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EC number: 299-257-1 | CAS number: 93858-25-4
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from J-check
Data source
Reference
- Reference Type:
- other:
- Title:
- Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test (OECD TG422) of Pigment Orange 13 in rats
- Author:
- J-CHECK
- Year:
- 2 010
- Bibliographic source:
- Hazard-Data Evaluation Committee of National Institute of Technology and Evaluation based on the GLP study report obtained by Japanese Ministry of Economy, Trade and Industry. Ministry of Economy, Trade and Industry, Japan, 2010
Materials and methods
Test guideline
- 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:
- Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test (OECD TG422) of Pigment Orange 13 in rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one]
- EC Number:
- 222-530-3
- EC Name:
- 4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one]
- Cas Number:
- 3520-72-7
- Molecular formula:
- C32H24Cl2N8O2
- IUPAC Name:
- 4,4'-(1E,1'E)-(3,3'-dichlorobiphenyl-4,4'-diyl)bis(diazene-2,1-diyl)bis(3-methyl-1-phenyl-1H-pyrazol-5(4H)-one)
- Details on test material:
- - Name of test material (as cited in study report): Pigment Orange 13
- Molecular formula (if other than submission substance): C32H24Cl2N8O2
- Molecular weight (if other than submission substance): 623.5016 g/mole
- Substance type: Organic
- Physical state: Orange powder
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Pigment Orange 13
- Molecular formula (if other than submission substance): C32H24Cl2N8O2
- Molecular weight (if other than submission substance): 623.5016 g/mole
- Substance type: Organic
- Physical state: Orange powder
- Impurities (identity and concentrations): < 1%
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: (P) x wks; (F1) x wks: 9 weeks old
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- 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:
- - Male: 42 days
- Female: 41 - 47 days (from 14 days before mating to day 4 of lactation) - Frequency of treatment:
- Daily
- Details on study schedule:
- Not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 40 mg/kg bw/day
- Dose / conc.:
- 200 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- Total: 116
For male
0 mg/kg/day: 12 male, 12 female
40 mg/kg/day: 12 male, 12 female
200 mg/kg/day: 12 male, 12 female
1000 mg/kg/day: 12 male, 12 female
Recovery
0 mg/kg/day: 5 male, 5 female
1000 mg/kg/day: 5 male, 5 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not specified
- Positive control:
- Not specified
Examinations
- Parental animals: Observations and examinations:
- Survival, Clinical sign, Body weight and weight gain, food consumption, urinalysis, Hematology and clinical chemistry were examined.
- Oestrous cyclicity (parental animals):
- Estrous cycle was examined.
- Sperm parameters (parental animals):
- Not specified
- Litter observations:
- Mortality, Sex ratio or body weight on day 0 and 4 of lactation, or viability
- Postmortem examinations (parental animals):
- Organ weight, Gross pathology and histopathology was examined.
- Postmortem examinations (offspring):
- External and macroscopic abnormalities were examined.
- Statistics:
- Not specified
- Reproductive indices:
- Copulation index, fertility index, or pairing days until copulation, delivery index, birth index, live birth index and viability index were observed.
- Offspring viability indices:
- viability index on day 0 and 4
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical sign were observed during the study in treated rats.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality were observed in treated male and female rats as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No significant effect on body weight gain of male and female rats was observed as compared to control.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effect on food consumption of treated male and female rat was observed as compared to control.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No effect on hematology of treated male and female rat was observed as compared to control.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No effect on Clinical chemistry of treated male and female rat was observed as compared to control.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No changes in urinalysis were observed in treated rats as compared to control.
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- No changes in reflex/reaction, grip strength, or locomotor activity were observed in treated male and femlae rats as compared to control.
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No effect on organ weight of treated male and female rat was observed as compared to control.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No effect on estrous cycle, number of corpora lutea or implantations was observed in treated rats as compared to control.
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effect on Copulation index, fertility index, or pairing days until copulation, delivery index was observed in treated rats as compared to control.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- haematology
- clinical biochemistry
- urinalysis
- organ weights and organ / body weight ratios
- histopathology: non-neoplastic
- reproductive function (oestrous cycle)
- reproductive performance
- Remarks on result:
- other: No effect observed
Target system / organ toxicity (P0)
- 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
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effect on viability of pups were observed on day 0 and 4 as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect on body weight of pups were observed on day 0 and 4 as compared to control.
- 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:
- no effects observed
- Description (incidence and severity):
- No external abnormality were observed in pups as compared to control.
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- No histopathological abnormality were observed in pups as compared to control.
- Other effects:
- no effects observed
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- no effects observed
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- no effects observed
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- body weight and weight gain
- gross pathology
- histopathology: non-neoplastic
- Remarks on result:
- other: No effect obseved
Target system / organ toxicity (F1)
- 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
Overall reproductive toxicity
- 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
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1000 mg/kg bw for P and F1 generation when Crl:CD(SD) male and female rats were treated with Pigment Orange 13 orally by gavage for 47 days.
- Executive summary:
In a Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test,Crl:CD(SD) male and female rats were treated with Pigment Orange 13 in the concentration of0, 40, 200, 1000 mg/kg bw/day orally by gavage for 41 - 47 days (from 14 days before mating to day 4 of lactation. No mortality, Clinical signs, behavior modification,change in Body weight and Food consumption of treated rats were observed as compared to control. Similarly, No significant effect on Urinalysis, Hematology, Blood chemistry, Organ weight and Histopathology of treated rat were observed as compared to control rats. In addition, no effect on reproductive parameters of treated rats were observed such as estrous cycle, number of corpora lutea or implantations, Copulation index, fertility index, or pairing days until copulation and delivery index of treated rat as compared to control.No effect on organ weight and histopathological changes were observed in treated male and female rats as compared to control.No effect on viability of pups and body weight were observed on day 0 and 4 as compared to control. No external and histopathological abnormality and were observed in pups as compared to control. Therefore, NOAEL was considered to be 1000 mg/kg bw for P and F1 generation when Crl:CD(SD) male and female rats were treated with Pigment Orange 13 orally by gavage for 47 days.
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