test type:
- other: no data available
- Limit test:
- yes
Test material
- Reference substance name:
- 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran
- Cas Number:
- 36431-22-8
- Molecular formula:
- C33H32N2O3
- IUPAC Name:
- 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran
- Details on test material:
- - Name of test material (IUPAC name): 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran
- Common name: Black XV
- Molecular formula: C33H32N2O3
- Molecular weight: 504.627 g/mol
- Smiles notation: O=C1O[C@@]2(c3c(Oc4c2ccc(N(CC)CC)c4)cc(C)c(Nc2c(C)cc(C)cc2)c3)c2c1cccc2
-InChl:1S/C33H32N2O3/c1-6-35(7-2)23-13-14-26-31(18-23)37-30-17-22(5)29(34-28-15-12-20(3)16-21(28)4)19-27(30)33(26)25-11-9-8-10-24(25)32(36)38-33/h8-19,34H,6-7H2,1-5H3
- Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):Black XV
- Molecular formula :C33H32N2O3
- Molecular weight :504.627 g/mol
- Substance type:organic
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Age at study initiation: Ten to fourteen weeks old
- Weight at study initiation:
male :210 - 227 grams,
female :200 - 207 grams
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: test material was applied uniformly to an area of shorn skin
- % coverage: approximating to 10% of the total body surface area
- Type of wrap if used: selfadhesive bandage (Hypertie).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the area wiped with cotton wool moistened with arachis oil B.P. to remove any residual test material.
- Time after start of exposure: 24 hours - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Total:10 animals
2000 mg/kg bw:5 male and 5 female - Control animals:
- not specified
- Details on study design:
- Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: Individual body weights were recorded on the day of treatment and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: Observed over 14 days with deaths and overt signs of toxicity recorded at 1/2, 1,2 and 4 hours after dosing and subsequently once daily for 14 days - Statistics:
- No data available
Results and discussion
- Preliminary study:
- No data available
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed at dose 2000 mg/kg bw
- Mortality:
- no mortality was observed at dose 2000 mg/kg bw
- Clinical signs:
- other: No signs of systemic toxicity or skin irritation were noted during the study.
- Gross pathology:
- No abnormalities were noted at necropsy of animals killed at the end of the study.
- Other findings:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute dermal median lethal dose (LD50) of the 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran (36431-22-8) in the Sprague-Dawley rat was considered to be >2000 mg/kg bodyweight according to OECD Guideline 402 (Acute Dermal Toxicity).
- Executive summary:
In acute dermal toxicity study, 10 male and female Sprague-Dawley rat were treated with 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran (36431-22-8) in the concentration of 2000 mg/kg bw by dermal applicationaccording to OECD Guideline 402 (Acute Dermal Toxicity).Undiluted test material was used. Skin of animals were moistened with arachis oil B.P. The appropriate amount of test material, as received,was pre-weighed into a glass vial, and applied uniformly to an area of shorn skin approximating to 10% of the total body surface area which had been previously moistened with arachis oil B.P. A piece of surgical gauze measuring 7 cm x 4 cm was placed over the treatment area and semi-occluded with a piece of selfadhesive bandage (Hypertie) for 24 hours. After the 24 contact period the bandage was removed and the area wiped with cotton wool moistened with arachis oil B.P. to remove any residual test material. signs of toxicity recorded at 1/2, 1,2 and 4 hours after dosing and subsequently once daily for 14 days. Individual body weights were recorded on the day of treatment and on days 7 and 14.No mortality was observed in treated rats at dose 2000 mg/kg bw.No signs of systemic toxicity or skin irritation were noted during the study. No toxicologically significant effects on bodyweight were noted in the males during the study. One female showed bodyweight loss during the study. No abnormalities were noted at necropsy of animals killed at the end of the study.Therefore, LD50 value was considered to be >2000 mg/kg bw,when rats were treated with 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran (36431-22-8)by dermal application.
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