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EC number: 263-417-9 | CAS number: 62121-75-9
- 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
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- Endpoint summary
- Stability
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- 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
A daily oral administration of the test item Reactive Yellow 15 to male
and female Wistar rats at dose levels of 1000 mg (500 mg from study day
38 to 41 onwards for the female animals), 300 mg and 100 mg/kg body
weight over a time period of 41-43 days for males and 54-66 days for
females resulted in some minor animal behavioral changes observed in
male and female animals predominately of the high dose groups,
alterations in water consumption in male (main) and female (recovery)
high dose groups and changes in T4 hormone levels in the high dose
group. Findings for T4 levels could not be seen after a 14-day recovery
period. The findings were not considered adverse. As the findings could
not be associated with a substantial impact on the animal’s health, the
NOAEL regarding the repeated dose toxicity was set to 1000 mg/kg body
weight for the male and female animals when administered for at least 41
days.
All results show that the physicochemical properties of the substance
are responsible for the deaths within the female dose groups.
Toxicological properties, which should have been taken into account for
the determination of the NOAEL, have not been observed in those animals.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral, other
- Remarks:
- subacute toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23. October 2019 to 10. July 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- adopted 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- Wistar rats are commonly used and recommended to assess toxicity. A large number of publications on the subject are available as well as historic data and firsthand experience at the test facility
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Germany
- Females: nulliparous and non-pregnant
- Age at study initiation: 11-12 weeks
- Weight at start of administration: Main: 380 -450 g (males), 205-.246 g (females); Recovery: 357-442 g (males), 212-258 g (females)
HOUSING
- During acclimatization, pre-exposure and pre-mating: male animals as well as female recovery animals were caged in groups of two or three animals per cage (open macrolon cages type 2000P, Techniplast (size slightly larger than GV-SOLAS Type IV)); Individually housed females (main groups), paired animals and single dams with their litters were housed in open macrolon cages Type III; throughout the mating period, animals were kept in pairs of one female and one male rat. The female was placed with the same male until pregnanacy occured ot two weeks have elapsed. After the mating period, male rats were housed in groups of three, which were originally formed during the pre-mating phase; female rats were housed individually.
- Diet (ad libitum): Maintenance diet for rats and mice, No. 1324 TPF; dams: breeding diet for rats and mice, No. 1314 TPF (both: Altromin Spezialfutter GmbH & Co. KG)
- Water (ad libitum): sterilized community tap water
- Acclimation period: 6-9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From 11. November 2019 to 31. January 2020 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Concentration in vehicle:
200 mg/ml (females 100 mg/ml from study day 38-41 onwards)
60 mg/ml
20 mg/ml
Application volume: 5 ml per kg bodyweight - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- In the quantitative re-analysis, the recovered test item content in the test item/water solutions was compared with the target test item content in the preparations. Analysis was conducted by Liquid Chromatography-Diode Array Detector (LC-DAD).
The concentration of the test item in the respective solutions was determined once within pre-mating phase, within the gestation phase and at the end of gestation/ beginning of lactation phase.
Recovery rates between 90-110 % were set as acceptance limits. All criteria were fulfilled. - Duration of treatment / exposure:
- Main groups: Males were dosed daily for 41-43 days (depending on cohort), including the day before the scheduled termination of the in-life phase. Females were dose daily for 53 to 66 days, depending on the female performance during mating and preganancy.
Recovery groups: Male and female animals were dosed daily for 49 days follwed by an observation period of 14 days post treatement. - Frequency of treatment:
- daily
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- high dose; for females reduced to 500 mg/kg bw/day from study day 38-41 onwards
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Remarks:
- medium dose
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- low dose
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- vehicle
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- Recovery high dose; for femlaes reduced to 500 mg/kg bw/day from study day 38-41 onwards
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Recovery, vehicle
- No. of animals per sex per dose:
- 12/sex/dose (reproductive toxicity)
--> thereof 5/sex/dose for the repeated dose toxicity evaluation (randomly selected)
5/sex/dose (recovery groups) - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Dose selection rationale: According to the available literature, no toxic effects of the test item has been observed at a dose of 500 mg/kg bw during a 20-day oral administration with a total of 14 administrations . In addition, the LD50 value (oral) in mice was reported to be >10.000 mg/kg bw, the LD50 for rats is specified as greater 2000 mg/kg bw. Based on this information, the Sponsor decided to test 1000 mg/kg bodyweight per day as the highest dose. An interval of approximately 3 has been chosen for the two subsequent doses resulting in 300 mg/kg bw/day for the medium dose and 100 mg/kg bw/day for the low dose group.
