Registration Dossier
Registration Dossier
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EC number: 274-352-0 | CAS number: 70161-16-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Experimental data of read across substances
- Justification for type of information:
- Data for the target chemical is summarized based on the structurally similar read across chemicals
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- three-generation reproductive 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- The reproductive effects of test material on male and female Charles River CD rats by oral (Diet) route at different dose levels was examined.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
- Specific details on test material used for the study:
- No data available
- Species:
- rat
- Strain:
- other: Charles River CD
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source:No data available- Females (if applicable) nulliparous and non-pregnant: [yes/no]- Age at study initiation: (P) x wks; (F1) x wksNo data available- Weight at study initiation: (P) Males: x-x g; Females: x-x g; (F1) Males: x-x g; Females: x-x gNo data available- Fasting period before study:No data available- Housing:Animals were housed individually - Use of restrainers for preventing ingestion (if dermal): yes/no- Diet (e.g. ad libitum):the test diet ad libitum- Water (e.g. ad libitum):No data available- Acclimation period:No data availableENVIRONMENTAL CONDITIONS- Temperature (°C):No data available- Humidity (%):No data available- Air changes (per hr):No data available- Photoperiod (hrs dark / hrs light):IN-LIFE DATES: From: To:No data available
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: test material mixed with food
- Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Pre-Mating Exposure / Males and Females: 60 days and test material adminstered upto three generation
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
- Remarks:
- Doses / Concentrations:5, 50, 150 or 500 mg/kg bw/dayBasis:
- No. of animals per sex per dose:
- Total :1500mg/kg bw/day : 10 males and 20 females5 mg/kg bw/day : 10 males and 20 females50 mg/kg bw/day :10 males and 20 females150 mg/kg bw/day :10 males and 20 females 500 mg/kg bw/day : 10 males and 20 females
- Control animals:
- yes
- Details on study design:
- No data available
- Positive control:
- No data available
- Parental animals: Observations and examinations:
- Parental animals observation and examinationsCAGE SIDE OBSERVATIONS: yes Clinical observations were recorded twice daily with at least 5 hours between observationsDETAILED CLINICAL OBSERVATIONS: Yes Time schedule: Detailed physical examinations and palpation for masses were performed weekly.BODY WEIGHT: YesTime schedule for examinations: weekly for the first fourteen weeks, bi-weekly for the next 12 weeks and every 4 weeks thereafter until the end of the study. FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes weekly for the first fourteen weeks, bi-weekly for the next 12 weeks and every 4 weeks thereafter until the end of the study.. 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: Yes , WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data Time schedule for examinations: OTHER: Haematology tests, including hemoglobin, hematocrit, erythrocyte and total and differential leukocyte counts, and erythrocyte morphology, were conducted on ten randomly selected animals at months 3, 6, 12, 18 and 24 of the study.
- Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- 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.] - Maternal animals: All surviving animals [describe when, e.g. after the last litter of each generation was weaned.] GROSS NECROPSYNecropsies were conducted on all animals dying prior to study termination, killed in a moribund condition or killed on schedule,Tissues examined included adrenal glands, aorta, blood smear, brain, cecum, colon, duodenum, epididymus or uterus, esophagus, eyes, femur including marrow, tissue masses, gallbladder, heart, ileum, jejunum, duodenum, kidneys, liver, lungs and bronchi, mammary gland, nerves (sciatic), ovaries, lymph nodes, pancreas, parathyroids, pituitary gland, prostrate, rectum, skin, spleen, seminal vesicles, skeletal muscle, testes with ep ididymides, stomach, thymus, thyroid gland including parathyroid, trachea, urinary bladder, uterus HISTOPATHOLOGY / ORGAN WEIGHTSHistological examinations were conducted on all animals from both control groups, the highest dose group (2.0 or 5.0%) from each study and also on 10 rats randomly selected from each group for an interim sacrifice at 12 months. Histology was also performed on any animal with gross lesions or masses
- Postmortem examinations (offspring):
- No data available
- Statistics:
- No data available
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No treatment-related effects were reported on survival
- 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:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were reported on haematological finding
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were reported on clinical chemistry
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were reported on urinalysis.
