Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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: 205-766-1 | CAS number: 150-68-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1978
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Toxicology and Carcinogenesis Studies of Monuron (CAS No.150-68-5) in F344/N Rats and B6C3F1 Mice (Feed Studies)
- Author:
- US National Toxicology Program, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, Public Health Service National Institutes of Health
- Year:
- 1 988
- Bibliographic source:
- US National Toxicology Program Technical Report Series No. 26 (1988)
- Reference Type:
- review article or handbook
- Title:
- IARC Monographs on the evaluation of carcinogenic risks to humans, Volume 53, Occupational Exposures in Insecticide Application, and Some Pesticides
- Author:
- International Agency for Research on Cancer (IARC)
- Year:
- 1 991
- Bibliographic source:
- IARC Monographs Volume 53 Sup 7 (1991) p.467-480
Materials and methods
Test material
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot no. D-A330 obtained from the Hopkins Chemical Co. (Madison, WI) in one lot
- Expiration date of the lot/batch: The purity and identity determinations were made three times per year at the Study Laboratory and showed that the chemical maintained its identity and purity throughout the studies.
- Purity test date: Not provided.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: A heat stability study performed by the analytical chemistry laboratory indicated that the compound was stable in storage. After receiving the study chemical from the analytical chemistry laboratory, the study laboratory stored it at 0° ± 5° C. Periodic characterization of the chemical at EG&G Mason Research Institute by infrared spectroscopy and thin-layer chromatography indicated that no detectable decomposition occurred during the studies.
- Stability under test conditions: Monuron was stable in feed when stored for 2 weeks at 25°C or below.
- Solubility and stability of the test substance in the solvent/vehicle: Monuron was stable in feed when stored for 2 weeks at 25°C or below.
The mixture of monuron in stock rodent feed at the 0.5% (5000 ppm) concentration was more homogenous after 15 minutes than after 10 minutes mixing in a 4-qt Patterson-Kelly Twin-Shell® blender with intensifier bar. The variations in the samples of the 15-minute mixture are within 10% of the target concentration of chemical in the feed.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:After receiving the study chemical from the analytical chemistry laboratory, the study laboratory stored it at 0° ± 5° C.
- Final preparation of a solid: The study laboratory prepared formulated diets by layering a dry premix between portions of feed and blending the mixture for 15 minutes.
1.Premix: Monuron (7.54 g ± 0.01 g) was added directly to 100 g of Wayne Lab Blox® rodent feed.
This premixture was homogenized in a 1-qt large-mouth glass jar rotated for 15 minutes on a ball-mill type tumbler apparatus, with manual end-over-end tumbling every 5 minutes.
2.Bulk mixing: The above premix and 1400 g more feed were mixed in a Patterson-Kelly Twin-Shell® blender for 15 minutes. The blender was loaded from the top of the shells as follows: 700 g of feed
was poured in and allowed to settle and level at the bottom (vertex of the "V"); then the dried premix was poured in on top of the feed from each side; this layer was covered with the remaining 700 g
of feed poured in from each side. After 10-and 15minute mixing times, duplicate 5-g samples were removed from the top of each shell and the bottom trap of blender for subsequent analysis.
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Remarks:
- F344/N
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Industries, Inc. (Indianapolis, IN)
- Age at study initiation (when placed on study): 7-8 wk
- Housing: Polycarbonate cages (Lab Products, Inc., Rochelle Park, NJ) with Nonwoven fiber cage filters (Lab Products, Inc., Rochelle Park, NJ) and Aspen Bed® hardwood chips (American Excelsior
Co., Baltimore, MD) as bedding material; 5 animals per cage
- Diet (e.g. ad libitum): Wayne Lab Blox® (Allied Mills, Inc., Chicago, IL); ad libitum
- Water (e.g. ad libitum): Tap, available ad libitum via automatic watering system (Edstrom Industries, Waterford, WI)
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° C average, range 19°-26° C
- Humidity (%): 23.9% average relative humidty; range 7%-55%
- Air changes (per hr): 10 changes room air/h
- Photoperiod (hrs dark / hrs light): fluorescent light 12 h/d
IN-LIFE DATES:
From: First dosing: 25 September 1978
To: 26 December 1978 – 29 December 1978 (killed at 20-21 wks old)
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): Maximum Storage Time: 14 days.
