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EC number: 607-520-2 | CAS number: 250640-08-5
- 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
Analogue substance EC No. 427-930-3
oral: 28 d, rat, gavage: NOAEL systemic ≥ 1000 mg/kg bw/d (Safepharm Laboratories Ltd. 1235/113, 1999)
Substance itself: No adverse effects were noted in the screening study for reproductive toxicity (OECD 421, GLP) up to the limit dose of 1000 mg/kg bw.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- Adopted 27 July 1995
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): DS-1115A-E-1
- Physical state: red solid
- Analytical purity: 92.6%
- Lot/batch No.: 005
- Storage condition of test material: room temperature in the dark
EC no. 427-930-3 - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Ltd. (UK), Margate, Kent, UK
- Age at study initiation: 5-7 weeks
- Weight at study initiation: males 179-220 g, females 142-197 g
- Housing: groups of 5
- Diet (e.g. ad libitum): Rat and Mouse SQC Expanded Diet No. 1, Special Diet Services Ltd., Witham, Essex, UK, ad lib.
- Water (e.g. ad libitum): water, ad lib.
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2
- Humidity (%): 55 +/- 15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: weekly, storage at 4°C
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
0, 150, 500, 1000 mg/kg bw/d
Basis:
actual ingested - No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on the results of a range-finding study
- Post-exposure recovery period in satellite groups: no - Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: immediately before dosing and 1-5 hrs after dosing (on working days) or 1 hour after dosing (on weekend days)
DETAILED CLINICAL OBSERVATIONS for functional/ bahavioural toxicity: Yes
- Time schedule: on days 6, 13, 20 and 27 (here: including test for sensory sensitivity to different stimuli); approx. two hrs after dosing
- Functional Performance tests include Motor activity observations and tests for Forelimb/ Hindlimb Grip strength
- Sensory reactivity was assessed to auditory, visual and proprioceptive stimuli
BODY WEIGHT: Yes
- Time schedule for examinations: on days 7, 14, 21, 28
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean weekly diet consumption calculated as g food/kg body weight/week: Yes, groupwise
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes, per group
WATER CONSUMPTION: Yes, groupwise
- Time schedule for examinations: daily
HAEMATOLOGY and CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day 28
- Anaesthetic used for blood collection: No
- Animals fasted: No
- How many animals: all
- Parameters checked:
Haematology: Haemoglobin, erythrocyte count, Haematocrit, mean corpuscular haemoglobin, mean corpuscular volume, mean corpuscular concentration, Total leucocyte count, Differential leukocyte count: neutrophils/ lymphocytes, monocytes, eosinophils, basophils, platelet count, methaemoglobin, reticulocyte count, Prothrombin time, Activated partial thromboplastin time
Clinical Chemistry: urea, glucose, total protein, albumin, albumin/globulin ratio, sodium, potassium, chloride, calcium, Inorganic Phosphorus, Creatinine, total cholesterol, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (all animals)
Organ weights: Adrenals, kidneys, testes, brain, liver, thymus, epididymides, ovaries, heart, spleen
HISTOPATHOLOGY: Yes (control and high dose animals plus any macroscopic lesions; liver and spleen from all animals)
Adrenals, aorta, bone & bone marrow (femur incl. stifle joint), brain (incl. cerebrum, cerebellum and pons), caecum, colon, duodenum, epididymis, eyes, gross lesions, heart, ileum, jejunum, kidneys, liver, lungs, lymph nodes, muscle (skeletal), oesophagus, ovaries, pancreas, pituary, prostate, rectum, salivary glands, sciatic nerve, seminal vesicles, skin (hind limb), spinal cord, spleen, stomach, testes, thymus, thyroid/ parathyroid, trachea, urinary bladder and uterus - Statistics:
- One-way ANOVA for haematological and blood chemical parameters, organs weights, body weight gain, functional performance and sensory reactivity data, incorporating Levene´s test for homogeneity of variance. In case of homogenous variance, Dunnett´s tests for pairwise comparisons were done. In case of unequal variances, Kruskal-Wallis ANOVA and/or Mann-Whitney "U" test for non-parametric data were performed.
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Red faeces in all treatment groups and staining of the external body surface in mid and high dose animals were considered as not indicative for toxicity of the test item.
No other clinical signs, no mortality and no effects on functional observations observation.
BODY WEIGHT AND WEIGHT GAIN
No treatment-related effects observed.
Males treated with 500 mg/kg/day showed statistically significant increases in bodyweight gain when compared with controls. An increase in bodyweight gain is unlikely to be associated with test material toxicity and, in any case, a dose response relationship was not evident.
FOOD CONSUMPTION
No effects observed.
WATER CONSUMPTION
No effects observed.
HAEMATOLOGY and CLINICAL CHEMISTRY
No treatment-related effects observed.
Males treated with 1000 mg/kg/day showed a slight but statistically significant increase in neutrophil count when compared with controls There was no histopathological evidence of inflammation and in the absence of a concomitant shift in total or differential leucocyte counts, this minimal (p < 0.05) intergroup difference was considered to have arisen fortuitously.
ORGAN WEIGHTS
No relevant treatment-related effects observed.
Males treated with 1000 mg/kg/day showed slight but statistically significant reductions in epididymis and thymus weight, relative to terminal bodyweight, when compared with controls. Males at the 500 mg/kg/day dose level also showing a reduced relative epididymis weight. There were no macroscopic or microscopic correlates and accordingly these minimal intergroup differences (p<0.05) were considered to be of no toxicological importance.
GROSS PATHOLOGY
No effects observed.
HISTOPATHOLOGY
No effects observed. - Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no relevant effects observed
- Critical effects observed:
- no
- Executive summary:
The read-across approach was used for the ELINCS notification and accepted by the Competent Authority.
Reference
The haematological parameter "basophils" was not statistically analysed since >30% of the data were recorded as the same value.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
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
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No data are available for the substance itself. However, data from a subacute study are available from the strucural analogous substance EC No. 427-930-3. Read-across was applied and approved for by the competant authority as part of the new substance notification which was in place prior to the introduction of the REACH legislation.
A GLP conform subacute toxicity study was performed with according to OECD test guideline 407 (Safepharm Laboratories Ltd. 1235/113, 1999).
The test item was administered by gavage to three groups, each of five male and five female Sprague-Dawley rats, for twenty-eight consecutive days, at dose levels of 150, 500 and 1000 mg/kg bw/day. A control group of five males and five females was dosed with vehicle alone (distilled water).
Clinical signs, functional observations, bodyweight development and food and water consumption were monitored during the study. Haematology and blood chemistry were evaluated for all animals at the end of the study. All animals were subjected to a gross necropsy examination and histopathological evaluation of selected tissues from high dose and control animals was performed.
No treatment-related relevant signs of toxicity were observed.
Therefore, the systemic, subacute "No Observed Adverse Effect Level" (NOAEL) after oral dosing to rats was considered to be
≥ 1000 mg/kg bw/day.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data for the structural analogous substance EC No. 427-930-3 are reliable and suitable for the purpose of classification of Pigment Orange 79 under Regulation (EC) No.1272/2008. Based on the data, classification for repeated dose toxicity is not warranted under Regulation (EC) No.1272/2008.
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