Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 229-313-2 | CAS number: 6471-49-4
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
NOAEL was estimated to be 1015 mg/kg bw when rats were orally exposed with 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide.
Thus, as per criteria of CLP regulation, 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl) diazen-1-yl]-N-(3-nitrophenyl) naphthalene-2-carboxamide can be not classified for reproductive toxicity.
Link to relevant study records
- Endpoint:
- toxicity to reproduction
- 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 the supporting QMRF report has been attached
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- Prediction is done using QSAR Toolbox version 3.3
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- Name: 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
SMILES:COc1ccc(N(=O)=O)cc1N=Nc1c2ccccc2cc(C(=O)Nc2cccc(N(=O)=O)c2)c1O
InChI:1S/C24H17N5O7/c1-36-21-10-9-17(29(34)35)13-20(21)26-27-22-18-8-3-2-5-14(18)11-19(23(22)30)24(31)25-15-6-4-7-16(12-15)28(32)33/h2-13,30H,1H3,(H,25,31)/b27-26+
Molecular Formula: C24H17N5O7
Molecular Weight: 487.4263 g/mole - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- polyethylene glycol
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 weeks prior to mating, throughout mating, and pregnancy and at least up to, and including the day before sacrifice
- Frequency of treatment:
- once daily
- Details on study schedule:
- not specified
- Dose / conc.:
- 1 015 mg/kg bw/day
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- not specified
- Positive control:
- not specified
- Parental animals: Observations and examinations:
- not specified
- Oestrous cyclicity (parental animals):
- not specified
- Sperm parameters (parental animals):
- not specified
- Litter observations:
- not specified
- Postmortem examinations (parental animals):
- not specified
- Postmortem examinations (offspring):
- not specified
- Statistics:
- not specified
- Reproductive indices:
- not specified
- Offspring viability indices:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- 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:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 1 015 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed
- Remarks on result:
- other: No effect observed
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- 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
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- 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
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not specified
- Histopathological findings:
- not examined
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- other: not specified
- Generation:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- other: not specified
- Generation:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- NOAEL was estimated to be 1015 mg/kg bw when rats were orally exposed with 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide.
- Executive summary:
In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the reproductive toxicity was estimated for 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide. The NOAEL was estimated to be 1015 mg/kg bw when rats were orally exposed with 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide.
Reference
The
prediction was based on dataset comprised from the following
descriptors: NOAEL
Estimation method: Takes average value from the 8 nearest neighbours
Domain logical expression:Result: In Domain
(((((("a"
or "b" or "c" or "d" or "e" )
and ("f"
and (
not "g")
)
)
and ("h"
and (
not "i")
)
)
and "j" )
and ("k"
and (
not "l")
)
)
and ("m"
and "n" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Non-covalent interaction AND
Non-covalent interaction >> DNA intercalation AND Non-covalent
interaction >> DNA intercalation >> DNA Intercalators with Carboxamide
Side Chain by DNA binding by OASIS v.1.3
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as SN1 AND SN1 >> Nitrenium Ion
formation AND SN1 >> Nitrenium Ion formation >> Aromatic azo AND SN1 >>
Nitrenium Ion formation >> Aromatic nitro by DNA binding by OECD
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Acylation AND Acylation >> Ester
aminolysis AND Acylation >> Ester aminolysis >> Amides by Protein
binding by OASIS v1.3
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Acylation AND Acylation >>
Direct Acylation Involving a Leaving group AND Acylation >> Direct
Acylation Involving a Leaving group >> Acetates by Protein binding by
OECD
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Amides AND Phenol Amines AND
Phenols by Aquatic toxicity classification by ECOSAR
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as SN1 AND SN1 >> Nitrenium Ion
formation AND SN1 >> Nitrenium Ion formation >> Aromatic azo AND SN1 >>
Nitrenium Ion formation >> Aromatic nitro by DNA binding by OECD
Domain
logical expression index: "g"
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 >> Alkyl phenols OR Michael addition >> P450
Mediated Activation to Quinones and Quinone-type Chemicals >>
Hydroquinones OR Michael addition >> Polarised Alkenes-Michael addition
OR Michael addition >> Polarised Alkenes-Michael addition >> Alpha,
beta- unsaturated amides OR No alert found OR SN1 >> Iminium Ion
Formation OR SN1 >> Iminium Ion Formation >> Aliphatic tertiary amines
OR SN1 >> Nitrenium Ion formation >> Unsaturated heterocyclic azo OR SN2
OR SN2 >> SN2 at an sp3 Carbon atom OR SN2 >> SN2 at an sp3 Carbon atom
>> Aliphatic halides by DNA binding by OECD
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as Known precedent reproductive and
developmental toxic potential AND NO2-alkyl/NO2-benzene derivatives (8b)
by DART scheme v.1.0
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as Not known precedent reproductive
and developmental toxic potential by DART scheme v.1.0
Domain
logical expression index: "j"
Similarity
boundary:Target:
COc1ccc(N(=O)=O)cc1N=Nc1c2ccccc2cc(C(=O)Nc2cccc(N(=O)=O)c2)c1O
Threshold=60%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization
Domain
logical expression index: "k"
Referential
boundary: The
target chemical should be classified as Alkylarylether AND Aromatic
compound AND Azo compound AND Carbonic acid derivative AND Carboxylic
acid derivative AND Carboxylic acid sec. amide AND Ether AND Hydroxy
compound AND Nitro compound AND Phenol by Organic functional groups,
Norbert Haider (checkmol)
Domain
logical expression index: "l"
Referential
boundary: The
target chemical should be classified as Heterocyclic compound by Organic
functional groups, Norbert Haider (checkmol)
Domain
logical expression index: "m"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= 3.93
Domain
logical expression index: "n"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 9.41
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 015 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is Klimisch 2 and from OECD QSAR toolbox
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproductive toxicity:
In different studies, 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl) diazen-1-yl]-N-(3-nitrophenyl) naphthalene-2-carboxamide has been investigated for reproductive oral toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rats and mice for 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide along with the study available on structurally similar read across substance CI Pigment Red 22 (2-Hydroxy-1-[(2-methyl-5-nitrophenyl)azo]-N-phenylnaphthalene-3-carboxamide) (CAS no 6448-95-9). The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies.