- Behaviour (functional findings):
- not specified
- 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 compound related lesions in any tissue examined histologically, including kidneys and adrenal glands from parental rats.
- Histopathological findings: neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Histological evaluation revealed a variety of lesions, including neoplasms, present at similar incidences in control and treated animals.The authors considered the lesions to be spontaneous and not related to administration of the test material.
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- There were no compound related effects on fertility, gestation, pup viability or lactation indices, on reproductive organs of females, or on organ weights among parents.
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- haematology
- clinical biochemistry
- urinalysis
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- histopathology: neoplastic
- reproductive performance
- other: see 'Remark'
- Remarks on result:
- other: No effects on reproductive performance was observed
- 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
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- no compound related effects on pup viability or lactation indices.
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food consumption was similar for control and treated animals at the lower dietary levels, but was slightly higher in the 500 mg/kg bw dose group although not statistically significant.
- 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 treatment-related effects were reported on Haematological finding
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were reported on clinical chemistry
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- no compound related effects on organ weights
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Necropsies did not reveal any treatment-related gross or microscopic changes.
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- There were no compound related lesions in any tissue examined histologically, including kidneys and adrenal glands from offspring.
- Other effects:
- no effects observed
- Description (incidence and severity):
- There were no compound related effects on fertility, gestation, pup viability or lactation indices, on reproductive organs of females, or on organ weights among offspring.
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- mortality
- food consumption and compound intake
- haematology
- clinical biochemistry
- urinalysis
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- Remarks on result:
- other: Overall no developmental toxic effects were observed
- 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
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food consumption was similar for control and treated animals at the lower dietary levels, but was slightly higher in the 500 mg/kg bw dose group although not statistically significant.
- 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 treatment-related effects were reported on Haematological finding
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were reported on clinical chemistry
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were reported on urinalysis
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- no compound related effects on organ weights
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Necropsies did not reveal any treatment-related gross or microscopic changes.
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- There were no compound related lesions in any tissue examined histologically, including kidneys and adrenal glands from offspring.
- Other effects:
- no effects observed
- Description (incidence and severity):
- There were no compound related effects on fertility, gestation, pup viability or lactation indices, on reproductive organs of females, or on organ weights among offspring.
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- mortality
- food consumption and compound intake
- haematology
- clinical biochemistry
- urinalysis
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- Remarks on result:
- other: overall no developmental effects were observed
- 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
- 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
- Conclusions:
- NOAEL was considred to be 500mg/kg bw/day for F0, F1 and F2 generation. When male and female Charles River CD rats were treated with test material orally.
- Executive summary:
Three generation reproductive study of test material was performed on male and female Charles River CD rats. Animals were housed individually and fed the test diet ad libitum. The test material mixed with food in dose concentration 0, 5, 50, 150 or 500 mg/kg bw/day and 10 males and 20 females/group/generation were used .Pre-Mating Exposure / Males and Females were 60 days. Clinical observations were recorded twice daily with at least 5 hours between observations. Detailed physical examinations and palpation for masses were performed weekly. Body weights and food consumption were determined weekly for the first fourteen weeks, bi-weekly for the next 12 weeks and every 4 weeks thereafter until the end of the study. The intake of the test substance was determined from body weight, food consumption and dietary concentration. Haematology tests, including haemoglobin, haematocrit, erythrocyte and total and differential leukocyte counts, and erythrocyte morphology, were conducted on ten randomly selected animals at months 3, 6, 12, 18 and 24 of the study. Necropsies were conducted on all animals dying prior to study termination, killed in a moribund condition or killed on schedule. Histological examinations were conducted on all animals from both control groups, the highest dose group (2.0 or 5.0%) from each study and also on 10 rats randomly selected from each group for an interim sacrifice at 12 months. Histology was also performed on any animal with gross lesions or masses. Also tissues examined included adrenal glands, aorta, blood smear, brain, cecum, colon, duodenum, epididymus or uterus, esophagus, eyes, femur including marrow, tissue masses, gallbladder, heart, ileum, jejunum, duodenum, kidneys, liver, lungs and bronchi, mammary gland, nerves (sciatic), ovaries, lymph nodes, pancreas, parathyroids, pituitary gland, prostrate, rectum, skin, spleen, seminal vesicles, skeletal muscle, testes with epididymides, stomach, thymus, thyroid gland including parathyroid, trachea, urinary bladder, uterus.