- Mixing appropriate amounts with (Type of food): Wayne Lab Blox® (Allied Mills, Inc., Chicago, IL).
The study laboratory prepared formulated diets by layering a dry premix between portions of feed and blending the mixture for 15 minutes.
1.Premix: Monuron (7.54 g ± 0.01 g) was added directly to 100 g of Wayne Lab Blox® rodent feed.
This premixture was homogenized in a 1-qt large-mouth glass jar rotated for 15 minutes on a ball-mill type tumbler apparatus, with manual end-over-end tumbling every 5 minutes.
2.Bulk mixing: The above premix and 1400 g more feed were mixed in a Patterson-Kelly Twin-Shell® blender for 15 minutes. The blender was loaded from the top of the shells as follows: 700 g of feed
was poured in and allowed to settle and level at the bottom (vertex of the "V"); then the dried premix was poured in on top of the feed from each side; this layer was covered with the remaining 700 g
of feed poured in from each side. After 10-and 15minute mixing times, duplicate 5-g samples were removed from the top of each shell and the bottom trap of blender for subsequent analysis.
- Storage temperature of food: The mixture was held at 5°C until use and was used within 13 days after being mixed. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The analytical chemistry laboratory demonstrated the homogeneity of a formulated diet mixture. Further studies showed that monuron was stable in feed when stored for 2 weeks at 25°C or below.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- continuous exposure in the food
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Remarks:
- target concentration
- Dose / conc.:
- 750 ppm
- Remarks:
- target concentration
- Dose / conc.:
- 1 500 ppm
- Remarks:
- target concentration
- Dose / conc.:
- 3 000 ppm
- Remarks:
- target concentration
- Dose / conc.:
- 6 000 ppm
- Remarks:
- target concentration
- Dose / conc.:
- 12 000 ppm
- Remarks:
- target concentration
- Dose / conc.:
- 0 ppm
- Remarks:
- experimental mean concentration
- Dose / conc.:
- 900 ppm
- Remarks:
- experimental mean concentration
- Dose / conc.:
- 1 800 ppm
- Remarks:
- experimental mean concentration
- Dose / conc.:
- 3 200 ppm
- Remarks:
- experimental mean concentration
- Dose / conc.:
- 7 200 ppm
- Remarks:
- experimental mean concentration
- Dose / conc.:
- 12 400 ppm
- Remarks:
- experimental mean concentration
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Rationale for animal assignment: Distributed to groups so that average group weights approximately equal
Examinations
- Observations and examinations performed and frequency:
- CLINICAL SIGNS AND MORTALITY
Animals were checked two times per day; moribund animals were killed, and necropsies were performed.
BODY WEIGHT AND WEIGHT GAIN
Individual animal weights were recorded once per week.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
Feed consumption was measured once per week. One day before the animals were killed, formulated diets were replaced with control feed.
GROSS PATHOLOGY
At the end of the 13-week studies, survivors were killed. A necropsy was performed on all animals, except those excessively autolyzed or cannibalized. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes. At the end of the 13-week studies, survivors were killed. A necropsy was performed on all animals, except those excessively autolyzed or cannibalized.
HISTOPATHOLOGY: Yes. Histologic exam performed on control, 6000-, and 12000-ppm groups and early death rats: gross lesions and tissue masses, mandibular lymph nodes, mammary gland,
salivary glands, thyroid gland, parathyroids, sternebrae, liver, colon, small intestine, prostate/testes or ovaries/uterus, urinary bladder, lungs and bronchi, heart, esophagus, stomach, brain, thymus, trachea, pancreas, spleen, kidneys, adrenal glands, pituitary gland, spinal cord and eyes.
Partial histologic exam on 3000-ppm group: thymus, bone marrow, spleen, mesenteric and mandibular lymph nodes.
Results and discussion
Results of examinations
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 8/10 male rats and 9/10 female rats fed diets containing 12000 ppm monuron died during the first 2 weeks of the studies.
5/10 male rats and 6/10 female rats fed diets containing 6000 ppm monuron died during the first 4 weeks of the studies. - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The final weights of the rats were inversely related to the concentration of monuron in the feed.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Female rats fed 750-12000 ppm ate less than did the controls.
