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EC number: 200-441-0 | CAS number: 59-67-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hazleton UK
- Limit test:
- no
Test material
- Reference substance name:
- Nicotinic acid
- EC Number:
- 200-441-0
- EC Name:
- Nicotinic acid
- Cas Number:
- 59-67-6
- Molecular formula:
- C6H5NO2
- IUPAC Name:
- nicotinic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material: Nicotinic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 28 days
- Weight at study initiation: At the start of the toxicity phase males weighed 165.1 to 211.2 g and females 118.0 to 149.1 g
- Fasting period before study: Overnight fast before laboratory investigations and necropsy
- Housing: The animals were caged in groups of 5 in stainless steel wire mesh cages suspended over cardboard-lined trays. The cardboard liners were replaced as often as was necessary to maintain hygiene.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: The animals were acclimatised in the study room for 7 days (palatability phase) or 14 days (toxicity phase) during which time their health status was reassessed and their suitability for experimental purposes confirmed.
ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25 °C
- Humidity: 40 to 70 %
- Air changes: 15 air changes/hour
- Photoperiod: Fluorescent lighting was controlled automatically to give a cycle of 12 hours light (0600 to 1800 h) and 12 hours darkness.
IN-LIFE DATES
- From: 17 July 1987
- To: 24 August 1987
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: The control article and vehicle for the test article was powdered diet.
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): Test diets were prepared weekly for each group and sex.
- Mixing appropriate amounts with (Type of food): The diet used was SQC Rat and Mouse Maintenance Diet No. 1, Expanded, Ground fine (Special Diets Services Ltd., Witham).
- Storage temperature of food: Room temperature - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Method
The analysis of the test diets was carried out using an analytical method supplied by the sponsor. The method contains a complex series of analytical procedures. The samples are acidified and extracted under pressure. Following filtration and centrifugation, the extract is submitted to ion exchange followed by HPLC.
Validation
The analytical procedure was validated by checking linearity, analytical recoveries and precision over the expected minimum and maximum concentration ranges.
Stability and Homogeneity
The stability and homogeneity of the test article in the diet was determined. Samples were taken from diet batches mixed at concentrations considered to be the highest and lowest likely in a subsequent chronic study in the rat. Stability samples were taken on the day of mixing and 7 and 14 days later and analyzed in triplicate. Homogeneity samples were taken from 3 levels (top, middle and bottom) of the bulk mix on the day of formulation and analyzed in duplicate.
Concentrations
Formulated diets from week 1 of treatment were analyzed in duplicate. - Duration of treatment / exposure:
- During the toxicity phase the test article was freely available for a minimum of 28 days up to the day of necropsy.
- Frequency of treatment:
- Continuous
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 250, 1000 mg/kg bw/day
Basis:
nominal in diet
- No. of animals per sex per dose:
- 5 male/5 female
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: Dose levels for the toxicity phase of the study were selected by the study sponsor.
- Rationale for animal assignment (if not random): The animals were assigned to treatment groups using a randomisation procedure based on stratified body weight during the acclimatisation period.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily
- All animals were examined twice daily to detect any which were dead or moribund.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: All toxicity phase animals were examined once daily for signs of ill health or overt toxicity. In addition each animal was given a detailed clinical examination at weekly intervals. An individual record was maintained of the clinical condition of each animal.
BODY WEIGHT: Yes
- Time schedule for examinations: Individual body weights were recorded before treatment on the first day of the study, at weekly intervals thereafter and at necropsy.
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- The amount of food consumed by each cage of animals was determined weekly in g/animal/week.
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Blood samples were obtained from all animals in week 4. The samples were collected by orbital sinus puncture.
- Anaesthetic used for blood collection: Yes (ether)
- Animals fasted: Yes (overnight, about 20 h)
- How many animals: 40
- Parameters examined: The following parameters were measured on blood collected into EDTA anticoagulant:
haemoglobin
mean cell volume
red blood cell count and indices:
mean cell haemoglobin
packed cell volume
mean cell haemoglobin concentration
total and differential white blood cell count platelets
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Blood samples were obtained from all animals in week 4. The samples were collected by orbital sinus puncture.