At the end of study, no treatment-related effects were reported on survival. No treatment-related changes were reported at gross necropsy. Histological evaluation revealed a variety of lesions, including neoplasms, present at similar incidences in control and treated animals. The authors considered the lesions to be spontaneous and not related to administration of the test material. There were no compound related effects on fertility, gestation, pup viability or lactation indices, on reproductive organs of females, or on organ weights among parents and offspring. There were no compound related lesions in any tissue examined histologically, including kidneys and adrenal glands from parental rats or from offspring. There was no toxicity to either the F1 or F2 generation. Food consumption was similar for control and treated animals at the lower dietary levels, but was slightly higher in the high-dose study, although not statistically significant. Haematological, clinical chemistry and urinalysis parameters did not differ significantly from the controls. Necropsies at one year did not reveal any treatment-related gross or microscopic changes. Hence NOAEL was considered to be 500mg/kg bw/day for F0, F1 and F2 generation. When male and female Charles River CD rats were treated with test material orally.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- multi-generation reproductive 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Multigeneration toxicity study of test material was performed on male and female wistar rats.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
- Specific details on test material used for the study:
- No data available
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on exposure:
- No data available
- Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- From F1 to F3 generation
- Frequency of treatment:
- No data available
- Details on study schedule:
- No data available
- Remarks:
- 0, 0.1, 1.0 or 3% (0, 50, 500,1500 mg/kg bw per day)
- No. of animals per sex per dose:
- Total:3600 mg/kg bw: 60 male and 60 female 50 mg/kg bw : 40male and 40 female 500 mg/kg bw : 40male and 40 female 1500 mg/kg bw : 40male and 40 female After a nine-week test period, 24 males and 24 females from the control group, and 14 males and 14 females from each test group were used for teratogenicity studies; the remainder were used for the reproduction study.
- Control animals:
- yes
- Details on study design:
- No data available
- Positive control:
- No data available
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: yes - Time schedule: - Cage side observations checked in table [No.?] were included. DETAILED CLINICAL OBSERVATIONS: Yes / No / No data - Time schedule: BODY WEIGHT: Yes - Time schedule for examinations: FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): - 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: OTHER:
- Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- STANDARDISATION OF LITTERS- Performed on day 4 postpartum: [yes/no]- If yes, maximum of [...] pups/litter ([...]/sex/litter as nearly as possible); excess pups were killed and discarded. PARAMETERS EXAMINEDThe following parameters were examined in [F1 / F2 / F3] offspring:number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, were observed GROSS EXAMINATION OF DEAD PUPS:yes ASSESSMENT OF DEVELOPMENTAL NEUROTOXICITY:ASSESSMENT OF DEVELOPMENTAL IMMUNOTOXICITY:
- Postmortem examinations (parental animals):
- Postmortem examinations (Parent Animal)SACRIFICEYes, Autopsy did of parent ratsGROSS NECROPSY:No data availableHISTOPATHOLOGY / ORGAN WEIGHTS: No data available
- Postmortem examinations (offspring):
- Postmortem examinations (offspring)SACRIFICEF1,F2, F3 pups were sacrificed.GROSS NECROPSYYesHISTOPATHOLOGY / ORGAN WEIGTHSYes
- Statistics:
- No data available
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- 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
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects on reproductive function was observed
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- reproductive performance
- Remarks on result:
- other: No effects on fertility was observed
- 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
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- sexual maturation
- mortality
- body weight and weight gain
- organ weights and organ / body weight ratios
- Remarks on result:
- other: No effects on reproductive parameters observed
- 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
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- sexual maturation
- clinical signs
- mortality
- organ weights and organ / body weight ratios
- Remarks on result:
- other: No effects on reproductive parameters was observed
- 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
- 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
- Conclusions:
- NOAEL was considered to be at 3% (1500 mg/kg bw per day) for F0, F1 and F2 generation .When male and female wistar rats were treated with test material orally.
