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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
Endpoint summary
Administrative data
Description of key information
Acute Oral Toxicity:
Acute oral toxicity dose was predicted based on OECD QSAR toolbox for target substance 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2)was estimated to be 4929.75 mg/kg bw on rats and for it’s closely related read across substance 1-Methylpiperazine (109-01-3) was considered to be 2830 mg/kg bw and for it’s functionally similar read across substance Tetrasodium 4-acetamido-5-hydroxy-6-({7-sulfonato-4-[(4-sulfonatophenyl)diazenyl]-1-naphthyl}diazenyl)naphthalene-1,7-disulfonate (2519-30-4) was considered to be >2000 mg/kg bw.All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) can be classified as category V of acute oral toxicity.
Acute Inhalation Toxicity:
5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride has very low vapor pressure (2.31E-007 Pa), 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 this end point for repeated inhalation toxicity was considered for waiver.
Acute Dermal Toxicity:
Acute dermal toxicity dose was predicted based on OECD QSAR toolbox for target substance 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) was estimated to be 3767.01mg/kg bw and for different studies available on structurally similar read across substance2-[[4-(Dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride (77061-58-6) was considered to be >2000 mg/kg bw and 2-[(4-Aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride (97404-02-9) was considered to be >2000 mg/kg bw.All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) can be classified as category V of acute dermal toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Data is predicted using OECD QSAR toolbox version 3.3 and QMRF report has been attached
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Prediction was done by using OECD QSAR toolbox v3.3,2017
- GLP compliance:
- not specified
- Test type:
- other: estimated data
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of the test material: 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride
- IUPAC name: 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride
- Molecular formula: C18H21N6Cl
- Moleclar weight: 356.8589 g/mol
- Substance type: Organic
- Smiles: Cc1cn[n+](n1/N=N/c2ccc(cc2)N(C)Cc3ccccc3)C.[Cl-]
- Inchi: 1S/C18H21N6.ClH/c1-15-13-19-23(3)24(15)21-20-17-9-11-18(12-10-17)22(2)14-16-7-5-4-6-8-16;/h4-13H,14H2,1-3H3;1H/q+1;/p-1/b21-20+; - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- No data available
- Doses:
- 4929.75 mg/kg bw
- No. of animals per sex per dose:
- No data available
- Control animals:
- not specified
- Details on study design:
- No data available
- Statistics:
- No data available
- Preliminary study:
- No data available
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 929.75 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality was observed
- Mortality:
- No data available
- Clinical signs:
- other: No data available
- Gross pathology:
- No data available
- Other findings:
- No data available
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 was estimated to be 4929.75 mg/kg bw,when male and female wistar rats were orally exposed with 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) via gavage.
- Executive summary:
In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute oral toxicity was estimated for 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2).The LD50 was estimated to be 4929.75 mg/kg bw,when male and female wistar rats were orally exposed with 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) via gavage.
Reference
The
prediction was based on dataset comprised from the following
descriptors: LD50
Estimation method: Takes average value from the 8 nearest neighbours
Domain logical expression:Result: In Domain
(((((((((((((("a"
or "b" )
and "c" )
and "d" )
and ("e"
and (
not "f")
)
)
and ("g"
and (
not "h")
)
)
and ("i"
and (
not "j")
)
)
and "k" )
and ("l"
and (
not "m")
)
)
and ("n"
and (
not "o")
)
)
and ("p"
and (
not "q")
)
)
and ("r"
and (
not "s")
)
)
and ("t"
and (
not "u")
)
)
and "v" )
and ("w"
and "x" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Michael addition OR Michael
addition >> P450 Mediated Activation to Quinones and Quinone-type
Chemicals OR Michael addition >> P450 Mediated Activation to Quinones
and Quinone-type Chemicals >> Arenes OR SN1 OR SN1 >> Iminium Ion
Formation OR SN1 >> Iminium Ion Formation >> Aliphatic tertiary amines
OR SN1 >> Nitrenium Ion formation OR SN1 >> Nitrenium Ion formation >>
Aromatic azo OR SN1 >> Nitrenium Ion formation >> Tertiary aromatic