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly (IRWIN test) in a standard arena, on all animals (Main and recovery groups)
BODY WEIGHT: Yes
- Time schedule for examinations: At least once weekly (inlcuding once before beginning of application)
FOOD CONSUMPTION: Yes
- Time schedule for examinations: At least once weekly
WATER CONSUMPTION: Yes
- Time schedule for examinations: At least once weekly
HAEMATOLOGY: Yes
On randomly selected male and female animals per dose group (main groups):
- 5 females at the end of the pre-mating period
- 5 males at the end of the treatement period.
- on all recovery animals at the end of the recovery period
- Anaesthetic used for blood collection: Yes (Isoflurane)
- Animals fasted: No
- Parameters examined: Leukocytes, Erythrocytes, Haemoglobin, Haematocrit, Mean corpuscular volume (MCV), Mean corpuscular Haemoglobin (MCH), Mean corpuscular haemoglobin conc. (MCHC), Thrombocytes, Reticulocytes, Neutrophil granulocytes, Lymmphocytes, Monocytes, Eosinophils, Basophils, Blood clotting
time.
- How many animals: 5 per sex and dose group
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: On randomly selected male and female animals per dose group (main groups):
- 5 females at the end of the pre-mating period
- 5 males at the end of the treatement period.
- on all recovery animals at the end of the recovery period
- Anaesthetic used for blood collection: Yes (Isoflurane)
- Animals fasted: No
- Parameters examined: Alkaline Phosphatase (AP), Aspartate
aminotransferase (AST); Alanine aminotransferase (ALT),
Gamma-glutamyl-transferase (GGT), Cholesterol, Urea, Sodium, Potassium, Calcium, Chloride, Glucose, Total protein, Albumin, Globulin, A/G ratio, Creatinine, Bile acids, T4-hormone levels
- How many animals: 5 per sex and dose group
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: at the end of the in-life phase
- Dose groups that were examined: all
- Battery of functions tested: sgrip strength and beam-walking test - Sacrifice and pathology:
- All adult animals were sacrificed humanely by asphyxiation in a CO2/O2 atmosphere and were examined macroscopically. All occurring lesions were recorded on checklists for each individual animal. Special attention was paid to the organs of the reproductive system. The number of implantation
sides was recorded. Organs were surgically extracted from adult male animals (testes, epididymis, prostate and seminal gland vesicles with coagulating gland as a whole, LABC muscle, Cowper’s gland,
glans penis) and from all adult female animals (uterus including cervix, ovaries) and were weighed as soon as possible after dissection. The thyroid glands were surgically extracted from both, male and female animals and weighed before fixation. Paired organs were weighed individually. The ovaries, testes, epididymis, accessory sex organs (cervix, prostate etc.), thyroid and all other organs showing macroscopic lesions of all adult animals were preserved in the appropriate fixative.
From all recovery animals and 5 randomly selected male and female animals per dose group (main groups), additional organs were preserved in the appropriate fixative/s (adrenal glands, bone marrow (sternum), brain, esophagus, eyes, heart, large and small intestine, kidneys, liver, lung, lymph nodes (axillary and mesenterial), mammary glands, sceletal muscle, peripheral nerve, pituitary gland, spinal cord, spleen, stomach, thymus, trachea, urinary bladder, vagina). Organs to be weighed were trimmed of any adherent tissue and their wet weight was taken as soon as possible after dissection. Paired organs were weighed individually.
Modified Davidson solution was used for testis and epididymis; Davidson solution was used for the eyes. All other organs/tissues were fixed in formalin.
ADDITIONAL ORGAN WEIGHTS
for 5 male and female animals per dose group:
brain, heart, liver, spleen, thymus, kideny, adrenal glands
HISTOPATHOLOGY (selected animals)
A detailed histological examination was performed on selected organs and tissues of the animals of the main high dose and the vehicle control group. The thyroid glands of the remaining animals were included in the histology panel, due to test item-related findings from the T4-analysis.
The tissues were embedded in paraffin wax, sectioned, and stained with hemalum and eosin. - Statistics:
- Anova with Dunnett's t-test
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Salivation after test item administration as well as wiping the mouth in the cage bedding was observed for individual male animals of the high dose groups (main and recovery). Signs of salivation were considered related to the lack of palatability of the administered test item and were rated as neglectable or mild under consideration of intensity and frequency of incidence, and with no adversity associated.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Five female animals treated with the high dose of the test item (four of the main groups, one of the recovery group) and one animal of the medium dose group died soon after gavage, showing signs of reflux. The test item solutions showed viscous, not yet described physical characteristics. A gavage related reflux was assumed as most likely cause of death for those animals. A physicochemical relationship is therefore assumed rather than a toxicological property of the substance.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Male main group animals of the high dose as well as female animals of the recovery groups showed test-item related increase in water consumption during treatment period, when compared to the respective vehicle control group, but below amounts considered to be adverse. A secondary effect related to the increase in salivation and/or the high concentration of the formulation might be conceivable.