- Animals fasted: Yes (overnight, about 20 h)
- How many animals: 40
- Parameters examined: The following parameters were measured on blood collected into lithium heparin anticoagulant:
glutamate oxaloacetate transaminase
glutamate pyruvate transaminase
alkaline phosphatase
plasma (pseudo) cholinesterase
sodium
chloride
inorganic phosphorus
blood urea nitrogen
creatinine
albumin
total cholesterol
potassium
calcium
glucose
total bilirubin
total protein
albumin/globulin ratio
URINALYSIS: No
- There were no indications of treatment-related renal effects at week 4, consequently urine analysis was not carried out.
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
- Necropsy: The animals were killed by an intraperitoneal injection of sodium pentobarbitone and exsanguination following an overnight period without food. A full internal and external examination was made under the general supervision of a pathologist and all lesions were recorded. The necropsies were carried out on 1 day.
- Organ weights: The following organs were dissected free from fat and other contiguous tissue and weighed before fixation: adrenals, kidneys, liver, testes. Paired organs were weighed separately.
HISTOPATHOLOGY: Yes
- Histology: Samples of the following tissues were fixed in neutral buffered 10 % formalin: adrenals, heart, kidneys, liver, lungs (with mainstem bronchi), spleen, all gross lesions. Samples of tissues from the control and high dose animals and gross lesions from low and intermediate dose animals were embedded in paraffin wax B.P. (mp 56 °C), sectioned at a nominal thickness of 5 mm stained with haematoxylin and eosin and examined by the study pathologist. - Statistics:
- Data were processed. where appropriate. to give group mean values and standard deviations. Further statistical evaluation was considered not to be appropriate because of the small group size.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Slight reduction in body weight gain at 250 and 1000 mg/kg bw/day.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Slight increase in kidney weight at 250 and 1000 mg/kg bw/day.
- Gross pathological findings:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
There were no mortalities. There were no clinical observations recorded that were considered to be related to treatment.
BODY WEIGHT AND WEIGHT GAIN
Body weight gain in group 4 males and group 3 and 4 females was slightly reduced, resulting in decreased group mean body weight compared to controls. In group 4 male and female the reduction was ca. 7 %, in group 3 female ca. 12 %. See table 1 and 2.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
There were no apparent effects of treatment on the food consumption of the animals.
FOOD EFFICIENCY
Calculated test article intake was in good agreement with target dose levels.
HAEMATOLOGY
No effects of treatment on haematological parameters were apparent.
CLINICAL CHEMISTRY
Clinical chemistry parameters were apparently unaffected by treatment. Individual values for GOT, GPT and alkaline phosphatase were very variable. All data were within expected ranges and no clear trend was apparent. See tables 3 and 4.
URINE ANALYSIS
Urine analysis was not performed since clinical chemistry results did not suggest any treatment related effects.
ORGAN WEIGHTS
There were slight increases in combined relative kidney weight in group 3 female and group 4 male and female animals. Compared to their respective control groups the relative kidney weights of group 4 animals were 12 % greater. The mean relative weight of group 3 female kidneys was 8 % greater than that of the control group. See tables 5 to 8.
GROSS PATHOLOGY
There were no treatment-related findings at necropsy. There was no histopathological evidence of specific target organ toxicity in any of the tissues examined.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
ANALYSIS OF TEST DIETS
- Stability and homogeneity: The dietary formulations were stable for 14 days and formed homogeneous mixtures at the 2 concentrations investigated.
- Achieved concentrations: Formulations were within acceptable limits of nominal concentrations.
