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EC number: 212-668-2 | CAS number: 842-07-9
- 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
The reproductive toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017) with respect to the descriptor log Kow; to evaluate the toxic effects of administration of1-phenylazo-2-naphthol(CAS No.842 -07 -9) in rat by the oral route. No adverse effects was observed. Therefore, the no observed adverse effect level (NOAEL) of1-phenylazo-2-naphtholfor reproductive toxicity study was estimated to be 1000.0 mg/kg bw/day.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- 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:
- Prediction is done using OECD QSAR toolbox version 3.3 and the supporting QMRF report has been attached.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Prediction is done using OECD QSAR Toolbox version 3.3 with respect to the descriptor log Kow.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- F0-males: - for 2 weeks prior to mating, throughout mating and after mating at least until the minimum total dosing period of 28 days had been completed
F0-females:2 weeks prior to mating, throughout mating, and pregnancy and at least up to, and including the day before sacrifice. - Frequency of treatment:
- Daily
Doses / - Dose / conc.:
- 1 000 mg/kg bw/day
- Control animals:
- not specified
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations:No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- 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
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OTHER
MORTALITY: Mortality was observed. - Postmortem examinations (parental animals):
- GROSS NECROPSY: Yes
HISTOPATHOLOGY / ORGAN WEIGHTS: Yes - Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- 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
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- gross pathology
- histopathology: non-neoplastic
- other: Did not revealed any treatment-related findings on parental animals.
- Critical effects observed:
- no
- 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
- Remarks on result:
- not measured/tested
- Critical effects observed:
- not specified
- Reproductive effects observed:
- no
- Conclusions:
- The no observed adverse effect level (NOAEL) of 1-phenylazo-2-naphthol for reproductive toxicity study was estimated to be 1000.0 mg/kg bw/day.
- Executive summary:
The reproductive toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017) with respect to the descriptor log Kow; to evaluate the toxic effects of administration of 1-phenylazo-2-naphthol (CAS No.842 -07 -9) in rat by the oral route. No adverse effects was observed. Therefore, the no observed adverse effect level (NOAEL) of 1-phenylazo-2-naphthol for reproductive toxicity study was estimated to be 1000.0 mg/kg bw/day.
Reference
The
prediction was based on dataset comprised from the following
descriptors: NOAEL
Estimation method: Takes average value from the 6 nearest neighbours
Domain logical expression:Result: In Domain
(((((((("a"
or "b" or "c" )
and ("d"
and (
not "e")
)
)
and "f" )
and "g" )
and ("h"
and (
not "i")
)
)
and ("j"
and (
not "k")
)
)
and ("l"
and (
not "m")
)
)
and ("n"
and "o" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as SN1 AND SN1 >> Nitrenium Ion
formation AND SN1 >> Nitrenium Ion formation >> Aromatic azo by DNA
binding by OECD
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as Strong binder, OH group by
Estrogen Receptor Binding
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Phenols by Aquatic toxicity
classification by ECOSAR
Domain
logical expression index: "d"
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: "e"
Referential
boundary: The
target chemical should be classified as Inorganic chemical OR Known
precedent reproductive and developmental toxic potential OR
NO2-alkyl/NO2-benzene derivatives (8b) OR Non-steroid nucleus derived
estrogen receptor (ER) and androgen receptor (AR) OR Non-steroid nucleus
derived estrogen receptor (ER) and androgen receptor (AR) >>
4-alkylphenol-like derivatives (2b-3) OR Not covered by current version
of the decision tree OR Organophosphorus compounds (1b) OR
Polyhalogenated benzene derivatives (8c) OR Toluene and small alkyl
toluene derivatives (8a) by DART scheme v.1.0
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as Not bioavailable by Lipinski
Rule Oasis ONLY
Domain
logical expression index: "g"
Similarity
boundary:Target:
Oc1ccc2ccccc2c1N=Nc1ccccc1
Threshold=40%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as No alert found by rtER Expert
System ver.1 - USEPA
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as Alkylphenols OR Salicylates by
rtER Expert System ver.1 - USEPA
Domain
logical expression index: "j"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding alerts for skin sensitization by OASIS v1.3
Domain
logical expression index: "k"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Ester
aminolysis OR Acylation >> Ester aminolysis >> Amides OR Schiff base
formation OR Schiff base formation >> Pyrazolones and Pyrazolidinones
derivatives OR Schiff base formation >> Pyrazolones and Pyrazolidinones
derivatives >> Pyrazolones and Pyrazolidinones by Protein binding
alerts for skin sensitization by OASIS v1.3
Domain
logical expression index: "l"
Referential
boundary: The
target chemical should be classified as Aromatic diazo AND
H-acceptor-path3-H-acceptor by in vivo mutagenicity (Micronucleus)
alerts by ISS
Domain
logical expression index: "m"
Referential
boundary: The
target chemical should be classified as alpha,beta-unsaturated carbonyls
by in vivo mutagenicity (Micronucleus) alerts by ISS
Domain
logical expression index: "n"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= 3.34
Domain
logical expression index: "o"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 8.2
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The data is Klimicsh 2 and from OECD QSAR toolbox version 3.3 (2017).