- Executive summary:
A multigeneration reproductive toxicity study of test material was performed on male and female wistar rats. The test material mixed with feed in dose concentration 0, 0.1, 1.0 or 3% (0, 50, 500, 1500 mg/kg bw per day) and administered orally for three successive generations. Each generation having 60 animals of each sex in the control and 40 animals of each sex in test animals. No adverse effects were observed with respect to fertility, litter size and weight, general condition, male/female ratio, growth during lactation, survival or maturation. Autopsy of parent rats and pups at weaning did not reveal any treatment related changes in organ weights other than caecal enlargement in the 3% dose group. Gross and microscopic examination of the F3 generation at weaning did not reveal any abnormalities due to treatment and no adverse effects were seen in the teratology study. It was concluded that Brilliant Black PN did not exert any adverse effects on reproductive function of Wistar rats when fed at dietary levels up to 3% (1500 mg/kg bw per day) for three successive generations. Therefore, NOAEL was considered to be at 3% (1500 mg/kg bw per day) for F0 F1 and F2 generation .When male and female wistar rats were treated with test material orally.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- WoE report is based on two reproductive toxicity studies on rats1.The reproductive effects of test material on male and female Charles River CD rats by oral (Diet) route at different dose levels was examined. 2.Multigeneration toxicity study of test material was performed on male and female wistar rats.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- Tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate
- EC Number:
- 274-352-0
- EC Name:
- Tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate
- Cas Number:
- 70161-16-9
- Molecular formula:
- C29H20ClN9O12S4.4Na
- IUPAC Name:
- tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (IUPAC name): tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate- Molecular formula: C29H20ClN9O12S4.4Na- Molecular weight:938.173 g/mol- Smiles notation: [Na+].[Na+].[Na+].[Na+].c1(c(cc(cc1)S(=O)(=O)[O-])\N=N\c1ccc(c2ccc(cc12)S(=O)(=O)[O-])\N=N\c1ccc(c2c(cccc12)S(=O)(=O)[O-])Nc1nc(nc(n1)N)Cl)S(=O)(=O)[O-]- InChl: 1S/C29H20ClN9O12S4.4Na/c30-27-33-28(31)35-29(34-27)32-22-10-9-20(17-2-1-3-25(26(17)22)55(49,50)51)37-36-19-7-8-21(18-12-14(52(40,41)42)4-6-16(18)19)38-39-23-13-15(53(43,44)45)5-11-24(23)54(46,47)48;;;;/h1-13H,(H,40,41,42)(H,43,44,45)(H,46,47,48)(H,49,50,51)(H3,31,32,33,34,35);;;;/q;4*+1/p-4/b37-36+,39-38+;;;;- Substance type: Organic- Physical State: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: 1.Charles River CD 2.Wistar
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 1. TEST ANIMALS- Source:No data available- Females (if applicable) nulliparous and non-pregnant: [yes/no]- Age at study initiation: (P) x wks; (F1) x wksNo data available- Weight at study initiation: (P) Males: x-x g; Females: x-x g; (F1) Males: x-x g; Females: x-x gNo data available- Fasting period before study:No data available- Housing:Animals were housed individually - Use of restrainers for preventing ingestion (if dermal): yes/no- Diet (e.g. ad libitum):the test diet ad libitum- Water (e.g. ad libitum):No data available- Acclimation period:No data availableENVIRONMENTAL CONDITIONS- Temperature (°C):No data available- Humidity (%):No data available- Air changes (per hr):No data available- Photoperiod (hrs dark / hrs light):IN-LIFE DATES: From: To:No data available
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: test material mixed with food
- Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 1. Pre-Mating Exposure / Males and Females: 60 days and test material adminstered upto three generation 2.From F1 to F3 generation
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:Study 1.5, 50, 150 or 500 mg/kg bw/dayStudy 2.0, 0.1, 1.0 or 3% (0, 50, 500,1500 mg/kg bw per day)Basis:
- No. of animals per sex per dose:
- Study1.Total :1500mg/kg bw/day : 10 males and 20 females5 mg/kg bw/day : 10 males and 20 females50 mg/kg bw/day :10 males and 20 females150 mg/kg bw/day :10 males and 20 females 500 mg/kg bw/day : 10 males and 20 femalesStudy2.Total:3600 mg/kg bw: 60 male and 60 female 50 mg/kg bw : 40male and 40 female 500 mg/kg bw : 40male and 40 female 1500 mg/kg bw : 40male and 40 female After a nine-week test period, 24 males and 24 females from the control group, and 14 males and 14 females from each test group were used for teratogenicity studies; the remainder were used for the reproduction study.