In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the reproductive toxicity was estimated for 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide. The NOAEL was estimated to be 1015 mg/kg bw when rats were orally exposed with 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide.
In another experimental study conducted by National Toxicology Program (National Toxicology Program. Technical Report Series. No.411, U.S. Department of commerce, National Technical Information Service 1992),F344male and female rat were treated withC.1. Pigment Red (3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide)in the concentration of 0,425, 1100 and 2100 mg/kg bw for male and 0, 500, 1300 and 2600 mg/kg/day for female orally in dietfor 2 years. The average daily ingestion of C.1. Pigment Red 23 was approximately 425, 1,100, or 2,100 mg/kg body weight per day for male rats and 500, 1,300, or 2,600 mg/kg for females. Significant increase in survival of treated male and female rats were observed at 2100 and 2600 mg/kg bw as compared to control. Significant increase in survival of treated male rats were observed at 1100 mg/kg bw as compared to control. The greater survival of the exposed groups was due principally to the chemically related decreased incidence of mononuclear cell leukemia. No clinical sign were considered to be treatment related. Significant decrease in body weights of female rats were observed at 1300 and 2600 mg/kg bw as compared to control. No effect on food consumption of treated male and female rats was observed as compared to control. In female, significant decrease in Hematocrit values, hemoglobin concentration, and erythrocyte counts at 2600 mg/kg bw as compared to control. Which indicate mild anemia. No effect in male rats was observed as compared to control. Significant increase in Serum total bilirubin were observed in female rats at 2600 mg/kg bw as compared to control. This finding coupled with the mild anemia suggests a mild hemolytic process. No effect in male rats was observed as compared to control. Similarly, at 1300 and 2600 mg/kg bw in female rats, significant increase in relative kidney and brain weight were observed. In addition, at 2100 mg/kg bw in male rats, Four renal tubule cell adenomas or carcinomas, renal tubule focal hyperplasia and renal tubule adenomas were observed. At 1100 and 2100 mg/kg bw in male rats, Four renal tubule cell adenomas or carcinomas were observed. At 2500 mg/kg bw in female rats, one renal tubule adenoma was observed. Although the trend for these renal neoplasms is significant, the incidences are low and do not exceed the historical control range of 0% to 6% in male rats. At 2100 and 2600 mg/kg bw in male and 1300 and 2600 mg/kg bw in female,significant dose-related decrease in the incidence of mononuclear cell leukemia was observed as compared to control.No significant histopathological changes were observed in reproductive organ such as testes and mammary gland of treated male and female rats as compared to control.Therefore, NOAEL was considered to be 500 mg/kg/day for P and F1 generation whenWistarmale and female rats treated withIndigo Carmineorally in dietfor 2 years. Therefore,NOAEL was considered to be 2100 mg/kg/day for male and 2600 mg/kg bw for female P generation whenF344male and female rats treated withC.1. Pigment Red (3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide) orally in dietfor 2 years.
Further supported by experimental study conducted by National Toxicology Program (National Toxicology Program. Technical Report Series. No.411, U.S. Department of commerce, National Technical Information Service 1992),B6C3F1male and female mice were treated withC.1. Pigment Red (3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide)in the concentration of 0,1,900, 4,500 and 9,500 mg/kg body/day for males and 0, 2,100, 5,240 and 10,800 mg/ kg for femalesorally in dietfor 2 years. The average daily ingestion of C.I. Pigment Red 23 was approximately 1,900, 4,500, or 9,500 mg/kg body weight per day for males and 2,100, 5,240, or 10,800 mg/kg for females. Significant decrease in survival of treated male mice were observed at 1900 mg/kg bw as compared to control. This decrease in survival was associated with evidence of trauma and secondary septicemia caused by fighting. No effect on female mice was observed as compared to control. Red stained fur, extremities, and feces were observed in treated mice. Similarly, No effect on body weight, food consumption,Hematology andClinical chemistry parameters of treated male and female rats were observed as compared to control. In addition, Increase in forestomach epithelial hyperplasia with dose were observed in male and female mice as compared to control.The presence of red pigment, presumed to be C.I. Pigment Red 23 or a metabolite, was observed within intestinal lymphoid tissue (Peyer's patches), and to a lesser extent withinmandibular and inguinal lymph nodes in mice at the 15-month interim evaluation and at the end of the 2-year study. The pigment was bright red and was observed in small intracellular granules and in largeextracellular clumps. No significant histopathological changes were observed in reproductive organ such as testes and mammary gland of treated male and female mice as compared to control. Therefore,NOAEL was considered to be 9500 mg/kg/day for male and 10800 mg/kg bw for female P generation whenB6C3F1male and femalemicetreated withC.1. Pigment Red (3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide) orally in dietfor 2 years.
