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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

Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from peer-reviewed publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- CHRONIC TOXICITY STUDIES ON FOOD COLOURS. PART II. OBSERVATIONS ON THE TOXICITY OF FD & C GREEN NO. 2 (LIGHT GREEN SF YELLOWISH), FD & C ORANGE NO. 2 (ORANGE SS) AND FD & C RED NO. 32 (OIL RED XO) IN RATS.
- Author:
- M. G. ALLMARK, H. C. GRICE AND W. A. MANNELL
- Year:
- 1 956
- Bibliographic source:
- J. Pharma. Pharmacology; Vol. 8, Pg. no. 417-424, 1956
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The reproductive toxicity study was conducted to evaluate the toxic effects of administration of 1-(2,4-dimethylphenylazo)-2-naphthol (Sudan II) in rats for 20 weeks.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 1-(2,4-dimethylphenylazo)-2-naphthol
- EC Number:
- 221-490-4
- EC Name:
- 1-(2,4-dimethylphenylazo)-2-naphthol
- Cas Number:
- 3118-97-6
- Molecular formula:
- C18H16N2O
- IUPAC Name:
- 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report):FD&C Red No. 32.
- Molecular formula: C18H16N2O
- Molecular weight : 276.337 g/mol
- Substance type: Organic
- Physical state: Solid
- Smiles : Cc1ccc(N=Nc2c(O)ccc3ccccc23)c(C)c1
- InChI: 1S/C18H16N2O/c1-12-7-9-16(13(2)11-12)19-20-18-15-6-4-3-5-14(15)8-10-17(18)21/h3-11,21H,1-2H3/b20-19+
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 1-(2,4-dimethylphenylazo)-2-naphthol (C.I. Solvent orange 7/Sudan II)
- Molecular formula: C18H16N2O
- Molecular weight: 276.337 g/mol
- Substance type: Organic
- Physical state: Solid
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation: 5 to 6 weeks
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: Rats were kept in groups of two in a cage.
- Use of restrainers for preventing ingestion (if dermal): No data available
- Diet (e.g. ad libitum): Diet ad libitum
- Water (e.g. ad libitum): Water ad libitum
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: No data available
Administration / exposure
- 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:
- 20 weeks (More than 4 months)
- Frequency of treatment:
- Daily
- Details on study schedule:
- Not specified.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 400 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10 animals/sex/dose in treated group
10 control animals were used for study. - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not specified.
- Positive control:
- Not specified.
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data available
- Cage side observations checked in table [No.?] were included: No data available
DETAILED CLINICAL OBSERVATIONS: No data available
- Time schedule: No data available
BODY WEIGHT: Yes
- Time schedule for examinations: Body weight of the test animal was recorded weekly.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes, food consumption of the test animal was recorded weekly.
- 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: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
- Time schedule for examinations: No data available
OTHER:
Food efficiency of the test animal was also recorded weekly. For more accurate evaluation of food consumption it would have been preferable to place only one rat in a cage, but this was not possible.
Haematology determinations were made for 20 weeks on groups of male and female rats.
A slight modification of the pyridine-haemochromogen method of Rimington was used and the mean values of the final determinations were made. Blood haemoglobin parameter was examined.
Organs of surviving rats were weighed at the termination of the test. The mean weight in mg/g of body weight was calculated.
Mortality was observed. - Oestrous cyclicity (parental animals):
- Not specified
- Sperm parameters (parental animals):
- Sperm parameters (parent animal)
Parameters examined in [all/P] male parental generations: A detailed examination was made of the haematoxylin-eosin stained paraffinsections of testes. - Litter observations:
- Not specified
- Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals [describe when, e.g. as soon as possible after the last litters in each generation were produced.]: No data available
- Maternal animals: All surviving animals [describe when, e.g. after the last litter of each generation was weaned.]: No data available
- Other: Post-mortem examinations were made where possible on rats which died on test. All surviving rats were killed at the end of the experiments and post-mortem examinations were made.
GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]: No data available
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively: Yes, many of the organs were weighed and prepared for histological examination.
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. - Postmortem examinations (offspring):
- Not applicable
- Statistics:
- Standard deviation was observed.
- Reproductive indices:
- Not specified
- Offspring viability indices:
- Not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 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. - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- In a number of cases the body weights of the test animals were less than the controls. In other cases the body weights of test and control animals were about the same.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food consumption was affected by the test substance at the dose level of 400 mg/kg bw/day.
- Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- Food efficiencey was affected by the test substance at the dose level of 400 mg/kg bw/day.
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 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. This same result was also evident from an examination of the data obtained on each sex.
- 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, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- No consistent histopathological changes were observed in the tissues or organs of the female test animal at dose level of 200 and 400 mg/kgbw/day.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Description (incidence and severity):
- Altered spermatogenesis are observed in male test group receiving the dose 400 mg/kgbw/day compare to control.
- Reproductive performance:
- not specified
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- histopathology: non-neoplastic
- reproductive function (sperm measures)
- other: No significant effect were observed in histopathology and reproductive fuction
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- 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
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
Observation on male rat
Product dosage |
NO. of rats surviving/ NO. of rats on test |
Sex |
Mean body weight final |
Mean hg |
Mean organ weight mg/g |
Histopathology
|
||||
Testicles |
Altered spermatogenesis |
|||||||||
|
|
|
|
|
||||||
0 mg/kgbw/day |
4/10 |
M |
251.0±11.0 |
17.3±0.40 |
9.7±0.38 |
0 |
||||
200 mg/kgbw/day |
4/10 |
M |
155.0±18.9* |
14.1±0.81* |
9.6±1.32 |
0 |
||||
400mg/kgbw/day |
5/10 |
M |
160±14.0* |
12.8±1.50* |
9.6±1.65 |
3 |
Applicant's summary and conclusion
- Conclusions:
- When the test animal is exposed orally to the test substance 1-(2,4-dimethylphenylazo)-2-naphthol (Sudan II), no adverse effects were observed at a dose level of 200 mg/kg bw/day.
- Executive summary:
The reproductive toxicity study was conducted to evaluate the toxic effects of administration of 1-(2,4-dimethylphenylazo)-2-naphthol (Sudan II) in rats for 20 weeks.
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. Thus, 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. Hence it is not likely to be classiffied as reprotox.
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