- Control animals:
- yes
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Study1.Parental animals observation and examinationsCAGE SIDE OBSERVATIONS: yes Clinical observations were recorded twice daily with at least 5 hours between observationsDETAILED CLINICAL OBSERVATIONS: Yes Time schedule: Detailed physical examinations and palpation for masses were performed weekly.BODY WEIGHT: YesTime schedule for examinations: weekly for the first fourteen weeks, bi-weekly for the next 12 weeks and every 4 weeks thereafter until the end of the study. FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes weekly for the first fourteen weeks, bi-weekly for the next 12 weeks and every 4 weeks thereafter until the end of the study.. 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: Yes , WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data Time schedule for examinations: OTHER: Haematology tests, including hemoglobin, hematocrit, erythrocyte and total and differential leukocyte counts, and erythrocyte morphology, were conducted on ten randomly selected animals at months 3, 6, 12, 18 and 24 of the study.Study2.CAGE SIDE OBSERVATIONS: yes - Time schedule: - Cage side observations checked in table [No.?] were included. DETAILED CLINICAL OBSERVATIONS: Yes / No / No data - Time schedule: BODY WEIGHT: Yes - Time schedule for examinations: FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): - 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: OTHER:
- Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- 2.STANDARDISATION OF LITTERS- Performed on day 4 postpartum: [yes/no]- If yes, maximum of [...] pups/litter ([...]/sex/litter as nearly as possible); excess pups were killed and discarded. PARAMETERS EXAMINEDThe following parameters were examined in [F1 / F2 / F3] offspring:number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, were observed GROSS EXAMINATION OF DEAD PUPS:yes ASSESSMENT OF DEVELOPMENTAL NEUROTOXICITY:ASSESSMENT OF DEVELOPMENTAL IMMUNOTOXICITY:
- Postmortem examinations (parental animals):
- 1.SACRIFICE - Male animals: All surviving animals [describe when, e.g. as soon as possible after the last litters in each generation were produced.] - Maternal animals: All surviving animals [describe when, e.g. after the last litter of each generation was weaned.] GROSS NECROPSYNecropsies were conducted on all animals dying prior to study termination, killed in a moribund condition or killed on schedule,Tissues examined included adrenal glands, aorta, blood smear, brain, cecum, colon, duodenum, epididymus or uterus, esophagus, eyes, femur including marrow, tissue masses, gallbladder, heart, ileum, jejunum, duodenum, kidneys, liver, lungs and bronchi, mammary gland, nerves (sciatic), ovaries, lymph nodes, pancreas, parathyroids, pituitary gland, prostrate, rectum, skin, spleen, seminal vesicles, skeletal muscle, testes with ep ididymides, stomach, thymus, thyroid gland including parathyroid, trachea, urinary bladder, uterus HISTOPATHOLOGY / ORGAN WEIGHTSHistological examinations were conducted on all animals from both control groups, the highest dose group (2.0 or 5.0%) from each study and also on 10 rats randomly selected from each group for an interim sacrifice at 12 months. Histology was also performed on any animal with gross lesions or massesStudy 2.Postmortem examinations (Parent Animal)SACRIFICEYes, Autopsy did of parent ratsGROSS NECROPSY:No data availableHISTOPATHOLOGY / ORGAN WEIGHTS: No data available
- Postmortem examinations (offspring):
- 2.Postmortem examinations (offspring)SACRIFICEF1,F2, F3 pups were sacrificed.GROSS NECROPSYYesHISTOPATHOLOGY / ORGAN WEIGTHSYes
- Statistics:
- No data available
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- 1.No treatment-related effects were reported on survival
- 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:
- no effects observed
- Description (incidence and severity):
- 1.No treatment-related effects were reported on haematological finding
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- 1.No treatment-related effects were reported on clinical chemistry
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- 1.No treatment-related effects were reported on urinalysis.
