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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
Endpoint summary
Administrative data
Description of key information
Several acute oral toxicity studies were performed in rats with key lowest LD50 value in adult male and female rats of 1226 and 1053 mg/kg bw , respectively, and 2232 mg/kg bw in male weanling rats. Supporting studies showed oral LD50 value up to 3600 mg/kg bw in rats and 1920 mg/kg bw in mice.
Acute inhalation toxicity was waived based upon the low vapor pressure of Monuron (5.03E-07 mm Hg).
Acute dermal toxicity studies were performed in rats and rabbits, with key LD50 value in adult male and female rats > 2500 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The data in the present report were accumulated over a period of several years.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- In general, the methods and procedures used were the same as those used in earlier work (Gaines (1960). The acute toxicity of pesticides to rats. Toxicol. Appl. Pharmacol. 2, 88-99 and
Gaines (1969). Acute toxicity of pesticides. Toxicol. Appl. Pharmacol. 14,515-534.) - GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- technical grade
- Species:
- rat
- Strain:
- Sherman
- Remarks:
- specific-pathogen-free (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: The rat colony was rederived via cesarean section and maintained under barrier conditions by the U.S. Centers for Disease Control, Atlanta, Georgia. Animals were transferred from the barrier facility at weaning and kept in conventional quarters until used.
- Age at study initiation: Adult animals were at least 90 days of age and weanlings were 4-6 weeks of age when tested.
- Route of administration:
- oral: gavage
- Vehicle:
- other: water and oil soluble compounds were given as solutions in water or peanut oil and poorly soluble compounds were given as suspensions in peanut oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED:
Adults: Whenever possible the compounds were formulated in varying concentrations and administered in volumes of 5 mL/kg bw. Dosage volumes were routinely 5-10 mL/kg for oral dosing.
Weanlings: Dosage rates up to 20 mL/kg.
- Doses:
- Minima of 10 animals per group and 4 dosage levels were used for each LD50 calculation.
- No. of animals per sex per dose:
- Minima of 10 animals per group and 4 dosage levels were used for each LD50 calculation.
- Details on study design:
- - Duration of observation period following administration: at least 14 days dosing or until recovered from signs of toxicity.
- Statistics:
- LD50 values and related parameters were calculated using a computer based implementation of Finney’s maximum likelihood probit technique (Lieberman, 1983).
A ratio of greater than 1 indicates greater toxicity to the female compared to the male or greater toxicity to the weanling compared to the adult. The LD50 ratios are considered statistically different from 1 (p < 0.05) when the 95% confidence limits of the LD50 values do not overlap. - Sex:
- male
- Dose descriptor:
- LD50
- Remarks:
- adult
- Effect level:
- 1 226 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 970 - < 1 642
- Remarks on result:
- other: slope: 4.2
- Sex:
- female
- Dose descriptor:
- LD50
- Remarks:
- adult
- Effect level:
- 1 053 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 885 - < 1 249
- Remarks on result:
- other: slope: 4.6
- Sex:
- male
- Dose descriptor:
- LD50
- Remarks:
- weanling
- Effect level:
- 2 232 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 911 - < 2 568
- Remarks on result:
- other: slope: 5.2
- Remarks:
- LD50 ratio adult/weanling: 0.55 (p<0.05)
- Conclusions:
- Lowest oral LD50 in adult rats: ca. 1053 mg/kg bw.
- Executive summary:
LD50 values were determined for 57 pesticides (among which Monuron) administered by the oral (or dermal) route to adult male and female Sherman rats. Monuron was also tested by the oral route in one sex of weanlings (males). Many of these and earlier LD50 tests have been done in different years and in various months of the year. Since the LD50 value is influenced by variables such as species, strain, and test method, the best estimates of relative toxicity are derived from data collected in a single species and strain under identical conditions. The values for acute toxicity reported here represent the final compilation of data for the LD50 test program whose purpose was to establish a reliable data base on the relative toxicities of pesticidal chemicals in rats, and to obtain other pertinent information including the type, onset, and duration of toxic effects following a single dose.