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Endocrine findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- T4-analysis of parental animals revealed significant increase of the T4 hormone level in the high dose groups (male and female) and the medium dose animals (males only) when compared to the respective vehicle control group. The values for the pups (day 4pp and day 13 pp) showed no difference between test item treated animals and controls. After 14 days recovery, no significant changes for the T4 hormone levels have been observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Critical effects observed:
- no
- Conclusions:
- The NOAEL regarding the repeated dose toxicity was set to >= 1000 mg/kg body weight for the male and female animals when administered for at least 41 days.
- Executive summary:
A daily oral administration of the test item Reactive Yellow 15 to male and female Wistar rats at dose levels of 1000 mg (500 mg from study day 38 to 41 onwards for the female animals), 300 mg and 100 mg/kg body weight over a time period of 41-43 days for males and 54-66 days for females resulted in some minor animal behavioral changes observed in male and female animals predominately of the high dose groups, alterations in water consumption in male (main) and female (recovery) high dose groups and changes in T4 hormone levels in the high dose group. Findings for T4 levels could not be seen after a 14-day recovery period. The findings were not considered adverse. As the findings could not be associated with a substantial impact on the animal’s health, the NOAEL regarding the repeated dose toxicity was set to 1000 mg/kg body weight for the male and female animals when administered for at least 41 days.
All results show that the physicochemical properties of the substance are responsible for the deaths within the female dose groups. Toxicological properties, which should have been taken into account for the determination of the NOAEL, have not been observed in those animals.
Furthermore, no pathological evidence for toxic effects on the reproduction performance of female and male rats was found. Regarding the overall time period of gestation/lactation and after birth until end of in-life phase no evidence for a toxic effect on the pup development could be detected. The NOAEL regarding reproduction and development of Reactive Yellow 15 under these study conditions was set to be >= 1000 mg/kg body weight for the female and male animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- 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
In the present study, toxic effectsof the test item Reactive Yellow 15 on male and female rats after repeated dosing, as well as any possible effects on the development and reproduction of Wistar rats combined with assessment of potential sub-acute toxicity after oral administration and recovery from any treatment-related effects during a period of 2 weeks were under examination.
The test item was administered daily by oral gavage to 12 male and female adult rats in three groups at dosages of 1000 mg (500 mg from study day 38-41 [depending on cohort] onwards for the female animals), 300 mg and 100 mg test item per kg body weight over a period of 41 to 43 days (males) and 53 to 66 days (females). Male and female animals were mated within their treatment group during the treatment period. Litters were used for evaluation of developmental and reproduction related parameters but did not receive test item treatment. Further 24 animals (12 males and 12 females) received the vehicle solution as control; all other parameters were identical.
A further group of 10 animals (5 male / 5 female) was treated daily at a dosage of 1000 mg/kg test item (500 mg/kg from study day 38-41 [depending on cohort] onwards for the female animals) over a period of 49 days. For evaluation of reversibility, persistence, or delayed occurrence of toxic effects, these animals were observed for 14 days post treatment. Further 10 animals (5 males and 5 females) received the vehicle solution as control; all other parameters were identical. A mating process for these animals was not included.
Clinical signs, viability, reactions to treatment and conspicuous behavioral traits of all experimental groups were monitored daily during the in-life phase. The oestrus cycle of female animals was monitored daily two weeks prior test item dosing, during test item dosing until evidence of mating and on day of necropsy. Individual body weight was recorded once weekly. Individual food / water consumption of female animals and group food / water consumption of male animals were recorded once weekly. Detailed clinical signs were monitored weekly from all adult animals. Grip-strength and beam-walking test were assessed from 5 randomly selected adult animals per sex and dose group during the last exposure week.
Offspring parameters were assessed from each litter on day 0 post-partum (pp), day 4pp, day 13pp and day of necropsy as specified by the study plan. Blood samples from selected offspring per litter were taken on day 4pp to provide T4-hormone data.
At the end of the treatment period (dams and pups between 16-18 days post-partum; males after 41-43 days of treatment, depending on cohort), blood samples were taken from all adult animals and selected offspring per litter to provide T4-hormone data. For assessment of additional toxicological parameters, 5 adult animals per sex and group were randomly selected for additional blood sampling (females during end of pre-mating, males at day of necropsy) to provide data on hematology and clinical biochemistry.
All adult and offspring animals were sacrificed at the end of the treatment or recovery period and examined by gross necropsy. According to the study plan, weights of selected organs were recorded, and selected tissues and organs were preserved with special emphasis on organs of the reproductive system. From 5 randomly selected adult animals per sex and dose group, additional organs were preserved, as specified by the study plan. In order to be able to correlate possible toxicological findings, the 5 randomly selected male and female animals were the same for all parameters (hematology, clinical biochemistry, full histopathological examination, functional observations (grip-strength and beam-walk)).