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Discoloration and mottling of the lungs, smoothing and thinning of the stomach, and enlargement and discoloration of the adrenal glands were noted at necropsy and appeared to be compound related.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- A generalized atrophy of lymphocytic and hematopoietic tissues was observed in male and female rats fed diets containing 12000 ppm monuron. These changes included lymphoid depletion and
congestion of the splenic white pulp, lymphoid depletion with overall reduction in size of the thymus, myeloid depletion of bone marrow, and lymphoid depletion of B-and T-cell areas of lymph nodes
causing a marked reduction in the size of all examined lymph nodes. Similar but less severe changes were seen in male and female rats fed diets containing 6000 ppm monuron; changes seen in the l
ymphocytic and hematopoietic tissues of rats fed monuron at lower concentrations were considered to be slight or equivocal.
Effect levels
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 5 mg/kg diet
Target system / organ toxicity
open allclose all
- Critical effects observed:
- yes
- System:
- haematopoietic
- Treatment related:
- yes
- Critical effects observed:
- yes
- Organ:
- kidney
- Treatment related:
- yes
- Critical effects observed:
- yes
- Organ:
- liver
- Treatment related:
- yes
Applicant's summary and conclusion
- Conclusions:
- In a 13 weeks feeding study, dietary uptake of monuron (>99% pure) of up to 12000 ppm in Fischer 344 rats, the kidney, liver and lympho/haematopoietic systems were targets for toxicity. The lympho/hematopoietic system of rats was the primary site affected. The Iymphocytic and haematopoietic tissue atrophy seen in rats at high doses in the 13-week studies was not seen in the two-year feeding studies.
Because of weight gain depression and histopathologic changes observed at higher dose levels, doses selected for the 2-year studies in rats were 750 and 1500 ppm monuron in feed. - Executive summary:
Thirteen-week studies were conducted to evaluate the toxicity associated with repeated ingestion of monuron and to determine the concentrations to be used in the 2-year studies.
Groups of 10 F344/N rats of each sex were fed diets containing 0, 750, 1500, 3000, 6000, or 12000 ppm monuron. All diets were available ad libitum. Formulated diets were first offered to each group on September 25, 1978. Necropsies were performed between December 26 and December 29, 1978.
Animals were checked two times per day, moribund animals were killed and necropsies were performed. Feed consumption was measured once per week. One day before the animals were killed, formulated diets were replaced with control feed. Individual animal weights were recorded once per week. At the end of the 13 week studies, survivors were killed. A necropsy was performed on all animals, except those excessively autolyzed or cannibalized.
Eight of 10 male rats and 9/10 female rats fed diets containing 12000 ppm monuron died during the first 2 weeks of the studies. Five of 10 male rats and 6/10 female rats fed diets containing 6000 ppm monuron died during the first 4 weeks of the studies. The final weights of the rats were inversely related to the concentration of monuron in the feed. Female rats fed 750-12000 ppm ate less than did the controls.
Discoloration and mottling of the lungs, smoothing and thinning of the stomach, and enlargement and discoloration of the adrenal glands were noted at necropsy and appeared to be compound related.
A generalized atrophy of lymphocytic and hematopoietic tissues was observed in male and female rats fed diets containing 12000 ppm monuron. These changes included lymphoid depletion and congestion of the splenic white pulp, lymphoid depletion with overall reduction in size of the thymus, myeloid depletion of bone marrow, and lymphoid depletion of B-and T-cell areas of lymph nodes causing a marked reduction in the size of all examined lymph nodes. Similar but less severe changes were seen in male and female rats fed diets containing 6000 ppm monuron; changes seen in the lymphocytic and hematopoietic tissues of rats fed monuron at lower concentrations were considered to be slight or equivocal.
Because of weight gain depression and histopathologic changes observed at higher dose levels, doses selected for the 2-year studies in rats were 750 and 1500 ppm monuron in feed.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Mimo że ECHA udostępnia wiele materiałów online w Twoim języku, część tej strony jest dostępna tylko w języku angielskim. Więcej o praktykach ECHA związanych z mwielojęzycznością.
Witamy na stronie internetowej ECHA. Strona ta nie jest w pełni obsługiwana przez Internet Explorer 7 (i wcześniejsze wersje). Prosimy o zainstalowanie nowszej wersji Internet Explorer.
Niniejsza strona używa plików cookies, aby zapewnić optymalne korzystanie z naszych stron internetowych.
Dodatkowe informacje: jak używamy plików cookies.