Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-505-6 | CAS number: 107-58-4
- 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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Experimental result using OECD recommended guidelines
- Justification for type of information:
- Data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Repeated Dose 28 days Study of the test chemical in rats.
- GLP compliance:
- yes
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: Solid
- Details on test material:
- - Name of test material (as cited in study report): N-tert-butylacrylamide
- Molecular formula (if other than submission substance): C7H13NO
- Molecular weight (if other than submission substance): 127.19 g/mole
- Substance type: Organic
- Physical state: Solid
- Impurities (identity and concentrations): 0.29 %
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-House Bred at sa-FORD, Animal Facility
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: Male : 137-191 g, Female: 137- 165 g
- Fasting period before study: No data available
- Housing: Animals were housed in Polycarbonate cages. Cage rotation was carried out weekly and cleaned at regular intervals. Animals were bedded on sterilized corn cob produced from pure corn, dried and free from dust. Floor of the experimental room and work tops were swept and mopped with disinfectant solution every day or as on requirement.
- Diet (e.g. ad libitum): A conventional laboratory pelleted diet, ad libitum.
- Water (e.g. ad libitum): Aqua guard filtered drinking water in bottles, ad libitum.
- Acclimation period: Male: 6 days, Female: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.00 to 23.10 °C
- Humidity (%): 49.90 to 69.40%.
- Air changes (per hr): Adequately filtered air 12 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark artificial light.
IN-LIFE DATES: From: September 22, 2014
To: October 20, 2014
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Substance was weighed and dissolved in a vehicle (corn oil) to achieve desired concentration of test item. Dose formulation was freshly prepared daily. At the time of dosing, dose formulation was kept on the magnetic stirrer to maintain the homogeneity of test item.
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Corn oil was used as a vehicle based on the solubility testing.
- Concentration in vehicle: 0,125,250 and 500 mg/kg/day
- Amount of vehicle (if gavage): 1 ml/100g body weight
- Lot/batch no. (if required): MKBQ9948V and MKBG9426V
- Purity: No data available - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Stability and concentration of the substance in dose formulation was analysed by a validated analytical method, at the start of treatment (on day 1) and on day 21.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: mg/kg/day
- Dose / conc.:
- 125 other: mg/kg/day
- Dose / conc.:
- 250 other: mg/kg/day
- Dose / conc.:
- 500 other: mg/kg/day
- No. of animals per sex per dose:
- Total : 60
0 mg/kg/day: 5 male, 5 female
125 mg/kg/day: 5 male, 5 female
250 mg/kg/day: 5 male, 5 female
500 mg/kg/day: 5 male, 5 female
Recovery:
0 mg/kg/day: 5 male, 5 female
500 mg/kg/day: 5 male, 5 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The dose levels were selected based on the information provided by Sponsor.
- Rationale for animal assignment (if not random): No data available
- Rationale for selecting satellite groups: No data available
- Post-exposure recovery period in satellite groups: No data available
- Section schedule rationale (if not random): No data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily (morning and evening)
- Cage side observations checked in table [No.?] were included: Morbidity and mortality were observed.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once before the first treatment and weekly thereafter.
BODY WEIGHT: Yes
- Time schedule for examinations: At start of treatment and thereafter weekly.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available
FOOD EFFICIENCY: No data available
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
- Time schedule for examinations: No data available
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: Prior to treatment (During Acclimatization Period) and at the end of the dosing (main groups) and recovery periods (recovery group) were examined.
- Dose groups that were examined: All 60 animals were examined.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: On termination day, just prior to necropsy.
- Anaesthetic used for blood collection: No data available
- Animals fasted: Yes, overnight (approximately 16-18 hr).
- How many animals: All 60 animals were examined.
- Parameters checked in table [No.?] were examined: Total Erythrocyte Count (RBC), Hematocrit (HCT), Mean Corpuscular Volume (MCV), Hemoglobin (HGB), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Platelet Count (PLT), Total Leukocyte count (WBC), Prothombin Time (PT) and Activated Partial Thromboplastin time (aPTT) were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: On termination day, just prior to necropsy.
- Animals fasted: Yes, overnight (approximately 16-18 hr).
- How many animals: All 60 animals were examined.