Salivation after test item administration was observed for individual male animals of the high dose groups (main and recovery). This was observed occasionally until the end of test item administration, but only in individual cases. Salivation was not observed during recovery phase. Signs of salivation were considered related to the lack of palatability of the administered test item and were rated as neglectable or mild under consideration of intensity and frequency of incidence, and with no adversity associated.
Within the scope of the IRWIN test, no abnormal clinical signs or test item related changes in animal behavior were detected over the course of the study. Also, the grip-strength and beam-walking tests returned no abnormal findings.
Five female animals treated with the high dose of the test item (four of the main groups, one of the recovery group) and one female animal treated with the medium dose died soon after gavage. Signs of reflux (test item in trachea and lung) were observed during necropsy. The test item solutions showed viscous, not yet described physical characteristics. A gavage related reflux was assumed as most likely cause of death for those animals. A physicochemical relationship is therefore assumed rather than a toxicological property of the substance.
Regarding the body weight and the body weight gain, no significant differences were observed between all test item-treated animal groups (male and female) and the respective vehicle control groups. Occasional differences observed for the female animals at specific time intervals of the in-life phase could be correlated with the animal’s pregnancy and lactation status and were therefore strongly considered to be of natural origin.
The monitoring of food consumption revealed no test item-related difference between all female and male experimental dose groups and the respective vehicle control groups. The observed variations showed no dose-dependency and were within limits frequently observed for animals of this sex and age and could therefore not be associated with a test item-related adverse effect.
Male main group animals of the high dose as well as female animals of the recovery groups showed test-item related differences in water consumption during treatment period, when compared to the respective vehicle control group, but below amounts considered to be adverse. A secondary effect related to the increase in salivation and/or the high concentration of the formulation might be conceivable.
Somedifferences generally observed in female food and water consumption between late pregnancy/ lactation phases and the early gestation phase were related to the specific physiological condition of the animalsand therefore considered not adverse or toxicological relevant.
T4-anaylsis of parental animals revealed significant increase of the T4 hormone level in the high dose groups (male and female) and the medium dose animals (males only) when compared to the respective vehicle control group. The values for the pups (day 4 pp and day 13 pp) showed no difference between test item treated animals and controls. After 14 daysrecovery, no significant changes for the T4 hormone levels have been observed.
No toxicological effects of the test item were observed in hematology and clinical biochemistry of selected animals from all test item-treated groups. Few conspicuous values of hematology and clinical chemistry in the recovery groupswere evaluated as statistical artifacts without toxicological relevance.
The necropsy of sires, dams and older pups (day 15-19pp) did not reveal any findings, which could be regarded as adverse or toxicological relevant for animal reproduction or development. None of the findings could be associated with the administration of the test item.
The microscopic analysis of the female and male reproductive organs did not show any test item-related lesions in any animal of the high dose groups. The microscopic analysis of the other submitted organs of the high doe animals did also not identify any test item-related lesions. The microscopic analysis of the thyroid glands of all experimental animals identified no lesions related to the dosing with the test item.
Regarding reproduction and development (achievement and duration of pregnancy, offspring losses, survival rate of pups and development of pups) no difference was observed for all test item treated-animals, when compared to the vehicle control animals. There was no evidence for any test item related effect.
In conclusion, adaily oral administration of the test item Reactive Yellow 15 to male and female Wistar rats at dose levels of1000 mg (500 mg from study day 38 to 41 onwards for the female animals), 300 mg and 100 mg/kg body weight over a time period of 41-43 days for males and 54-66 days for females resulted in some minor animal behavioral changes observed in male and female animals predominately of the high dose groups, alterations in water consumption in male (main) and female (recovery) high dose groups and changes in T4 hormone levels in the high dose group. Findings for T4 levels could not be seen after a 14-day recovery period. The findings were not considered adverse. As the findings could not be associated with a substantial impact on the animal’s health, the NOAEL regarding the repeated dose toxicity was set to 1000 mg/kg body weight for the male and female animals when administered for 41 days.
All results show that the physicochemical properties of the substance are responsible for the deaths within the female dose groups. Toxicological properties, which should have been taken into account for the determination of the NOAEL, have not been observed in those animals.
Furthermore, no pathological evidence for toxic effects on the reproduction performance of female and male rats was found. Regarding the overall time period of gestation/lactation and after birth until end of in-life phase no evidence for a toxic effect on the pup development could be detected. The NOAEL regarding reproduction and development of Reactive Yellow 15 under these study conditions was set to be 1000 mg/kg body weight for the female and male animals.
Justification for classification or non-classification
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