- Behaviour (functional findings):
- not specified
- 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):
- 1.no compound related lesions in any tissue examined histologically, including kidneys and adrenal glands from parental rats.
- Histopathological findings: neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 1.Histological evaluation revealed a variety of lesions, including neoplasms, present at similar incidences in control and treated animals.The authors considered the lesions to be spontaneous and not related to administration of the test material.
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- 1.There were no compound related effects on fertility, gestation, pup viability or lactation indices, on reproductive organs of females, or on organ weights among parents.2.No treatment-related effects on reproductive function was observed
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- > 500 - < 1 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- haematology
- clinical biochemistry
- urinalysis
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- histopathology: neoplastic
- reproductive performance
- other: see 'Remark'
- Remarks on result:
- other: No effects on reproductive performance was 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:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- 1&2 .no compound related effects on pup viability or lactation indices.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- 2.No effects on body weight was observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- 1.Food consumption was similar for control and treated animals at the lower dietary levels, but was slightly higher in the 500 mg/kg bw dose group although not statistically significant.
- 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):
- 2.No treatment-related effects were reported on Haematological finding
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- 1.No treatment-related effects were reported on clinical chemistry
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- 1&2.no compound related effects on organ weights
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- 1.Necropsies did not reveal any treatment-related gross or microscopic changes.
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- 1.There were no compound related lesions in any tissue examined histologically, including kidneys and adrenal glands from offspring.
- Other effects:
- no effects observed
- Description (incidence and severity):
- 1.There were no compound related effects on fertility, gestation, pup viability or lactation indices, on reproductive organs of females, or on organ weights among offspring.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 500 - < 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- mortality
- food consumption and compound intake
- haematology
- clinical biochemistry
- urinalysis
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- Remarks on result:
- other: Overall no developmental toxic effects were observed
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
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- 1.Food consumption was similar for control and treated animals at the lower dietary levels, but was slightly higher in the 500 mg/kg bw dose group although not statistically significant.
- 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):
- 1.No treatment-related effects were reported on Haematological finding
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- 1.No treatment-related effects were reported on clinical chemistry
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- 1.No treatment-related effects were reported on urinalysis
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- 1&2.no compound related effects on organ weights
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- 1.Necropsies did not reveal any treatment-related gross or microscopic changes.
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- 1.There were no compound related lesions in any tissue examined histologically, including kidneys and adrenal glands from offspring.
- Other effects:
- no effects observed
- Description (incidence and severity):
- 1.There were no compound related effects on fertility, gestation, pup viability or lactation indices, on reproductive organs of females, or on organ weights among offspring.
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- > 500 - < 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- mortality
- food consumption and compound intake
- haematology
- clinical biochemistry
- urinalysis
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- Remarks on result:
- other: overall no developmental effects were observed
Target system / organ toxicity (F2)
- 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 considred to be in range of aboe 500-1500mg/kg bw/day for F0, F1 and F2 generation. When male and female CD rats were treated with test material orally.