Above studies are supported by experimental study conducted by J-check (Ministry of Health, Labour and Welfare", "Ministry of the Environment" and "National Institute of Technology and Evaluation, J-check, 2010) on structurally similar read across substanceCI Pigment Red 22 (2-Hydroxy-1-[(2-methyl-5-nitrophenyl)azo]-N-phenylnaphthalene-3-carboxamide) (CAS no 6448-95-9), Crj:CD(SD) male and female rats treated with CI Pigment Red 22 (2-Hydroxy-1-[(2-methyl-5-nitrophenyl)azo]-N-phenylnaphthalene-3-carboxamide) in the concentration of 0 (vehicle), 100, 300, 1000 mg/kg orally by gavage for 42 to 47 days. No effect on survival of treated male and female rat was observed as compared to control. Red feces exhibiting the same color tone as the test substance administered in all sexes were observed daily from the day following the administration start date. At 1000 mg/kg bw, in 2 male loose stools were observed transiently on 22 days after the start of administration, but abnormalities in general conditions considered to be toxic changes. No significant effect on body weight and body weight gain and food consumption of treated male and female rats were observed as compared to control. Significant decrease in prothrombin time were observed in male rats at 100 mg / kg/day, but no change was observed in the 300 and 1000 mg / kg group, so it was judged to be an accidental change. In females, there was no significant difference between the test substances administered group and the control group. Significant increase in A / G ratio were observed in male rats. At 1000 mg / kg/day However, since the total protein and albumin were not changed and were slightly high, it was considered to be fluctuating within the physiological range and it was judged that it was not caused by administration of the test substance. Significant increase in ASAT (GOT) in female rats at 100 mg / kg/day, but no change was observed in the 300 and 1000 mg / kg group, so it was judged to be an accidental change. Similarly, No effect on reproductive parameters such as sexual cycle, mating index, the fertility index, numbers of corpora lutea or implantations, the implantation index, the delivery index, the gestation index, gestation length, parturition or maternal behavior, numbers of offspring or live offspring of treated rats as compared to control. Significant increase in relative liver weight in male and absolute and relative weight in female were observed at 1000 mg / kg bw as compared to control. Significant decrease in absolute spleen weight and significant increase in relative adrenal gland weight were observed at 300 mg / kg bw in male rats. Significant increase in relative adrenal gland weight were observed in male rats at 100 mg / kg bw. But, since there was no change in the 1000 mg / kg group, it was judged to be an accidental change. Colored stomach at 1000 mg / kg and red, colored contents were observed in small intestine and large intestine at 100 mg / kg. Focal bleeding of the lung, contraction failure and white spots, stomach tar-like contents, white spots of the liver, dilation of the renal pelvic cavity, uterine bloating, vaginal distension and ventricular dilation were observed. However, since there was no certain tendency in its expression status, it was judged to be an accidental change unrelated to administration of the test substance. No histopathological changes were observed in treated male and female rats as compared to control. In addition, No effect on numbers of live offspring, clinical signs and body weight of offspring were observed as compared to control. No gross pathological changes were observed in offspring. Therefore, NOAEL was considered to be 1000 mg/kg/day for P and F1 generation when Crj:CD (SD) male and female rats treated with CI Pigment Red 22 (2-Hydroxy-1-[(2-methyl-5-nitrophenyl)azo]-N-phenylnaphthalene-3-carboxamide) orally by gavage for 42 to 47 days.
Thus, based on the above study and predictions on sodium 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl) diazen-1-yl]-N-(3-nitrophenyl) naphthalene-2-carboxamide and its read across substances, it can be concluded that NOAEL value is 1015 mg/kg bw with no effect on reproduction. Thus, as per criteria of CLP regulation, 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl) diazen-1-yl]-N-(3-nitrophenyl) naphthalene-2-carboxamide can be not classified for reproductive toxicity.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the above study and predictions on sodium 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl) diazen-1-yl]-N-(3-nitrophenyl) naphthalene-2-carboxamide and its read across substances, it can be concluded that NOAEL value is 1015 mg/kg bw with no effect on reproduction. Thus, as per criteria of CLP regulation, 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl) diazen-1-yl]-N-(3-nitrophenyl) naphthalene-2-carboxamide can be not classified for reproductive toxicity.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.