Except as indicated the compounds were technical grade and were dissolved or suspended in peanut oil for oral dosing (stomach tube). Water and oil soluble compounds were given as solutions in water or peanut oil and poorly soluble compounds were given as suspensions in peanut oil. Whenever possible the compounds were formulated in varying concentrations and administered in volumes of 5 mL/kg body weight for oral dosing. Because of low toxicity or poor solubility of some of the compounds, it was sometimes necessary to adjust the dose volumes as indicated. Adult animals were at least 90 days of age and weanlings were 4-6 weeks of age when tested. Minima of 10 animals per group and four dosage levels were used for each LD50 calculation. The animals were observed for at least 14 days after dosing or until recovered from signs of toxicity. LD50 values and related parameters were calculated using a computer based implementation of Finney’s maximum likelihood probit technique (Lieberman, 1983).
Consistent with previous findings (Gaines, 1960, 1969) the female rat displayed a somewhat greater susceptibility to a number of the chemicals tested. The greater drug metabolizing activity of liver microsomes in the male rat probably accounts for many of the sex-related differences in toxicity which are observed in this species. As expected, nearly all of the compounds were substantially less toxic by the dermal route than by the oral route.
For Monuron female oral LD50 was 1053 mg/kg bw with 95% confidence limits from 885-1249 mg/kg bw and male oral LD50 was 1226 mg/kg bw with 95% confidence limits from 970-1642 mg/kg bw in adult rats.
A number of other studies have demonstrated that susceptibility to the toxicity of chemicals can vary with age. We found that, of 28 chemicals for which adult/weanling oral LD50 ratios were obtained, only 14% were more toxic to the weanling while 64% were more toxic to the adult. The route of exposure may he particularly important in developing animal models of age-related toxicity.
For Monuron male oral LD50 in weanling rats was 2232 mg/kg bw with 95% confidence limits from 1911-2568 mg/kg bw. The LD50 ratio Adult/Weanling was 0.55 (p < 0.05). (Gaines and Linder, 1986).
Reference
Table 1. Acute oral toxicity of Monuron in ratsa
Common name |
Ageb |
Sex |
Route |
LD50(mg/kg) |
95% CL (mg/kg) |
Slope |
LD50 (M/F) |
LD50 Ratio (A/W) |
Monuron |
A |
M |
Oral |
1226 |
970-1642 |
4.2 |
|
|
|
A |
F |
Oral |
1053 |
885-1249 |
4.6 |
1.16 |
|
|
W |
M |
Oral |
2232c |
1911-2568 |
5.2 |
|
0.55* |
a For oral dosing, water and oil soluble compounds were given as solutions in water or peanut oil and poorly soluble compounds were given as suspensions in peanut oil.
Dosage volumes were routinely 5-10 mL/kg for oral dosing. Exceptions to the above are noted.
b A = Adult; W = Weanling.
c Dosage rates up to 20 mL/kg.
* p< 0.05.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 053 ng/kg bw
- Quality of whole database:
- Reliable literature available
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- In general, the methods and procedures used were the same as those used in earlier work (Gaines (1960). The acute toxicity of pesticides to rats. Toxicol. Appl. Pharmacol. 2, 88-99 and
Gaines (1969). Acute toxicity of pesticides. Toxicol. Appl. Pharmacol. 14,515-534.) - GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- technical grade
- Species:
- rat
- Strain:
- Sherman
- Remarks:
- adult specific-pathogen-free (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: The rat colony was rederived via cesarean section and maintained under barrier conditions by the U.S. Centers for Disease Control, Atlanta, Georgia. Animals were transferred from the barrier facility at weaning and kept in conventional quarters until used
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: Adult animals were at least 90 days of age when tested. - Type of coverage:
- not specified
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the freshly shaved shoulder and back area
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):Whenever possible the compounds were administered in volumes of 1.6 mL/kg body weight for dermal dosing. Dosage volumes were routinely 1.6-10 mL/kg for dermal dosing.
- Concentration (if solution): Whenever possible the compounds were formulated in varying concentrations.
- No. of animals per sex per dose:
- Minima of 10 animals per group and four dosage levels were used for each LD50 calculation.
- Details on study design:
- - Duration of observation period following administration: The animals were observed for at least 14 days after dosing or until recovered from signs of toxicity.
- Statistics:
- LD50 values and related parameters were calculated using a computer based implementation of Finney’s maximum likelihood probit technique (Lieberman, 1983).
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Conclusions:
- Dermal LD50 for monuron was > 2500 mg/kg.
- Executive summary:
LD50 values were determined for 57 pesticides (among which Monuron) administered by the (oral or) dermal route to adult male and female Sherman rats. Many of these and earlier LD50 tests have been done in different years and in various months of the year. Since the LD50 value is influenced by variables such as species, strain, and test method, the best estimates of relative toxicity are derived from data collected in a single species and strain under identical conditions. The values for acute toxicity reported here represent the final compilation of data for the LD50 test program whose purpose was to establish a reliable data base on the relative toxicities of pesticidal chemicals in rats, and to obtain other pertinent information including the type, onset, and duration of toxic effects following a single dose.