amine OR SN1 >> Nitrenium Ion formation >> Unsaturated heterocyclic azo
by DNA binding by OECD ONLY
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as Aliphatic Amines by Aquatic
toxicity classification by ECOSAR
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as No alert found by DNA binding by
OASIS v.1.3 ONLY
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Michael addition AND Michael
addition >> P450 Mediated Activation to Quinones and Quinone-type
Chemicals AND Michael addition >> P450 Mediated Activation to Quinones
and Quinone-type Chemicals >> Arenes AND SN1 AND SN1 >> Iminium Ion
Formation AND SN1 >> Iminium Ion Formation >> Aliphatic tertiary amines
AND SN1 >> Nitrenium Ion formation AND SN1 >> Nitrenium Ion formation >>
Aromatic azo AND SN1 >> Nitrenium Ion formation >> Tertiary aromatic
amine AND SN1 >> Nitrenium Ion formation >> Unsaturated heterocyclic azo
by DNA binding by OECD ONLY
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Non binder, without OH or NH2
group by Estrogen Receptor Binding
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as Non binder, impaired OH or NH2
group OR Non binder, MW>500 OR Non binder, non cyclic structure OR
Strong binder, OH group OR Very strong binder, OH group OR Weak binder,
OH group by Estrogen Receptor Binding
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OASIS v1.3
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Direct
acylation involving a leaving group OR Acylation >> Direct acylation
involving a leaving group >> Carbamates OR Acylation >> Ester
aminolysis OR Acylation >> Ester aminolysis >> Amides OR Acylation >>
Ester aminolysis >> Dithiocarbamates OR Acylation >> Ester aminolysis or
thiolysis OR Acylation >> Ester aminolysis or thiolysis >> Activated
aryl esters OR Acylation >> Ring opening acylation OR Acylation >> Ring
opening acylation >> beta-Lactams OR Nucleophilic addition OR
Nucleophilic addition >> Addition to carbon-hetero double bonds OR
Nucleophilic addition >> Addition to carbon-hetero double bonds >>
Ketones OR SN2 OR SN2 >> Nucleophilic substitution at sp3 carbon atom OR
SN2 >> Nucleophilic substitution at sp3 carbon atom >> Alkyl halides OR
SN2 >> Nucleophilic substitution at sp3 carbon atom >> alpha-Activated
haloalkanes OR SN2 >> Nucleophilic substitution on benzilyc carbon atom
OR SN2 >> Nucleophilic substitution on benzilyc carbon atom >>
alpha-Activated benzyls OR SN2 >> SN2 Reaction at a sp3 carbon atom OR
SN2 >> SN2 Reaction at a sp3 carbon atom >> Activated alkyl esters and
thioesters by Protein binding by OASIS v1.3
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OECD
Domain
logical expression index: "j"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Direct
Acylation Involving a Leaving group OR Acylation >> Direct Acylation
Involving a Leaving group >> Acetates OR Acylation >> Direct Acylation
Involving a Leaving group >> Azlactone by Protein binding by OECD
Domain
logical expression index: "k"
Referential
boundary: The
target chemical should be classified as Bioavailable by Lipinski Rule
Oasis ONLY
Domain
logical expression index: "l"
Referential
boundary: The
target chemical should be classified as Halogens AND Non-Metals by
Groups of elements
Domain
logical expression index: "m"
Referential
boundary: The
target chemical should be classified as Alkali Earth OR Metalloids by
Groups of elements
Domain
logical expression index: "n"
Referential
boundary: The
target chemical should be classified as Group 14 - Carbon C AND Group 15
- Nitrogen N AND Group 17 - Halogens Cl AND Group 17 - Halogens
F,Cl,Br,I,At by Chemical elements
Domain
logical expression index: "o"
Referential
boundary: The
target chemical should be classified as Group 16 - Oxygen O OR Group 16
- Sulfur S OR Group 17 - Halogens F by Chemical elements
Domain
logical expression index: "p"
Referential
boundary: The
target chemical should be classified as Inclusion rules not met by Skin
irritation/corrosion Inclusion rules by BfR
Domain
logical expression index: "q"
Referential
boundary: The
target chemical should be classified as Primary and secondary aliphatic
amines OR Quaternary organic ammonium compounds OR Tertiary aliphatic
amine by Skin irritation/corrosion Inclusion rules by BfR
Domain
logical expression index: "r"
Referential
boundary: The
target chemical should be classified as (!Undefined)Group All Lipid
Solubility < 0.01 g/kg AND (!Undefined)Group CN Lipid Solubility < 0.4
g/kg AND Group All Melting Point > 200 C AND Group CN Melting Point >
180 C AND Group CN Molecular Weight > 290 g/mol AND Group CN Vapour
Pressure < 0.001 Pa by Skin irritation/corrosion Exclusion rules by BfR
Domain
logical expression index: "s"