TABLE 1 | ||||||||||
Male animals: mean body weight (g) and standard deviation (S.D.) | ||||||||||
Week of study | control | 50 mg/kg bw /day | 250 mg/kg bw/day | 1000 mg/kg bw/day | ||||||
Start | Mean, S.D. | 187.7, 8.67 | 193.8, 10.93 | 180.7, 14.35 | 187.5, 5.58 | |||||
1 | Mean, S.D. | 238.9, 16.66 | 246.1, 13.43 | 229.2, 19.90 | 233.8, 8.08 | |||||
2 | Mean, S.D. | 282.3, 29.91 | 281.5, 19.51 | 264.9, 23.32 | 266.2, 10.87 | |||||
3 | Mean, S.D. | 311.1, 37.17 | 319.1, 24.94 | 295.0, 24.87 | 293.8, 14.74 | |||||
4 | Mean, S.D. | 321.0, 38.23 | 332.4, 29.82 | 311.3, 26.42 | 298.5, 18.10 | |||||
TABLE 2 | ||||||||||
Female animals: mean body weight (g) and standard deviation (S.D.) | ||||||||||
Week of study | control | 50 mg/kg bw /day | 250 mg/kg bw/day | 1000 mg/kg bw/day | ||||||
Start | Mean, S.D. | 136.1, 5.74 | 137.4, 12.30 | 133.5, 7.98 | 138.0, 7.24 | |||||
1 | Mean, S.D. | 163.5, 9.31 | 159.0, 14.12 | 150.4, 8.03 | 158.3, 7.66 | |||||
2 | Mean, S.D. | 179.4, 11.11 | 176.6, 15.35 | 162.3, 9.83 | 168.6, 11.47 | |||||
3 | Mean, S.D. | 198.2, 10.91 | 189.2, 15.61 | 174.7, 9.54 | 182.8, 15.17 | |||||
4 | Mean, S.D. | 199.8, 14.0 1 | 193.1, 15.57 | 176.7, 12.11 | 185.8, 14.71 | |||||
TABLE 3 | ||||||||||
Male animal group mean clinical chemistry Occasion: Week 4 |
||||||||||
Group | GOT (AST) Iu/L | GPT(ALT) Iu/L | ALK.PHOS Iu/L | P.CHE Iu/L | Na meq/L | K meq/L | Cl meq/L | Ca mg/dL | P mg/dL | |
1 | Mean, S.D. | 131, 42 | 46, 12 | 311, 36 | 61, 13 | 149, 2 | 4.0, 0.4 | 109, 1 | 10.3, 0.5 | 7.5, 0.5 |
2 | Mean, S.D. | 78, 59 | 44, 15 | 310, 91 | 68, 6 | 147, 2 | 4.1, 0.5 | 108, 1 | 10.2, 0.4 | 8.5, 0.4 |
3 | Mean, S.D. | 69, 54 | 43, 11 | 374, 50 | 66, 17 | 149, 3 | 4.0, 0.6 | 109, 1 | 10.7, 0.1 | 8.1, 1.1 |
4 | Mean, S.D. | 68, 32 | 44, 5 | 381, 70 | 55, 19 | 141, 0 | 3.9, 0.5 | 108, 1 | 10.4, 0.3 | 7.1, 0.7 |
TABLE 4 | ||||||||||
Female animal group mean clinical chemistry Occasion: Week 4 |
||||||||||
Group | GOT (AST) Iu/L | GPT(ALT) Iu/L | ALK.PHOS Iu/L | P.CHE Iu/L | Na meq/L | K meq/L | Cl meq/L | Ca mg/dL | P mg/dL | |
1 | Mean, S.D. | 87, 10 | 25, 4 | 183, 44 | 339, 134 | 148, 2 | 3.4, 0.3 | 111, 2 | 10.5, 0.3 | 6.3, 0.7 |
2 | Mean, S.D. | 106, 34 | 36, 6 | 235, 77 | 287, 108 | 147, 1 | 3.5, 0.5 | 111, 1 | 10.4, 0.2 | 6.1, 0.7 |
3 | Mean, S.D. | 99, 27 | 32, 6 | 266, 55 | 252, 42 | 147, 2 | 3.7, 0.2 | 108, 1 | 10.4, 0.1 | 7.1, 0.5 |
4 | Mean, S.D. | 102, 13 | 38, 11 | 252, 75 | 272, 93 | 147, 0 | 3.5, 0.4 | 109, 1 | 10.4, 0.2 | 6.8, 0.4 |
TABLE 3 cont. | ||||||||||
Male animal group mean clinical chemistry - Occasion: Week 4 | ||||||||||
Group | GLUCOSE mg/dL | B.U.N. mg/dL | T. BILI mg/dL | CREAT mg/dL | T. PROT g/dL | ALBUMIN g/dL | AG RATIO | TOT. CHOL mg/dL | ||
1 | Mean, S.D. | 90, 18 | 19, 3 | 0.2, 0.0 | 0.7, 0.1 | 6.3, 0.4 | 3.8, 0.1 | 1.5, 0.2 | 84, 15 | |