- Parameters checked in table [No.?] were examined: Glucose (Glu), Cholesterol (Chol), Triglycerides (TRIG), Alanine amino transferase (ALT), Aspartate amino transferase (AST), Gamma-Glutamyl Transpeptidase (GGT), Calcium, Creatine Kinase (CK), Albumin, Total Protein (TP), Creatinine (Crea), Total Bilirubin (T.Bil), Phosphorus, Alkaline phosphatase (ALP), Urea, Lactate Dehydrogenase (LD), Sodium (Na), Potassium (K), Chloride (Cl), Blood urea nitrogen (BUN), Globulin (Glob), A/G and Bile acids were examined.
URINALYSIS: Yes
- Time schedule for collection of urine: No data available
- Metabolism cages used for collection of urine: Yes
- Animals fasted: No data available
- Parameters checked in table [No.?] were examined: Colour, appearance, urine volume, Blood / Blood Cell, Bilirubin, Urobilinogen, Ketone, Protein, Nitrite, Glucose, pH, Specific Gravity, Leucocytes, Microscopical Parameters were examined.
NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: sensory activity / grip strength / motor activity / other: Yes, Sensory reactivity to stimuli, grip strength, hind limb foot splay and motor activity were tested.
OTHER:
Organ weight: Absolute and relative organ weights were examined.
Organ examined: Liver, kidneys, adrenals, testes, epdidymides, Prostate and Seminal vesicle with coagulating glands, uterus with cervix, ovary with oviduct, thymus, spleen, brain and heart were examined.
Bone Marrow Smear were also examined - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
All animals were fasted overnight before necropsy. Animals were sacrificed by using over dose of CO2 and examined externally and macroscopically.
HISTOPATHOLOGY: Yes
All tissues were preserved in 10 % neutral buffered formalin (except eyes and testes; which were fixed using Modified Davidson fluid for 24 hr and then transferred to 10 % neutral buffered formalin (NBF) for preservation) for subsequent histopathological examintion.
Organ examined:
Adrenals, Bone (femur) with joint, Brain (cerebrum,cerebellum,mid brain), Cecum, Colon, Duodenum, Epididymides, Eyes with optic nerve, Gross lesion, Ileum, Jejunum, Kidneys, Liver, Lung, Mammary glands, Mesenteric and Mandibular lymph node, Oesophagus and Ovary with oviduct were examined. - Other examinations:
- No data available
- Statistics:
- Statistical analysis of raw data was performed by using statistical software Sigma Plot 11.0. The mean and standard deviation was calculated using the software and all data was summarized in tabular form. All continuous data (body weight, feed consumption, haematology, clinical chemistry, absolute and relative organ weights) were checked for their homogeneity using Bartlett’s test. All homogenous data was analysed using ANOVA and data showing significance in their variances was subjected to Dunnett’s t-test. All heterogeneous data was analysed using F test and Student’s t-test.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Mortality:
No mortality and morbidity was observed in treated male and female rat as compare to control.
Clinical signs:
No clinical sign were observed in treatment and recovery dosed male and female rat as compare to control.
Body weight and weight gain: When treated with 500 mg/kg/day body weight, in female rat statistically significant decreased in body weight gain were observed as compare to control.
No change was observed in 125 and 250 mg/kg/day body weight treated male and female rats as compare to control.
Food consumption and compound intake: No change was observed in food consumption of treated male and female rat in treatment and recovery period as compare to control.
Food efficiency: No data available
Water consumption and compound intake: No data available
Opthalmoscopic examination: No abnormalities were observed in treated male and female rat in treatment and recovery period as compare to control.
Haematology: When treated with 500 mg/kg/day body weight, in female rat statistically significant increase neutrophil were observed.
In recovery, statistically significant decrease was observed in MCV and WBC and increase observed in PLT in females and statistically significant decrease in APTT in male rat as compare to control.
Above changes were not related to the test substence and may due to the preanalytical and analytical variables.
Clinical chemistry: When treated with 125, 250 and 500 mg/kg/day body weight, in male rat statistically significant increase were observed in Sodium (Na) and decrease in Lactate Dehydrogenase (LD) and Creatine Kinase (CK) when treated with 125 and 500 mg/kg/day body weight.
When treated with 250 and 500 mg/kg/day body weight, Statistically significant increase was observed in Alkaline phosphatase (ALP) in male rat.
When treated with 500 mg/kg/day body weight, Alanine amino transferase (ALT) increased in male rat as compare to control.
In recovery, Statistically significant increase were observed in Blood urea nitrogen (BUN), Urea, Albumin (ALB), Alkaline phosphatase (ALP), Potassium (K), Chloride (Cl) and Bile acids and statistically significant decrease in Cholesterol (Chol) in male rat and Sodium (Na) in female rat as compare to control.