Referential
boundary: The
target chemical should be classified as (!Undefined)Group C Surface
Tension > 62 mN/m OR (!Undefined)Group CNHal Lipid Solubility < 4 g/kg
OR (!Undefined)Group CNHal Lipid Solubility < 400 g/kg OR Group All log
Kow < -3.1 OR Group C Aqueous Solubility < 0.0001 g/L OR Group CN
Aqueous Solubility < 0.1 g/L by Skin irritation/corrosion Exclusion
rules by BfR
Domain
logical expression index: "t"
Referential
boundary: The
target chemical should be classified as H-acceptor-path3-H-acceptor by
in vivo mutagenicity (Micronucleus) alerts by ISS
Domain
logical expression index: "u"
Referential
boundary: The
target chemical should be classified as Aromatic mono- and dialkylamine
OR No alert found by in vivo mutagenicity (Micronucleus) alerts by ISS
Domain
logical expression index: "v"
Similarity
boundary:Target:
CN{+}1(.Cl{-})C(N=Nc2ccc(N(C)Cc3ccccc3)cc2)N(C)C=N1
Threshold=20%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization
Domain
logical expression index: "w"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -1.57
Domain
logical expression index: "x"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 1.15
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 929.75 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from QSAR toolbox 3.3
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 adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 767.01 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from QSAR toolbox 3.3
Additional information
Acute Oral Toxicity:
In different studies, 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) has been investigated for acute oral toxicity to a greater or lesser extent. Often the studies are based on in vivo experiments and estimated data in rodents, i.e. most commonly in rats for 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) along with the study available on it’s closely related read across substance 1-Methylpiperazine (109-01-3) and it’s functionally similar read across substance Tetrasodium 4-acetamido-5-hydroxy-6-({7-sulfonato-4-[(4-sulfonatophenyl)diazenyl]-1-naphthyl}diazenyl)naphthalene-1,7-disulfonate (2519-30-4). The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies. The studies are summarized as below –
In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute oral toxicity was estimated for 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2).The LD50 was estimated to be 4929.75 mg/kg bw,when male and female wistar rats were orally exposed with 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) via gavage.
The above study was further supported by Henry F. Smyth et. al. (American Industrial Hygiene Association Journal, 23:2,pg 95-107, 1962) and U.S. National Library of Medicine (Chemidplus Database,U.S. National Library of Medicine,2017) it’s closely related read across substance 1-Methylpiperazine (109-01-3). Acute oral toxicity study was done in groups of 5 non-fasted,Carworth-Wistar malerats using test material 1-Methylpiperazine(109-01-3) following 14 days of observation period.50% mortality was observed in treated rats at 2830 mg/kg bw.Hence,LD50 value was considered to be 2830 mg/kg bw,when rats were treated with 1-Methylpiperazine(109-01-3)orally by gastric intubation.
This is further supported by I. F. Gaunt et. al. (Fd Cosmet. Toxtcol. Vol. 5, pp. 171-177,1967)for it’s functionally similar read across substance Tetrasodium 4-acetamido-5-hydroxy-6-({7-sulfonato-4-[(4-sulfonatophenyl)diazenyl]-1-naphthyl}diazenyl)naphthalene-1,7-disulfonate (2519-30-4). Acute oral toxicity study was done in group of 10 ICI Alderley Park Strain 1 SPF male and female mice using test material Tetrasodium 4-acetamido-5-hydroxy-6-({7-sulfonato-4-[(4-sulfonatophenyl)diazenyl]-1-naphthyl}diazenyl)naphthalene-1,7-disulfonate(2519-30-4).No mortality was observed at dose 2000 mg/kg bw.In clinical signs examination, substantial amounts of coloured material was excreted in the faeces.Hence,LD50 value was considered to be >2000 mg/kg bw,when mice were treated with Tetrasodium 4-acetamido-5-hydroxy-6-({7-sulfonato-4-[(4-sulfonatophenyl)diazenyl]-1-naphthyl}diazenyl)naphthalene-1,7-disulfonate(2519-30-4) orally.
Thus, based on the above studies on 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) and it’s closely related and functionally related read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) can be classified as category V of acute oral toxicity.
Acute Inhalation Toxicity:
5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride has very low vapor pressure (2.31E-007 Pa), 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 this end point for repeated inhalation toxicity was considered for waiver.
