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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
Description of key information
Repeated
dose toxicity: oral
The
No Observed Effect Level (NOEL) for 4-(phenylazo)benzene-1,3-diamine in
rats is estimated to be 158.86 mg/Kg bw/day after repeated exposure via
oral route, by OECD QSAR toolbox.
Repeated
dose toxicity: inhalation
According
to Annex IX of the REACH regulation, testing by the inhalation route is
appropriate only if exposure of humans via inhalation is likely. Taking
into account the low vapour pressure of the substance
4-(phenylazo)benzene-1,3-diamine, which is reported as 0.00020265 Pa.
Thus, exposure to inhalable dust, mist and vapour of the chemical
4-(phenylazo)benzene-1,3-diamine is highly unlikely. Therefore this
study is considered for waiver.
Repeated
dose toxicity: dermal
The
acute toxicity value for 4-(phenylazo)benzene-1,3-diamine (as provided
in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the
chemical; repeated exposure by the dermal route is unlikely since the
use of gloves is common practice in industries. Thus, it is expected
that 4-(phenylazo)benzene-1,3-diamine shall not exhibit 28 day repeated
dose toxicity by the dermal route. In addition, there is no data
available that suggests that 4-(phenylazo)benzene-1,3-diamine shall
exhibit repeated dose toxicity by the dermal route. Hence this end point
was considered for waiver.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose 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 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:
- other: SD
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Frequency of treatment:
- not specified
- No. of animals per sex per dose:
- not specified
- Details on study design:
- not specified
- Positive control:
- not specified
- Observations and examinations performed and frequency:
- not specified
- Sacrifice and pathology:
- not specified
- Other examinations:
- not specified
- Statistics:
- not specified
- Clinical signs:
- 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
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 158.865 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: no significant changes were noted at mentioned dose level
- Critical effects observed:
- not specified
- Conclusions:
- The No Observed Effect Level (NOEL) for 4-(phenylazo)benzene-1,3-diamine in rats is estimated to be 158.86 mg/Kg bw/day after repeated exposure via oral route, by OECD QSAR toolbox.
- Executive summary:
Repeated dose oral toxicity was evaluated for 4-(phenylazo)benzene-1,3-diamine using SSS QSAR prediction database V3.4. The study assumed the use of rats in a subacute study. Since no significant changes were noted, the No Observed Effect Level (NOEL) for 4-(phenylazo)benzene-1,3-diamine is estimated to be 158.86 mg/Kg bw/day.
Reference
The
prediction was based on dataset comprised from the following
descriptors: NOEL
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 (
not "i")
)
)
and ("j"
and "k" )
)
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 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: "g"
Referential
boundary: The
target chemical should be classified as No alert found OR SN1 >>
Nitrenium Ion formation >> Aromatic nitro by DNA binding by OECD
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as Strong binder, NH2 group by
Estrogen Receptor Binding
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as Moderate binder, NH2 group OR
Strong binder, OH group OR Weak binder, NH2 group OR Weak binder, OH
group by Estrogen Receptor Binding
Domain
logical expression index: "j"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -2.69
Domain
logical expression index: "k"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 4.77
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 158.86 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Data is of K2 rating and is obtained from OECD QSAR toolbox.
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated
dose toxicity: oral
Predicted
data for the substance 4-(phenylazo)benzene-1,3-diamine and its
structurally related substance were reviewed for Repeated dose oral
toxicity endpoint and are represented here as weight of evidence
approach:
Repeated
dose oral toxicity was evaluated for 4-(phenylazo)benzene-1,3-diamine
using SSS QSAR prediction database V3.4. The study assumed the use of
rats in a subacute study. Since no significant changes were noted, the
No Observed Effect Level (NOEL) for 4-(phenylazo)benzene-1,3-diamine is
estimated to be 158.86 mg/Kg bw/day.
The subacute repeated dose toxicity study of structurally related
substance 2-chloro-p-phenylenediamine (CAS No. 615-66-7) in female
Sprague-Dawley rats was conducted to evaluate the adverse effects by
oral route (obtained from Fd Chem. Toxic. Vol. 22, no. 2, pp. I47 149,
1984). The test chemical was administered by oral gavage in the
concentration of 100, 200 and 400 mg/kg/day. The results showed
reduction in mean body weight gain of 200 and 400 mg/kg/day treated
rats. No mortality were observed. Clinical signs was not observed. In
addition, statistically significant increase in the number of
resorptions was observed in 400 mg/kg/day treated female rats as
compared to control. No changes were observed in gross pathology of
treated rats as compared to control. Thus, the no-observed adverse
effect level (NOAEL) of 2-chloro-p-phenylenedi amine (o-chloro-p-PD)
(CAS No. 615-66-7) in rats was considered to be 200 mg/kg/day.
Considering above data and by applying weight of evidence approach it can be concluded that the substance 4-(phenylazo)benzene-1,3-diamine will not show any effects on the specific target organ and is not toxic on Repeated exposure and hence it is considered to be not classified on Repeated exposure via oral route 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 will not show any effects on the specific target organ and is not toxic on Repeated exposure and hence it is considered to be not classified on Repeated exposure via oral route as per CLP regulation.
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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