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EC number: 286-282-8 | CAS number: 85203-90-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- 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 from secondary source
Data source
Reference
- Reference Type:
- other: J-check
- Title:
- Combined Repeat Dose and Reproductive / Developmental Toxicity Screening Test of test matrial by Oral Administration in Rats
- Author:
- National Institute of Technology and Evaluation
- Year:
- 2 018
- Bibliographic source:
- Japanese Chemical Collaborative Knowledge Database, 2018
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Test Guideline 422.
- Principles of method if other than guideline:
- Combined repeated dose toxicity study with reproduction and developmental screening of test material in rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 3-hydroxy-4-[(2-methyl-5-nitrophenyl)azo]-N-phenylnaphthalene-2-carboxamide
- EC Number:
- 229-245-3
- EC Name:
- 3-hydroxy-4-[(2-methyl-5-nitrophenyl)azo]-N-phenylnaphthalene-2-carboxamide
- Cas Number:
- 6448-95-9
- Molecular formula:
- C24H18N4O4
- IUPAC Name:
- 3-hydroxy-4-[(2-methyl-5-nitrophenyl)diazenyl]-N-phenyl-2-naphthamide
- Details on test material:
- - Name of test material (as cited in study report):C.I. Pigment Red 22- Molecular formula :C24H18N4O4- Molecular weight :426.43 g/mole - Substance type:Organic- Physical state:Solid- purity:> 99 %
Constituent 1
- Specific details on test material used for the study:
- No data available
Test animals
- Species:
- rat
- Strain:
- other: Crj:CD(SD)IGS
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % Sodium carboxymethylcellulose mixed with 0.1 % Tween 80
- Details on exposure:
- Details on exposurePREPARATION OF DOSING SOLUTIONS: The test material mixed with 0.5 % Sodium carboxymethylcellulose mixed with 0.1 % Tween 80DIET PREPARATION- Rate of preparation of diet (frequency):No data available- Mixing appropriate amounts with (Type of food):No data available- Storage temperature of food:No data availableVEHICLE- Justification for use and choice of vehicle (if other than water): The test material mixed with 0.5 % Sodium carboxymethylcellulose mixed with 0.1 % Tween 80- Concentration in vehicle: 0 (vehicle), 100, 300, 1000 mg/kg- Amount of vehicle (if gavage):No data available- Lot/batch no. (if required):No data available- Purity:No data available
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- No data available
- Duration of treatment / exposure:
- Males, 37 daysFemales, from 14 days before mating to day 4 of lactation
- Frequency of treatment:
- Daily
- Duration of test:
- Approx 60 days
Doses / concentrations
- Remarks:
- 0 (vehicle), 100, 300, 1000 mg/kg
- No. of animals per sex per dose:
- Total: 960 mg/kg bw/day: 12 male, 12 female 100 mg/kg bw/day: 12 male, 12 female 100 mg/kg bw/day: 12 male, 12 female 1000 mg/kg bw/day: 12 male, 12 female
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes - Time schedule: - Cage side observations checked in table [No.?] were included. DETAILED CLINICAL OBSERVATIONS: Yes - Time schedule: BODY WEIGHT: Yes - Time schedule for examinations: 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 / No / No data - Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data - Time schedule for examinations: POST-MORTEM EXAMINATIONS: yes - Sacrifice on gestation day:day 5 of lactation - Organs examined: numbers of corpora lutea or implantations OTHER:
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes Examinations included: - Gravid uterus weight: No data - Number of corpora lutea: Yes - Number of implantations: Yes - Number of early resorptions: No data - Number of late resorptions: No data - Other:
- Fetal examinations:
- - External examinations: Yes: - Soft tissue examinations: Yes: [all per litter / half per litter / #? per litter ] / No / No data - Skeletal examinations: Yes: [all per litter / half per litter / #? per litter ] / No / No data - Head examinations: Yes: [all per litter / half per litter / #? per litter ] / No / No data
- Statistics:
- No data available
- Indices:
- reproductive parameters such as the mating index, the fertility index, the implantation index, the delivery index, the gestation index,the live birth index, the viability index were observed
- Historical control data:
- No data available
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- 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:
- no effects observed
- 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:
- effects observed, non-treatment-related
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- not specified
- Other effects:
- not specified
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: overall no effects on reproductive parameters
- Remarks on result:
- other: overall no effects on reproductive parameters
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Skeletal malformations:
- not specified
- Visceral malformations:
- not specified
- Other effects:
- not specified
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- reduction in number of live offspring
- external malformations
- other: overall no effects on developmental parameters
- Remarks on result:
- other: overall no effects on developmental parameters
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Relation to maternal toxicity:
- 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/day as no developmental toxic effects were observed ,when Crj:CD(SD)IGS male and female rats were treated with test material orally by gavage.
- Executive summary:
In a combined repeated dose toxicity study with reproduction and developmental screening, of test material was performed according to OECD Test Guideline 422.Crj:CD(SD)IGS male and female rats were treated with test material in the concentration of 0, 100, 300, 1000 mg/kg bw/day in 0.5 % Sodium carboxymethylcellulose mixed with 0.1 % Tween 80 orally by gavage.12 male and 12 female were placed in each group.Males were exposed with test chemical for 37 days while Females, from 14 days before mating to day 4 of lactation.Clinical sign, body weight, food consumption were observed. On day 38 male rats were killed while female onday 5 of lactation.
No effect on clinical sign, body weight, food consumption, haematology and clinical chemistry of treated rats as compared to control. Similarly, no significant effect on mating index, fertility index, numbers of corpora lutea or implantations, implantation index, delivery index, gestation index, gestation length, parturition or maternal behaviour were observed in treated rats. Increase in liver weight was observed in male and female rats. No gross pathological and histopathological changes were observed in treated rats. In addition, no significant effect on mating index, fertility index, numbers of corpora lutea or implantations implantation index, delivery index, gestation index, gestation length, parturition or maternal behaviour and numbers of offspring or live offspring, sex ratio, live birth index, viability index or body weights of offspring were observed. No gross pathological changes were observed in offspring as compared to control. Therefore, NOAEL was considered to be 1000 mg/kg bw/day ,when Crj:CD(SD)IGS male and female rats were treated with test material orally by gavage.
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