Acute Dermal Toxicity:
In different studies, 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) has been investigated for acute oral toxicity to a greater or lesser extent. Often the studies are based on in vivo experiments and estimated data in rodents, i.e. most commonly in rabbits for 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) along with the study available on structurally similar read across substance2-[[4-(Dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride (77061-58-6) and 2-[(4-Aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride (97404-02-9).The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies. The studies are summarized as below –
In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute dermal toxicity was estimated for 1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate (29508-47-2).The LD50 was estimated to be 3767.01mg/kg bw,when male and female Vienna White rabbits were exposed occlusively with 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) by dermal application for 24 hours.
The above study was further supported by Scientific Committee on Consumer Products – SCCP (Scientific Committee on Consumer Products – SCCP, COLIPA n° B116, during the 10th plenary meeting of 22 March 2011) and Scientific Committee on Consumer Products – SCCP (Scientific Committee on Consumer Products – SCCP, during the 25th plenary meeting of 20 October 2003) for the structurally similar read across substance2-[[4-(Dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride (77061-58-6).In acute dermal toxicity study,10 males and 10 females Crl:CD (SD)IGS BR rats were occlusively treated with Basic Red 51(77061-58-6)in the concentration of 2000 mg/kg bw by dermal application following 14 days of observation period. The test material was moistened with distilled water.The untreated skin of each animal served as the control.The hair was clipped the day prior to the experiment. It was applied to the clipped area as a thin uniform layer from scapula to iliac crest and half way down the flank on each side of the animal’s back. The area was occluded for 24 hrs.The initial dermal irritation was scored and recorded 30 minutes after bandage removal on Day 1.No mortality was observed in treated rats at dose 2000 mg/kg bw.Signs of clinical toxicity included chromodacryorrhea and/or red nasal discharge. Findings were first noted 4 hours post-dose and were resolved by Day 2. Signs of dermal irritation included desquamation (slight scaling) in all males on Day 3 and in one male and one female on Day 7. There were no signs of dermal irritation at any observation interval in any of the remaining animals.All animals gained weight during the course of the study. No visible lesions were noted in any of the animals at necropsy.Therefore, LD50 value was considered to be >2000 mg/kg bw,when rats were treated with Basic Red 51(77061-58-6)by dermal application.
Also these results are further supported by Scientific Committee on Consumer Safety (SCCS) (Scientific Committee on Consumer Safety (SCCS), COLIPA n° B118,during the 13th plenary meeting of 13-14 December 2011); Scientific Committee on Consumer Safety (SCCS) (Scientific Committee on Consumer Safety (SCCS), COLIPA n° B118,during the 9th plenary meeting on 14 December 2010) and Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) (Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP), during the 25th plenary meeting of 20 October 2003) for the structurally similar read across substance2-[(4-Aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride (97404-02-9).Acute dermal toxicity study was done in Sprague Dawley Crl : CD (SD)IGS BR rats using test material 2-[(4-Aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride(97404-02-9) according to the OECD guideline 402(acute dermal toxicity).The test material was moistened with distilled water.The hair was clipped the day prior to the experiment. It was applied to the clipped area as a thin uniform layer to approximately 10% of the body surface area from scapula to iliac crest and half way down the flank on each side of the animal’s back. The area was occluded for 24 h. The initial dermal irritation was scored and recorded 30 minutes after bandage removal on Day 1. The untreated skin of each animal served as the control. Additional dermal irritation readings were performed for each animal on Days 3, 7, 10, and 14.No Mortality was observed at dose2000 mg/kg bw.All animals showed clinical signs of toxicity including chromodacryorrhea and red nasal discharge on the day of dosing and observation Day 1. All signs of toxicity were resolved at day 2. Body weight gain was not affected during the study and necropsy did not reveal observable changes.A curtailed gross examination of the cervical, thoracic, and abdominal viscera was performed.No irritation was noted throughout the study Hence,LD50 value was considered to be >2000 mg/kg bw,when rats were occlusively treated with2-[(4-Aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride(97404-02-9)by dermal application for 24 hoursfollowing 14 days of observation period.
Thus, based on the above studies on 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) and it’s structurally similar read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) can be classified as category V of acute dermal toxicity.
Justification for classification or non-classification
Based on the above studies and prediction on 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) and it’s closely related , functionally related and structurally similar read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) can be classified as category V for acute oral and dermal toxicity. For Acute inhalation toxicity wavier was added so, not possible to classify.
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