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EC number: 207-803-7 | CAS number: 495-54-5
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
Toxicity
to reproduction:
Since
no significant changes were noted relating to effects on reproductive
toxicity in rats, the No Observed Adverse Effect Level (NOAEL) for
4-(phenylazo)benzene-1,3-diamine is estimated to be 605.025 mg/Kg
bw/day, by OECD QSAR toolbox.
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 by OECD QSAR Toolbox version 3.4. The supporting QMRF report has been attached
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Data is predicted by OECD QSAR Toolbox version 3.4 with logPow as the primary descriptor
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- not specified
- Details on mating procedure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- not specified
- Frequency of treatment:
- not specified
- Details on study schedule:
- not specified
- No. of animals per sex per dose:
- not specified
- 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:
- 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:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 605.025 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- reproductive performance
- other: no significant changes were noted at mentioned dose level
- Remarks on result:
- other: other details not specified
- Critical effects observed:
- not specified
- Mortality / viability:
- no mortality observed
- Dose descriptor:
- other: not specified
- Remarks on result:
- other: not specified
- Critical effects observed:
- not specified
- Reproductive effects observed:
- not specified
- Conclusions:
- Since no significant changes were noted relating to effects on reproductive toxicity in rats, the No Observed Adverse Effect Level (NOAEL) for 4-(phenylazo)benzene-1,3-diamine is estimated to be 605.025 mg/Kg bw/day, by OECD QSAR toolbox.
- Executive summary:
Toxicity to reproduction was evaluated for 4-(phenylazo)benzene-1,3-diamineu sing SSS QSAR prediction database V3.4. The study assumed the use of rats in a subacute study. Since no significant changes were noted relating to effects on reproductive toxicity in rats, the No Observed Adverse Effect Level (NOAEL) for 4-(phenylazo)benzene-1,3-diamine is estimated to be 605.025 mg/Kg bw/day.
Reference
The
prediction was based on dataset comprised from the following
descriptors: NOAEL
Estimation method: Takes average value from the 5 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 "i" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Anilines (Acute toxicity) by
US-EPA New Chemical Categories
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 >> Primary aromatic amine by DNA binding by OECD
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Strong binder, NH2 group by
Estrogen Receptor Binding
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as AN2 AND AN2 >> Michael-type
addition to quinoid structures AND AN2 >> Michael-type addition to
quinoid structures >> Substituted Anilines by Protein binding by OASIS
v1.4
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Anilines (amino-meta) AND
Anilines (Unhindered) by Aquatic toxicity classification by ECOSAR
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as Strong binder, NH2 group by
Estrogen Receptor Binding
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as Moderate binder, NH2 group OR
Non binder, MW>500 OR Weak binder, NH2 group by Estrogen Receptor Binding
Domain
logical expression index: "h"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -1.43
Domain
logical expression index: "i"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 6.84
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 605.025 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Data is of K2 reliability and is obtained 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
Toxicity
to reproduction:
Predicted
data for the substance 4-(phenylazo)benzene-1,3-diamine and its read
across substance were reviewed for toxicity to reproduction endpoint and
are represented here as weight of evidence approach:
Toxicity to reproduction was evaluated for 4-(phenylazo)benzene-1,3-diamineu sing SSS QSAR prediction database V3.4. The study assumed the use of rats in a subacute study. Since no significant changes were noted relating to effects on reproductive toxicity in rats, the No Observed Adverse Effect Level (NOAEL) for 4-(phenylazo)benzene-1,3-diamine is estimated to be 605.025 mg/Kg bw/day.
In a reproductive toxicity study (Fd. Chem. Toxic. Vol. 22, no. 2, pp. I47 149, 1984), female Sprague-Dawley rat were exposed to structurally related substance 2-chloro-p-phenylenediamine (o-chloro-p-PD; CAS 615-66-7) orally in the concentration 0, 100, 200 and 400 mg/kg/day. In the parental generation, decreased in mean body weight were obsrved in 200 and 400 mg/kg/day treated rat as compared to control . In addition,significant increase in the number of resorptions were observed in female rat. Effect on fetal weight was observed when treated with 400 mg/kg/day. Therefore, NOAEL is considered to be 100 mg/kg/day for F0 generation and 200 mg/kg/day for F1 generation when rats are exposed to 2-chloro-p-phenylene diamine (o-chloro-p-PD) orally for 10 days.
Considering above data and by applying weight of evidence approach it can be concluded that the substance 4-(phenylazo)benzene-1,3-diamine did not showed any major effects on reproduction and hence it is considered to be not classified for Reproductive toxicity as per CLP regulation.
Justification for classification or non-classification
Considering above data and by applying weight of evidence approach it can be concluded that the substance 4-(phenylazo)benzene-1,3-diamine did not showed any major effects on reproduction and hence it is considered to be not classified for Reproductive toxicity as per CLP regulation.
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.
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