Urinanalysis: No change was observed in urine analysis of treated animals in treatment and recovery period as compare to control.
Neurobehaviour: No data available
Organ weights: In male rat, relative weight of liver were significantly increase in 250 and 500 mg/kg/day body weight.
Relative organ weight of kidney showed statistically significant increase when treated with in 250 and 500 mg/kg/day body weight.
Absolute and relative organ weight of S.V. with coagulating gland and prostrate as whole was decreased in 250 mg/kg/day body weight in male rat as compare to control.
In female absolute weight of liver showed significantly decrease in 125 mg/kg/day body weight.
In recovery, in female absolute and relative organ weight of Adrenals was increased and absolute organ weight of kidney was decreased when treated with 500 mg/kg/day body weight and absolute and relative organ weight of spleen was decreased in 250 mg/kg/day body weight.
In male, significant difference were observed in absolute & relative weight of liver in male rat when treated with 250 and 500 mg/kg/day body weight.
Gross pathology: No external and internal abnormal changes were observed in treated male and female rats in treatment and recovery period as compare to control.
Histopathology: When treaed with 500 mg/kg/day body weight, hyperplasia of BALT in Lung and MNC infiltration in trachea were observed in male and female this effect was reversed in 14 days recovery period.
These observed changes are inflammatory changes and are the most common observed changes in rodents.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effect on survival, body weight, food consumption, battery test, hematology, clinical chemistry, organ weight, gross pathology and histopathology.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Mortality and Morbidity
Group | Treatment | Dose (mg/kg b.wt.) | No. of Animals/ Group | Day of Observations | Observation |
G1 | Control | 0 | 5 | 1-29 | NMM |
G2 | Low | 125 | 5 | 1-29 | NMM |
G3 | Mid | 250 | 5 | 1-29 | NMM |
G4 | High | 500 | 5 | 1-29 | NMM |
G1-R | Control -Recovery | 0 | 5 | 1-43 | NMM |
G4-R | High- Recovery | 500 | 5 | 1-43 | NMM |
Group | Treatment | Dose (mg/kg b.wt.) | No. of Animals/ Group | Day of Observations | Observation |
G1 | Control | 0 | 5 | 1-29 | NMM |
G2 | Low | 125 | 5 | 1-29 | NMM |
G3 | Mid | 250 | 5 | 1-29 | NMM |
G4 | High | 500 | 5 | 1-29 | NMM |
G1-R | Control -Recovery | 0 | 5 | 1-43 | NMM |
G4-R | High- Recovery | 500 | 5 | 1-43 | NMM |
Key:NMM = No mortality and morbidity observed.
Mean Absolute Organ Weight (g)
Sex:Male
Organs
| Group 1 | Group 2 | Group 3 | Group 4 | ||||
Mean | SD | Mean | SD | Mean | SD | Mean | SD | |
Body weight (g) | 251.80 | 21.09 | 239.20 | 24.78 | 240.60 | 18.37 | 234.60 | 11.48 |
Brain | 1.910 | 0.062 | 1.935 | 0.053 | 1.966 | 0.051 | 1.900 | 0.057 |
Adrenals | 0.046 | 0.013 | 0.059 | 0.007 | 0.053 | 0.009 | 0.051 | 0.010 |
S.V. With Coagulating gland and prostrate | 1.1831 | 0.22882 | 1.11382 | 0.167243 | 0.8658↓ | 0.1214 | 1.1246 | 0.12127 |
Testes | 3.003 | 0.246 | 2.857 | 0.296 | 2.966 | 0.167 | 2.810 | 0.150 |
Epdidymides | 0.902 | 0.164 | 1.004 | 0.135 | 0.958 | 0.106 | 0.954 | 0.045 |
Heart | 1.044 | 0.088 | 1.007 | 0.078 | 0.998 | 0.069 | 0.911 | 0.043 |
