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EC number: 265-449-9 | CAS number: 65113-55-5
- 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:
- key study
- Study period:
- From 2011-12-06 to 2011-12-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
Test material
- Reference substance name:
- [4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate
- EC Number:
- 265-449-9
- EC Name:
- [4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate
- Cas Number:
- 65113-55-5
- Molecular formula:
- C25H30N3.C18H14N3O3S
- IUPAC Name:
- [4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate
- Test material form:
- solid: particulate/powder
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: Elevage JANVIER (53940 Le Genest St Isle - FRANCE)
- Age at study initiation: MALE: 8 weeks old. FEMALE: 9 weeks old
- Weight at study initiation: MALE : from 265 g to 290 g. FEMALE: from 210 g to 242 g
- Housing: During the treatment, the animals were kept in individual cages. On D1, the animals were put into their cage by 5, in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet (e.g. ad libitum): ad libitum (foodstuff: M20-SDS)
- Water (e.g. ad libitum): ad libitum (tap water from public distribution system)
- Acclimation period: of at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 25°C
- Humidity (%): 30% to 70%
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 dark/12 light
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- paraffin oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure:dorsal area of the trunk
- % coverage: at least 10% of the body surface cleared for the application of the test item
- Type of wrap if used: porous gauze dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing with liquid paraffin
- Time after start of exposure: After 24 hours exposure period
TEST MATERIAL
- Concentration (if solution): 2000 mg/L
- Constant volume or concentration used: yes
- For solids, paste formed: no
VEHICULE - Duration of exposure:
- Exposure period of 24 hours
- Doses:
- Group 1: 2000 mg/kg
Group 2: 2000 mg/kg - No. of animals per sex per dose:
- Group 1: 5 male rats
Group 2: 5 female rats - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily examination (spontaneous activity, preyer's reflex, respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex, back hair appearance). Weighing on days D0 (before administration of th test item), D2, D7 and D14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Macroscopic examinations at the end of the study (after anaesthesia) with the examination of organs likely to be modified in cases of acute toxicity (oesophagus, stomach, the entire digestiv tract, spleen, liver, thymus, trachea, lungs, heart, kidneyx, urinary bladder, testicules, skin of the treatment area, adrenals, pancreas).
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the study
- Clinical signs:
- other: No clinical sign was observed. A slight black coloration of the treatment site was noted in all animals on D1.
- Gross pathology:
- No gross pathology was observed.
Any other information on results incl. tables
Current control study: The study identified TAD-PH-11/0623 was performed to assess the behaviour of the strain of rat used at this laboratory in its environment and to give additional historical data. The study was performed from 25 October 2011 to 08 November 2011.
the method was designed to meet the requirements of the following: OECED guideline for the testing of chemicals N°402 dated February 24thn, 1987 and the method B3 of the Council regulation N°440/2008.
Test item: Liquid paraffin
METHODS:
Ten aminals, five males and five females, received by topical administration, an effective dose of 10 ml/kg body weight of the control item liquid paraffin, under porous gauze dressing, during 24 hours.
RESULTS:
Clinical examinations: Nothing to report. Animal normal (10/10)
Bodyweight evolution: Normal throught the study
Necropsy: No treatment related changes were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in the rat in both sex.
According to the criteria for the classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C directives 67/548, 2001/59 and 99/45, the test item must not be classified. No symbol or risk phrase is required.
In accordance with the Regulation EC n°1272/2008, the test item must not be classified. No signal word or hazard statement is required. - Executive summary:
The test item was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n° 402 dated February 24th, 1987 and the test method B.3. of the Council regulation n°440/2008 of 30 May 2008.
No mortality occured during the study.
No systemic clinical sign related to the administration of the test item was observed. A slight black coloration of the treatment site was noted in all animals on day 1.
The body weight evolution of the animals remained normal throughout the study.
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
In conclusion, the LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in the rat in both sex.
According to the criteria for the classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C directives 67/548, 2001/59 and 99/45, the test item must not be classified. No symbol or risk phrase is required.
In accordance with the Regulation EC n°1272/2008, the test item must not be classified. No signal word or hazard statement is required.
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