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EC number: 249-670-8 | CAS number: 29508-47-2
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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 from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Opinion on: Basic Red 51 (COLIPA n° B116)
- Author:
- European Commission (EC) - Scientific Committee on Consumer Safety (SCCS)
- Year:
- 2 010
- Bibliographic source:
- Basic Red 51 (COLIPA n° B116) SCCS/1332/10
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Teratogenicity study of Basic Red 51 was performed on wistar rats via oral gavage for Days 6 to 17 post coitum.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride
- EC Number:
- 278-601-4
- EC Name:
- 2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride
- Cas Number:
- 77061-58-6
- Molecular formula:
- C13H18N5.Cl
- IUPAC Name:
- 2-[[4-(Dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride
- Details on test material:
- - Name of test material (IUPAC name): 2-[[4-(Dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride
- Common name: Basic Red 51
- Molecular formula: C13H18N5.Cl
- Molecular weight: 279.773 g/mol
- Smiles notation: c1([n+](ccn1C)C)\N=N\c1ccc(cc1)N(C)C.[ClH-]
- InChl: 1S/C13H18N5.ClH/c1-16(2)12-7-5-11(6-8-12)14-15-13-17(3)9-10-18(13)4;/h5-10H,1-4H3;1H/q+1;/p-1
- Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (IUPAC name): 2-[[4-(Dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride
- Common name: Basic Red 51
- Molecular formula: C13H18N5.Cl
- Molecular weight: 279.773 g/mol
- Smiles notation: c1([n+](ccn1C)C)\N=N\c1ccc(cc1)N(C)C.[ClH-]
- InChl: 1S/C13H18N5.ClH/c1-16(2)12-7-5-11(6-8-12)14-15-13-17(3)9-10-18(13)4;/h5-10H,1-4H3;1H/q+1;/p-1
- Substance type: Organic
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- (Hanlbm (SPF))
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Double distilled water
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS:
The test material diluted with Double distilled water
DIET PREPARATION
- Rate of preparation of diet (frequency):
- Mixing appropriate amounts with (Type of food ):
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle: 0, 20, 60 and 180 mg/kg bw/day
- Amount of vehicle (if gavage): 10ml/kg
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Mated female used
- Duration of treatment / exposure:
- 11 days (Days 6 to 17 post coitum)
- Frequency of treatment:
- once a daily
- Duration of test:
- No data available
Doses / concentrations
- Remarks:
- 0, 20, 60 and 180 mg/kg bw/day
- No. of animals per sex per dose:
- Total:240
0 mg/kg bw:22 female
20 mg/kg bw:22 female
60 mg/kg bw:22 female
180 mg/kg bw:22 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
Examinations
- Maternal examinations:
- Parental animals observation and examinations
CAGE SIDE OBSERVATIONS: yes
DETAILED CLINICAL OBSERVATIONS: Yes
Time schedule: Clinical observations and mortality were recorded at least twice daily.
BODY WEIGHT: Yes
Time schedule for examinations: body weight was recorded daily from day 0 until day 21 post coitum.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes Food consumption was recorded for the following periods: days 0-6, 6-12, 12-18 and 18-21 post coitum;
Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
Time schedule for examinations:
OTHER: - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: No data
- Number of late resorptions: No data
- Other:The uteri of all females with live foetuses were weighed at necropsy on day 21 post coitum; - Fetal examinations:
- - External examinations: Yes
- Soft tissue examinations: No data
- Skeletal examinations: Yes
- Head examinations: No data - Statistics:
- No data available
- Indices:
- No data available
- Historical control data:
- No data available
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Clinical signs of toxicity or reactions to treatment did not occur in any group.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- Maternal deaths did not occur during the study
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The mean body weight gain was reduced only in the 180 mg/kg bw/day dose group, these data being correlated with the decreased food consumption
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- A dose-dependent reduction of the food consumption was observed during the treatment period in the 60 and 180 mg/kg bw/day dose groups (-7.6% and -23.5% respectively); an increase of + 5.5 % was observed in the 180 mg/kg bw/day dose group after the treatment period.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- Mean post-implantation loss was similar between treated and control dams in the 60 and 180 mg/kg bw/day dose groups.The increased post-implantation loss observed only in the 60 mg/kg bw/day dose group was considered to be incidental. No abnormal findings were noted in any female of any treated group.
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- The mean number of foetuses per dam was similar between treated and control dams in the 60 and 180 mg/kg bw/day dose groups.
Effect levels (maternal animals)
- Dose descriptor:
- NOEL
- Effect level:
- 20 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- mortality
- pre and post implantation loss
- Remarks on result:
- other: No treatment related effets was observed
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- The mean foetal body weights were similar in all groups except for a slight increase observed in the 60 mg/kg bw/day dose group, which was attributed to the slightly reduced mean number of foetuses per dam.
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified - Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- The sex ratio for foetuses was similar in all groups
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- not specified
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the 20 mg/kg bw/day dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls.
- Visceral malformations:
- not specified
- Other effects:
- not specified
Effect levels (fetuses)
- Dose descriptor:
- NOEL
- Effect level:
- 180 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- changes in sex ratio
- fetal/pup body weight changes
- skeletal malformations
- Remarks on result:
- other: No overall developmental effects was observed
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In developmental toxicity study, the NOEL was considered to be for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day ,The test material did not affects reproductive parameter and not toxic to embryo or foetus. When mated female wistar rats treated with Basic Red 51 (77061-58-6) via oral gavage for Days 6 to 17 post coitum
- Executive summary:
The developmental toxicity study of Basic Red 51 (77061-58-6) was performed on mated female wistar (Hanlbm (SPF) rats according to OECD 414.22 mated female per dose group were administered with 10ml /kg aqueous solution of test material in dose concentration0, 20, 60 and 180 mg/kg bw/dayonce daily for 11 days (Days 6 to 17 post coitum).While The control group received only the vehicle (double distilled water).Food consumption was recorded for the following periods: days 0-6, 6-12, 12-18 and 18-21 post coitum; body weight was recorded daily from day 0 until day 21 post coitum. Clinical observations and mortality were recorded at least twice daily. At post mortem, on day 21, necropsy, all internal organs were examined with emphasis on the uterus, uterine contents, position of foetuses in the uterus and number of corpora lutea. The uteri of all females with live foetuses were weighed at necropsy on day 21 post coitum; the foetuses were removed from the uterus, weighed, sexed, and examined for gross external abnormalities.
Maternal deaths did not occur during the study and clinical signs of toxicity or reactions to treatment did not occur in any group. A dose-dependent reduction of the food consumption was observed during the treatment period in the mid- and high-dose groups (-7.6% and - 23.5% respectively); an increase of + 5.5 % was observed in the high dose group after the treatment period. The mean body weight gain was reduced only in the high dose group, these data being correlated with the decreased food consumption. Mean post-implantation loss and mean number of foetuses per dam were similar between treated and control dams in the low- and mid-dose groups. The increased post-implantation loss observed only in the mid dose group was considered to be incidental. No abnormal findings were noted in any female of any treated group. The mean foetal body weights were similar in all groups except for a slight increase observed in the mid-dose group, which was attributed to the slightly reduced mean number of foetuses per dam. The sex ratio for foetuses was similar in all groups. Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Hencethe NOEL was considered to befor the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day ,The test material did not affects reproductive parameter and not toxic to embryo or foetus.When mated female wistar rats treated with Basic Red 51 (77061-58-6)via oral gavage for Days 6 to 17 post coitum
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