Liver | 10.450 | 0.919 | 11.804↑ | 1.553 | 13.062↑ | 1.580 | 13.492↑ | 1.428 |
Kidneys | 2.294 | 0.219 | 2.271 | 0.261 | 2.575 | 0.202 | 2.427 | 0.192 |
Spleen | 1.356 | 0.434 | 1.142 | 0.332 | 1.136 | 0.196 | 0.905 | 0.198 |
Thymus | 0.301 | 0.071 | 0.311 | 0.044 | 0.299 | 0.071 | 0.241 | 0.056 |
Organs
| Group 1-R | Group 4-R | ||
Mean | SD | Mean | SD | |
Body weight (g) | 273.40 | 20.21 | 280.80 | 15.39 |
Brain | 1.935 | 0.120 | 1.927 | 0.067 |
Adrenals | 0.056 | 0.009 | 0.064 | 0.008 |
S.V. With Coagulating gland and prostrate | 1.5541 | 0.4754 | 1.4925 | 0.260007 |
Testes | 3.210 | 0.166 | 3.168 | 0.254 |
Epdidymides | 1.145 | 0.063 | 1.112 | 0.153 |
Heart | 1.148 | 0.080 | 1.175 | 0.125 |
Liver | 10.861 | 0.878 | 10.788 | 0.658 |
Kidneys | 2.417 | 0.304 | 2.368 | 0.199 |
Spleen | 1.002 | 0.106 | 1.048 | 0.285 |
Thymus | 0.296 | 0.106 | 0.349 | 0.090 |
Sex:Female
Organs | Group 1 | Group 2 | Group 3 | Group 4 | ||||
Mean | SD | Mean | SD | Mean | SD | Mean | SD | |
Body weight (g) | 185.40 | 15.13 | 173.00 | 4.00 | 178.40 | 7.37 | 169.60 | 5.41 |
Brain | 1.791 | 0.076 | 1.692 | 0.091 | 1.728 | 0.040 | 1.789 | 0.087 |
Adrenals | 0.059 | 0.011 | 0.051 | 0.011 | 0.061 | 0.011 | 0.064 | 0.012 |
Ovary | 0.092 | 0.012 | 0.106 | 0.032 | 0.111 | 0.024 | 0.091 | 0.015 |
Uterus | 0.720 | 0.120 | 0.645 | 0.107 | 0.561 | 0.152 | 0.553 | 0.115 |
Heart | 0.853 | 0.118 | 0.725 | 0.027 | 0.731 | 0.063 | 0.725 | 0.079 |
Liver | 8.231 | 0.754 | 7.106↓ | 0.640 | 7.743 | 0.646 | 8.403 | 0.586 |
Kidneys | 1.582 | 0.132 | 1.412 | 0.098 | 1.470 | 0.097 | 1.585 | 0.177 |
Spleen | 0.719 | 0.279 | 0.502 | 0.122 | 0.485 | 0.120 | 0.516 | 0.225 |
Thymus | 0.300 | 0.049 | 0.266 | 0.081 | 0.235 | 0.036 | 0.242 | 0.042 |
Organs | Group 1-R | Group 4-R | ||
Mean | SD | Mean | SD | |
Body weight (g) | 196.60 | 9.96 | 188.40 | 8.50 |
Brain | 1.792 | 0.087 | 1.800 | 0.059 |
Adrenals | 0.077 | 0.007 | 0.090↑ | 0.006 |
Ovary | 0.164 | 0.015 | 0.170 | 0.018 |
Uterus | 0.777 | 0.305 | 0.723 | 0.120 |
Heart | 0.846 | 0.054 | 0.782 | 0.045 |
Liver | 7.429 | 0.677 | 7.394 | 0.560 |
Kidneys | 1.684 | 0.058 | 1.522↓ | 0.110 |
Spleen | 0.776 | 0.126 | 0.441↓ | 0.054 |
Thymus | 0.281 | 0.062 | 0.320 | 0.037 |
Applicant's summary and conclusion
- Conclusions:
- The No observed adverse effect level (NOAEL) was considered to be 500 mg/kg/day body weight when male and female rat were exposed to the test chemical.
- Executive summary:
In a repeated dose toxicity study, male and female Wistar rats were exposed to the test chemical orally in the concentration of 0, 125, 250 and 500 mg/kg/day body weight. No substance related toxic changes were obsrved in survival, body weight, food consumption,hematology, clinical chemistry,battery test and urinalysis of treated rats. Significant change in liver, kidney,Adrenals and spleen of 250 and 500 mg/kg bw/day treated rats as compared to control. In addition, no gross pathological and histopathological changes were observed in male and female rats. Some changes were observed but they are not test substance related.Therefore, No observed adverse effect level (NOAEL) was considered to be 500 mg/kg/day body weight when rats are exposed to the test chemical orally for 28 days.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

Route: .live1