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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
Skin Irritation:
Signs of irritation were not observed when Basic red 12 was applied to rabbit skin, it can be considered to be not irritating to skin.
Eye Irritation:
Signs of irritation were observed when Basic red 12 was instilled to rabbit eyes, it can be considered to be irritating to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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 journals
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- To assess the skin irritation potential of Basic Red 12 in rabbits
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):C.I. Basic Red 12
- IUPAC name: 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
- 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:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data available
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- no data available
- Duration of treatment / exposure:
- no data available
- Observation period:
- no data available
- Number of animals:
- no data available
- Details on study design:
- Scoring system: + = irritant; - = not irritating
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: no data available
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- no signs of irritation observed
- Interpretation of results:
- other: not irritating
- Conclusions:
- Since no reactions were observed when Basic red 12 was applied to rabbit skin, it can be considered to be not irritating to skin.
- Executive summary:
The dermal irritation potential of Basic Red 12 was assessed in rabbits according to OECD 404 Guidelines.
Basic Red 12 was applied to the skin of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.
Since no reactions were observed when Basic red 12 was applied to rabbit skin, it can be considered to be not irritating to skin.
Reference
List of colorants to be classified as toxic
C.I Generic Name |
CAS Number |
CAS NAME |
Active ingredient* in test sample (%) |
Irritation**
|
Symbol |
R phrase |
S phrase |
|
Skin [rabbits] |
Eye [rabbits] |
|||||||
C.I Basic Red 12 C.I 48070 |
6320-14-5 |
3H-Indolium,2-[3-(1,3-dihydro-1,3,3- trimethyl-2H-indol-2-ylidine)-1-propenyl]- 1,3,3-trimethyl-,chloride |
>98 |
- |
+ |
T |
25, 41 |
22 , 26, 44 |
*- The purified test samples contained water and such inert ingredients as sodium chloride, sodium sulphate. etc.
** - Based on test procedures according to OECD guidelines for testing of chemicals: 'Acute oral toxicity' (No. 401), 'Acute dermal irritation/corrosion' (No 404) and 'Acute eye irritation/corrosion' (No. 405)
Risk (R) Phrases
23 -toxic by inhalation
24 - toxic in contact with skin
25-toxic if swallowed
33 -danger of cumulative effects
36-irritating to eyes
41-risk of serious damage to eyes
Safety(S)phrases
22-do not breathe dust
26-incase of contact with eyes, rinse immediately with plenty of water and seek medical advice
28 - after contact with skin, wash immediately with plenty of soap and water
36 -wear suitable protective clothing
37-wear suitable gloves
44 - if you feel unwell seek medical advice (show the label if possible)
+ = irritant;- =non-irritant
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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 journals
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- To assess the eye irritation potential of Basic Red 12 in rabbits
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - IUPAC name: 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
- 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:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data available
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- no data available
- Observation period (in vivo):
- no data available
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- no data available
- Details on study design:
- Scoring system: + = irritant; - = not irritating
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: no data available
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- signs of irritation observed
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Signs of irritation were observed when Basic red 12 was instilled to rabbit eyes, it can be considered to be irritating to eyes.
- Executive summary:
The ocular irritation potential of Basic Red 12 was assessed in rabbits according to OECD 405 Guidelines.
Basic Red 12 was instilled into the eyes of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.
Signs of irritation were observed when Basic red 12 was instilled to rabbit eyes, it can be considered to be irritating to eyes.
Reference
List of colorants to be classified as toxic
C.I Generic Name |
CAS Number |
CAS NAME |
Active ingredient* in test sample (%) |
Irritation**
|
Symbol |
R phrase |
S phrase |
|
Skin [rabbits] |
Eye [rabbits] |
|||||||
C.I Basic Red 12 C.I 48070 |
6320-14-5 |
3H-Indolium,2-[3-(1,3-dihydro-1,3,3- trimethyl-2H-indol-2-ylidine)-1-propenyl]- 1,3,3-trimethyl-,chloride |
>98 |
- |
+ |
T |
25, 41 |
22 , 26, 44 |
*- The purified test samples contained water and such inert ingredients as sodium chloride, sodium sulphate. etc.
** - Based on test procedures according to OECD guidelines for testing of chemicals: 'Acute oral toxicity' (No. 401), 'Acute dermal irritation/corrosion' (No 404) and 'Acute eye irritation/corrosion' (No. 405)
Risk (R) Phrases
23 -toxic by inhalation
24 - toxic in contact with skin
25-toxic if swallowed
33 -danger of cumulative effects
36-irritating to eyes
41-risk of serious damage to eyes
Safety(S)phrases
22-do not breathe dust
26-incase of contact with eyes, rinse immediately with plenty of water and seek medical advice
28 - after contact with skin, wash immediately with plenty of soap and water
36 -wear suitable protective clothing
37-wear suitable gloves
44 - if you feel unwell seek medical advice (show the label if possible)
+ = irritant;- =non-irritant
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
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 chloridehas been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with predicted data for target chemical and its structurally similar read across chemicals.
The dermal irritation potential of Basic Red 12 was assessed in rabbits according to OECD 404 Guidelines.
Basic Red 12 was applied to the skin of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.
Since no reactions were observed when Basic red 12 was applied to rabbit skin, it can be considered to be not irritating to skin.
This is supported by studies performed to determine the dermal irritation potential of the structurally similar read across chemicals. Both the chemicals were applied to the skin of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.
Since no reactions were observed when both the chemicals were applied to rabbit skin, they can be considered to be not irritating to skin.
Based on the available data for the target as well read across chemicals, and applying the weight of evidence approach, Basic Red 12 can be considered to be not irritating to skin.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.
Eye Irritation:
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 chloridehas been investigated for potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with predicted data for target chemical and its structurally similar read across chemicals.
The ocular irritation potential of Basic Red 12 was assessed in rabbits according to OECD 405 Guidelines.
Basic Red 12 was instilled into the eyes of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -=not irritating and + = irritating.
Signs of irritation were observed when Basic red 12 was instilled to rabbit eyes, it can be considered to be irritating to eyes.
This is supported by the experimental study performed in albino Vienna White rabbits according to Draize method to assess the ocular irritation potential of the structurally similar read across chemical.
0.1 ml undiluted test chemical was instilled into the eyes of 3 albino Vienna White rabbits. The rabbits were observed from1, 24, 48, 72 hours till 8 days after application of test chemical.The ocular lesions observed were scored according to the method of Draize. The Mean score after 8 days was 46.
Based on the score, test chemical was considered to be moderately to severely irritating to eyes.
The above studies are further supported by studies performed to determine the ocular irritation potential of the structurally similar read across chemicals. Both the chemicals were instilled into the eyes of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.
Since signs of irritation were observed when both the chemicals were instilled into rabbit eyes, they can be considered to be irritating to eyes.
Based on the available data for the target as well read across chemicals, and applying the weight of evidence approach, Basic Red 12 can be considered to be irritating to eyes.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Category 2”.
Justification for classification or non-classification
Based on the available studies for Basic Red 12, it is likely to cause irritation to eyes but will not cause any irritation to skin.
Hence, Basic Red 12 can be classified under the category "Category 2" for eye irritation and "Not Classified" for skin irritation as per CLP regulation.
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.
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