Except as indicated the compounds were technical grade and were dissolved or suspended in xylene for dermal application to the freshly shaved shoulder and back area. Monuron was suspended in propylene glycol. Whenever possible the compounds were formulated in varying concentrations and administered in volumes of 1.6 mL/kg body weight for dermal dosing. Because of low toxicity or poor solubility of some of the compounds, it was sometimes necessary to adjust the dose volumes as indicated. Dosage volumes were routinely 1.6-10 mL/kg for dermal dosing.
Adult animals were at least 90 days of age and weanlings were 4-6 weeks of age when tested. Minima of 10 animals per group and four dosage levels were used for each LD50 calculation. The animals were observed for at least 14 days after dosing or until recovered from signs of toxicity. LD50 values and related parameters were calculated using a computer based implementation of Finney’s maximum likelihood probit technique (Lieberman, 1983).
As expected, nearly all of the compounds were substantially less toxic by the dermal route than by the oral route.
For Monuron dermal LD50 was > 2500 mg/kg bw in male and female adult rats.
Reference
Table 1. Acute dermal toxicity of Monuron in ratsa
Common name |
Ageb |
Sex |
Route |
LD50 (mg/kg) |
Monuron |
A |
M |
Dermal |
>2500c |
|
A |
F |
Dermal |
>2500c |
|
|
|
|
|
a For dermal dosing, compounds were usually dissolved in xylene.
Dosage volumes were routinely 5-10 mL/kg for oral dosing and 1.6-10 mL/kg for dermal dosing. Exceptions to the above are noted.
b A = Adult; W = Weanling.
c In propyIene glycol suspension.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- Reliable literature available
Additional information
Acute oral toxicity
Key LD50 values were determined for Monuron administered by oral gavage to adult male and female Sherman rats and in one sex of weanling rats (males). Adult animals were at least 90 days of age and weanlings were 4-6 weeks of age when tested. In adult rats, female oral LD50 was 1053 mg/kg bw with 95% confidence limits from 885-1249 mg/kg bw and male oral LD50 was 1226 mg/kg bw with 95% confidence limits from 970-1642 mg/kg bw in adult rats. In weanling rats, male oral LD50 in weanling rats was 2232 mg/kg bw with 95% confidence limits from 1911-2568 mg/kg bw (Gaines and Linder, 1986).
Supporting studies provided following oral LD50 values:
- LD50 = 1480 mg/kg bw in rats (NTP, 1988).
- LD50 = 1480-3700 mg/kg bw in rats (IARC, 1991).
- LD50 = 3600 mg/kg bw with confidence limits of 2800 to 4400 mg/kg (US EPA, 1975).
- LD50 = 1920 mg/kg in mice (NTP, 1988).
Acute inhalation toxicity
Based upon the low vapor pressure of Munuron (5.03E-07 mm Hg), acute inhalation toxicity testing was waived.
Acute dermal toxicity
A key LD50 values was determined for Monuron administered by the (dermal route to adult male and female Sherman rats. Adult animals were at least 90 days of age. For Monuron dermal LD50 was > 2500 mg/kg bw in male and female adult rats. (Gaines and Linder, 1986). Based on this value, Monuron was less toxic by the dermal route than by the oral route.
Supporting studies provided following dermal LD50 values:
- LD50 > 2500 mg/kg bw in rabbits (IARC, 1991).
- A 20% suspension of monuron in dimethyl phthalate was applied to shaved skin between the shoulders of a male rabbit. A maximum feasible dose of 2250 mg/kg was administered over an 8-hr period by rubbing it into the skin with a glass rod. Five hours after treatment, the material was caked on the rabbit' s back. The material disappeared within 2 days, and the rabbit showed no clinical signs of intoxication. No significant clinical pathology was found at sacrifice, 11 days after treatment (US EPA, 1975).
Justification for classification or non-classification
Based on these results and according to CLP (No. 1272/2008 of 16 December 2008), Monuron has a harmonised classification Category 4 (H302. Harmful if swallowed) for acute oral toxicity with signal word 'WARNING'.
Based on these results and according to CLP (No. 1272/2008 of 16 December 2008), Monuron does not have to be classified and has no obligatory labelling requirement for dermal toxicity.
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