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EC number: 228-668-0 | CAS number: 6320-14-5
- 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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity:
In Acute oral toxicity,LD50 value for target substance 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5) was considered to be 31 mg/kg bw and 25 mg/kg bw in males and females rats respectively and 18 mg/kg bw in rats in another experimental study. All these studies concluded that the LD50 value is between 5-50 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5) can be classified as “Category II” for acute oral toxicity.
Acute Inhalation Toxicity:
1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5) has very low vapour pressure (1.42e-011Pa= 1.06509e-13 mmHg).So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer-reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Acute Oral toxicity test was carried out to study the effects of 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5) on rats.
- GLP compliance:
- not specified
- Test type:
- other: no data available
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):C.I. Basic Red 12
- Molecular formula :C25H29N2.Cl
- Molecular weight :392.971 g/mol
- Substance type:organic
- Physical state:No data
- Purity :>98%
- Impurities (identity and concentrations):<2% (The purified test samples contained water and such inert ingredients as sodium chloride, sodium sulphate. etc.) - Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- No data available
- Doses:
- 25 mg/kg bw and 31 mg/kg bw
- No. of animals per sex per dose:
- No data available
- Control animals:
- not specified
- Details on study design:
- Details on study design
- Duration of observation period following administration: 14 days - Statistics:
- No data available
- Preliminary study:
- No data available
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 25 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality was observed at dose 25 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 31 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality was observed at dose 31 mg/kg bw
- Mortality:
- 50% mortality was observed at dose 25 mg/kg bw and 31 mg/kg bw
- Clinical signs:
- other: No data available
- Gross pathology:
- No data available
- Other findings:
- No data available
- Interpretation of results:
- Category 2 based on GHS criteria
- Conclusions:
- The lethal concentration (LD50) value for acute oral toxicity test was considered to be 25 mg/kg bw in female rats and 31 mg/kg bw in male rats ,when rats were treated with 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5) orally according to OECD Guideline 401 (Acute Oral toxicity).
- Executive summary:
Acute oral toxicity study was performed in rats using test material 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride(6320-14-5).50% mortality was observed at dose 25 and 31 mg/kg bw. Hence,LD50 value was considered to be 25 mg/kg bw in female rats and 31 mg/kg bw in male rats,when rats were treated with 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride(6320-14-5) orally according to OECD Guideline 401 (Acute Oral toxicity).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 31 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from peer-reviewed journal
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Quality of whole database:
- Waiver
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute Oral Toxicity:
In different studies, 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5) has been investigated for acute oral toxicity to a greater or lesser extent. Often the studies are based on in vivo experimental data in rodents, i.e. most commonly in rats for 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5) .The studies are summarized as below –
In experimental study conducted by R Anliker et. al. (Journal of the Society of Dyers and Colourists, Volume 104 May/June 1988,223-225) and Chittaradan Desai (Ecological and toxicological properties of dyestuffs, Chittaradan Desai,Colourage,December 1992,page No. 51-54) for the target substance 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5). Acute oral toxicity study was performed in rats using test material 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride(6320-14-5).50% mortality was observed at dose 25 and 31 mg/kg bw. Hence,LD50 value was considered to be 25 mg/kg bw in female rats and 31 mg/kg bw in male rats,when rats were treated with 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride(6320-14-5) orally according to OECD Guideline 401 (Acute Oral toxicity).
Also these results are further supported by the experimental study conducted by U.S. National Library of Medicine (Chemidplus Database,U.S. National Library of Medicine,2017) andRTECS(RTECS (registry of toxic effect of chemical substance database ), 2018) for thetarget substance 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5). Acute oral toxicity study was performed in rats using test material 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride(6320-14-5).50% mortality was observed at dose 18 mg/kg bw. Hence,LD50 value was considered to be 18 mg/kg bw,when rats were treated with 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride(6320-14-5) orally.
Thus, based on the above studies on target substance 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5), it can be concluded that LD50 value is between 5-50 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5) can be classified as “Category II” for acute oral toxicity.
Acute Inhalation Toxicity:
1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5) has very low vapour pressure (1.42e-011Pa= 1.06509e-13 mmHg).So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver.
Justification for classification or non-classification
Based on the above experimental studies on 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5), it can be concluded that LD50 value is between 5-50 mg/kg bw for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5) can be classified as “Category II” for acute oral toxicity.For Acute inhalation toxicity wavier was added so, not possible to classify.
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