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Various studies including predicted results from the validated model and experimental study has been investigated for reproductive toxicity to a greater or lesser extent for the test chemical 1-phenylazo-2-naphthol (CAS No. 842-07-9) along with its structurally similar read across substance 1-(2,4-dimethylphenylazo)-2-naphthol (CAS No.- 3118-97-6) . The predicted data for target chemical 1-phenylazo-2-naphthol (CAS No. 842-07-9) has been compared with experimental study for a read across substance. The studies are summarized as below:
The reproductive toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017) with respect to the descriptor log Kow; to evaluate the toxic effects of administration of 1-phenylazo-2-naphthol (CAS No.842 -07 -9) in rat by the oral route. No adverse effects was observed. Therefore, the no observed adverse effect level (NOAEL) of 1-phenylazo-2-naphthol for reproductive toxicity study was estimated to be 1000.0 mg/kg bw/day.
The above study is supported by the read across substance 1-(2,4-dimethylphenylazo)-2-naphthol (CAS No.- 3118-97-6) study. The reproductive toxicity study was performed byM. G. ALLMARKet al. (J. Pharma. Pharmacology; Vol. 8, Pg. no. 417-424, 1956) to evaluate the toxic effects of administration of 1-(2,4-dimethylphenylazo)-2-naphthol on rat. When the rats are exposed orally (gavage) to the test substance 1-(2,4-dimethylphenylazo)-2-naphthol (Sudan II) for 20 weeks at a dose conc. of 200 and 400 mg/kg bw/day, no adverse effects were observed at a dose level of 200 mg/kg bw/day. Testicular changes are observed in animals receiving the higher concentrations i.e; 400 mg/kg bw/day. A significant decline in blood haemoglobin values was found in all groups of both sexes at the dose level of both 200 and 400 mg/kg bw/day. Food consumption and food efficiency was affected by the test substance at the dose level of 400 mg/kg bw/day. In a number of cases the organ weights were about the same as the controls but the body weights of the test animals were less than the controls, suggesting the possible utilization of muscle protein. In other cases the body weights of test and control animals were about the same but the organ weights differed significantly. By the end of 20 weeks, 6 male rats receiving a dose of 200 mg/kg bw/day had died whereas all 10 female rats has survived for 20 weeks. However, 5 male and 3 female rats receiving a dose of 400 mg/kg bw/day had died by the end of the experiment. A detailed examination was made of the haematoxylin-eosin stained paraffin sections of a number of organs including lung, heart, liver, spleen, thyroid, pancreas, stomach, small intestine, kidney, urinary bladder, adrenal, testes, ovaries and thymus. Heart, liver, spleen, kidneys and testes were the organs chiefly affected. No consistent histopathological changes were observed in the tissues or organs of the test animal. Testicular changes are observed in animals receiving the higher concentrations. Therefore, no adverse effects level of 1-(2,4-dimethylphenylazo)-2-naphthol (Sudan II) in rats were observed at a dose level of 200 mg/kg bw/day. Hence, 1-(2,4-dimethylphenylazo)-2-naphthol (Sudan II) is not considered to be a reprotoxic for male and female rats at a dose level of 200 mg/kg bw/day.
Moreover, in the same study by M. G. ALLMARKet al. (J. Pharma. Pharmacology; Vol. 8, Pg. no. 417-424, 1956) for read across substance 1-(2,4-dimethylphenylazo)-2-naphthol (CAS No. 3118-97-6), the reproductive toxicity effects of 1-(2,4-dimethylphenylazo)-2-naphthol (FD&C Red No. 32) in young male and female rats by an oral route for 44 weeks was investigated. The rats were exposed by oral feed for 44 week to the concentrations of 0, 30,75 and 1500 mg/kgbw/day. No mortality was obserserved at the dose level of 30mg/kg bw/day in treated group compared to control. Mortality was observed ,by the end of 20 weeks in all the rats on the 1500 mg/kg bw/day level. Mortality was also observed ,by the end of 40 weeks in all the rats on the 75 mg/kg bw/day. No significant change were observed in clinical sign, body weight, food consumption , food efficiency, hematology, reproductive fuction , gross pathology and histopathology of male and female rats obserserved at the dose level of 30mg/kg bw/day in treated group compared to control. Therefore NOAEL was considered to be 30mg/kg bw/day for 1-(2,4-dimethylph enylazo)-2-naphthol (FD&C Red No. 32) in male and female rats by an oral route for 44 weeks.
Based on the above mentioned studies for target substance and to its read across substance by applying weight of evidence approach and also according to CLP criteria, it can be concluded that no adverse effects on sexual function and fertility was observed, therefore the substance 1-phenylazo-2-naphthol (CAS No. 842-07-9) cannot be classified as reproductive toxicant.
Justification for classification or non-classification
Based on the available data for the assessment of reproductive toxicity and following CLP Regulation EC No. 1272/2008 no classification of 1-phenylazo- 2-naphthol (CAS No.842-07-9) as reproductive toxicant is warranted.
Additional information
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