- Executive summary:
Reproductive toxicity
Data available for the read across chemicals was reviewed to determine the reproductive toxicity of tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate (70161 -16 -9)The studies are as mentioned below:
Study 1
Three generation reproductive study of test material was performed on male and female Charles River CD rats. Animals were housed individually and fed the test diet ad libitum. The test material mixed with food in dose concentration 0, 5, 50, 150 or 500 mg/kg bw/day and 10 males and 20 females/group/generation were used .Pre-Mating Exposure / Males and Females were 60 days. Clinical observations were recorded twice daily with at least 5 hours between observations. Detailed physical examinations and palpation for masses were performed weekly. Body weights and food consumption were determined weekly for the first fourteen weeks, bi-weekly for the next 12 weeks and every 4 weeks thereafter until the end of the study. The intake of the test substance was determined from body weight, food consumption and dietary concentration. Haematology tests, including haemoglobin, haematocrit, erythrocyte and total and differential leukocyte counts, and erythrocyte morphology, were conducted on ten randomly selected animals at months 3, 6, 12, 18 and 24 of the study. Necropsies were conducted on all animals dying prior to study termination, killed in a moribund condition or killed on schedule. Histological examinations were conducted on all animals from both control groups, the highest dose group (2.0 or 5.0%) from each study and also on 10 rats randomly selected from each group for an interim sacrifice at 12 months. Histology was also performed on any animal with gross lesions or masses. Also tissues examined included adrenal glands, aorta, blood smear, brain, cecum, colon, duodenum, epididymus or uterus, esophagus, eyes, femur including marrow, tissue masses, gallbladder, heart, ileum, jejunum, duodenum, kidneys, liver, lungs and bronchi, mammary gland, nerves (sciatic), ovaries, lymph nodes, pancreas, parathyroids, pituitary gland, prostrate, rectum, skin, spleen, seminal vesicles, skeletal muscle, testes with epididymides, stomach, thymus, thyroid gland including parathyroid, trachea, urinary bladder, uterus.
At the end of study, no treatment-related effects were reported on survival. No treatment-related changes were reported at gross necropsy. Histological evaluation revealed a variety of lesions, including neoplasms, present at similar incidences in control and treated animals. The authors considered the lesions to be spontaneous and not related to administration of the test material. There were no compound related effects on fertility, gestation, pup viability or lactation indices, on reproductive organs of females, or on organ weights among parents and offspring. There were no compound related lesions in any tissue examined histologically, including kidneys and adrenal glands from parental rats or from offspring. There was no toxicity to either the F1 or F2 generation. Food consumption was similar for control and treated animals at the lower dietary levels, but was slightly higher in the high-dose study, although not statistically significant. Haematological, clinical chemistry and urinalysis parameters did not differ significantly from the controls. Necropsies at one year did not reveal any treatment-related gross or microscopic changes. Hence NOAEL was considered to be 500mg/kg bw/day for F0, F1 and F2 generation. When male and female Charles River CD rats were treated with test material orally.
Study 2
A multigeneration reproductive toxicity study of test material was performed on male and female wistar rats. The test material mixed with feed in dose concentration 0, 0.1, 1.0 or 3% (0, 50, 500, 1500 mg/kg bw per day) and administered orally for three successive generations. Each generation having 60 animals of each sex in the control and 40 animals of each sex in test animals. No adverse effects were observed with respect to fertility, litter size and weight, general condition, male/female ratio, growth during lactation, survival or maturation. Autopsy of parent rats and pups at weaning did not reveal any treatment related changes in organ weights other than caecal enlargement in the 3% dose group. Gross and microscopic examination of the F3 generation at weaning did not reveal any abnormalities due to treatment and no adverse effects were seen in the teratology study. It was concluded that Brilliant Black PN did not exert any adverse effects on reproductive function of Wistar rats when fed at dietary levels up to 3% (1500 mg/kg bw per day) for three successive generations. Therefore, NOAEL was considered to be at 3% (1500 mg/kg bw per day) for F0 F1 and F2 generation .When male and female wistar rats were treated with test material orally.
Thus, Based on the data available for the read across chemical, No Observed Adverse Effect Level (NOAEL) was considered to be above 500 -1500mg/kg bw . Thus, comparing this value with the criteria of CLP regulation tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate (70161 -16 -9) is not likely to classify as reproductive toxicant.
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