2 | Mean, S.D. | 100, 14 | 14, 1 | 0.2, 0.0 | 0.7, 0.1 | 6.2, 0.2 | 3.7, 0.1 | 1.5, 0.3 | 85, 13 | |
3 | Mean, S.D. | 92, 8 | 12, 1 | 0.2, 0.0 | 0.7, 0.1 | 6.3, 0.2 | 3.9, 0.1 | 1.6, 0.1 | 71, 13 | |
4 | Mean, S.D. | 104, 11 | 13, 2 | 0.2, 0.0 | 0.8, 0.0 | 6.3, 0.2 | 3.8, 0.1 | 1.5, 0.1 | 63, 4 | |
TABLE 4 cont. | ||||||||||
Female animal group mean clinical chemistry - Occasion: Week 4 |
||||||||||
Group | GLUCOSE mg/dL | B.U.N. mg/dL | T. BILI mg/dL | CREAT mg/dL | T. PROT g/dL | ALBUMIN g/dL | AG RATIO | TOT. CHOL mg/dL | ||
1 | Mean, S.D. | 91, 8 | 18, 2 | 0.2, 0.1 | 0.7, 0.1 | 6.3, 0.4 | 3.9, 0.1 | 1.6, 0.3 | 88, 22 | |
2 | Mean, S.D. | 99, 8 | 18, 3 | 0.2, 0.0 | 0.8, 0.1 | 6.2, 0.3 | 3.9, 0.1 | 1.7, 0.2 | 84, 10 | |
3 | Mean, S.D. | 109, 12 | 12, 1 | 0.1, 0.1 | 0.8, 0.0 | 6.2, 0.2 | 4.0, 0.3 | 1.8, 0.3 | 90, 12 | |
4 | Mean, S.D. | 106, 22 | 14, 3 | 0.2, 0.0 | 0.7, 0.1 | 6.2, 0.2 | 3.9, 0.2 | 1.7, 0.3 | 97, 25 | |
TABLE 5 | ||||||||||
Male animal group mean organ weight (g) at terminal kill | ||||||||||
Group | Bodyweight | AL | AR | KL | KR | LI | GL | GR | ||
1 | Mean, S.D. | 309.6, 39.6 | 0.023, 0.003 | 0.024, 0.004 | 0.948, 0.128 | 0.945, 0.129 | 7.992, 1.253 | 1.566, 0.163 | 1.547, 0.156 | |
2 | Mean, S.D. | 319.1, 28.5 | 0.029, 0.006 | 0.025, 0.004 | 0.969, 0.084 | 1.001, 0.066 | 8.697, 0.810 | 1.578, 0.171 | 1.602, 0.187 | |
3 | Mean, S.D. | 296.6, 26.0 | 0.026, 0.003 | 0.022, 0.005 | 0.955, 0.092 | 0.954, 0.064 | 8.015, 0.641 | 1.573, 0.071 | 1.585, 0.099 | |
4 | Mean, S.D. | 284.8, 18.8 | 0.024, 0.006 | 0.024, 0.007 | 0.988, 0.076 | 0.961, 0.061 | 7.375, 0.546 | 1.600, 0.180 | 1.581, 0.205 | |
TABLE 6 | ||||||||||
Female animal group mean organ weight (g) at terminal kill | ||||||||||
Group | Bodyweight | AL | AR | KL | KR | LI | ||||
1 | Mean, S.D. | 187.3, 14.3 | 0.029, 0.003 | 0.026, 0.004 | 0.635, 0.093 | 0.661, 0.077 | 5.504, 0.461 | |||
2 | Mean, S.D. | 183.2, 17.4 | 0.031, 0.009 | 0.030, 0.005 | 0.647, 0.034 | 0.652, 0.054 | 5.569, 0.582 | |||
3 | Mean, S.D. | 167.7, 12.5 | 0.026, 0.005 | 0.024, 0.008 | 0.613, 0.063 | 0.630, 0.038 | 5.364, 0.335 | |||
4 | Mean, S.D. | 175.7, 13.1 | 0.032, 0.003 | 0.032, 0.003 | 0.616, 0.052 | 0.642, 0.053 | 5.475, 0.607 | |||
TABLE 7 | ||||||||||
Male animal group mean organ/body weight (%) | ||||||||||
Group | Bodyweight | AL | AR | KL | KR | LI | GL | GR | ||
1 | Mean, S.D. | 309.6, 39.6 | 0.0074, 0.0007 | 0.0071, 0.0011 | 0.3062, 0.0186 | 0.3053, 0.0183 | 2.5745, 0.1553 | 0.5091, 0.0483 | 0.5027, 0.0452 | |
2 | Mean, S.D. | 319.1, 28.5 | 0.0092, 0.0018 | 0.0080, 0.0014 | 0.3044, 0.0213 | 0.3148, 0.0241 | 2.7257, 0.0838 | 0.4955, 0.0461 | 0.5024, 0.0456 | |
3 | Mean, S.D. | 296.6, 26.0 | 0.0087, 0.0010 | 0.0075, 0.0018 | 0.3221, 0.0161 | 0.3221, 0.0103 | 2.7048, 0.0859 | 0.5329, 0.0400 | 0.5368, 0.0464 | |
4 | Mean, S.D. | 284.8, 18.8 | 0.0085, 0.0018 | 0.0083, 0.0022 | 0.3471, 0.0216 | 0.3383, 0.0252 | 2.5919, 0.1480 | 0.5645, 0.0844 | 0.5578, 0.0903 | |
TABLE 8 | ||||||||||
Female animal group mean organ/body weight (%) | ||||||||||
Group | Bodyweight | AL | AR | KL | KR | LI | ||||
1 | Mean, S.D. | 187.3, 14.3 | 0.0154, 0.0016 | 0.0141, 0.0014 | 0.3379, 0.0299 | 0.3522, 0.0192 | 2.9386, 0.1127 | |||
2 | Mean, S.D. | 183.2, 17.4 | 0.0167, 0.0038 | 0.0162, 0.0026 | 0.3548, 0.0224 | 0.3578, 0.0374 | 3.0390, 0.1241 | |||
3 | Mean, S.D. | 167.7, 12.5 | 0.0156, 0.0032 | 0.0142, 0.0043 | 0.3669, 0.0408 | 0.3767, 0.0280 | 3.2170, 0.3723 | |||
4 | Mean, S.D. | 175.7, 13.1 | 0.0180, 0.0011 | 0.0184, 0.0028 | 0.3857, 0.0306 | 0.3887, 0.0193 | 3.1117, 0.1493 |
Applicant's summary and conclusion
- Conclusions:
- There was no effect of oral administration of test item in the diet at a dose level of 50 mg/kg/day for 28 days. At 250 and 1000 mg/kg/day there was a slight reduction in body weight gain and a slight increase in relative kidney weight. There was, however, no histopathological evidence of systemic toxicity.
- Executive summary:
A study according to EU Method B.7 and OECD 407 (Repeated dose toxicity – oral) was carried out. The objectives of the study were to determine the palatability and oral toxicity of test item in the rat following administration for 28 days.
A total of 4 groups of 5 male and 5 female rats were offered test item admixed in the diet at dose levels of 0, 50, 250 and 1000 mg/kg bw/day. The dietary formulations were stable for 14 days and were homogeneous at the concentrations investigated. Week 1 formulations were accurately prepared.
There were no mortalities and no treatment-related observations. There were reductions in the body weight and body weight gain of female animals dosed at 250 mg/kg bw/day and male and female animals dosed at 1000 mg/kg bw/day. No treatment-related effects on food consumption were apparent. There were no effects of treatment on the hematological and clinical chemistry parameters measured. A slight increase in relative kidney weight in female animals dosed at 250 mg/kg bw/day and male and female animals dosed at 1000 mg/kg bw/day was the only apparent effect on organ weight. There was no gross or histopathologic evidence of toxicity in any of the tissues examined.
In conclusion, there was no effect of oral administration of test item in the diet at a dose level of 50 mg/kg/day for 28 days. At 250 and 1000 mg/kg/day there was a slight reduction in body weight gain and a slight increase in relative kidney weight. There was, however, no histopathologic evidence of systemic toxicity.
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