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EC number: 200-431-6 | CAS number: 59-50-7
- 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
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Toxicity of chlorocresol was assessed in pregnant female in 10 days study
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous methyl cellulose
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Justification for use and choice of vehicle (if other than water): no data
- Concentration in vehicle: 0, 30, 100, or 300 mg/kg
- Amount of vehicle (if gavage): 0.5%
- Lot/batch no. (if required): no data
- Purity: no data - Details on mating procedure:
- Pregnant females were used
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Days 6–15 of gestation
- Frequency of treatment:
- Once daily
- Remarks:
- Doses / Concentrations:
0, 30, 100, or 300 mg/kg
Basis:
nominal conc. - No. of animals per sex per dose:
- 25 female rats
- Control animals:
- yes
- Parental animals: Observations and examinations:
- Clinical examinations were performed daily, food and water intake were noted and body weights were recorded on gestation days (GD) 0, 6–15, and 20.
- Oestrous cyclicity (parental animals):
- no data
- Sperm parameters (parental animals):
- no data
- Litter observations:
- Uterine and fetal weights were recorded
- Postmortem examinations (parental animals):
- Gross pathological examinations were performed on GD 20, at which time uteri were removed and examined for numbers of corpora lutea, implantations, live fetuses, and live fetuses per sex.
- Postmortem examinations (offspring):
- Fetuses were examined for signs of external malformations. Half of the fetuses were examined for gross and skeletal malformations; the other half were prepared for visceral examination.
- Statistics:
- no data
- Reproductive indices:
- no data
- Offspring viability indices:
- no data
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- not examined
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- effects observed, treatment-related
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: labored breathing and decreased body weight
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: labored breathing and decreased body weight
- Critical effects observed:
- not specified
- Clinical signs:
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Remarks on result:
- not measured/tested
- Critical effects observed:
- not specified
- Reproductive effects observed:
- not specified
- Conclusions:
- The maternal NOAEL and LOAEL (labored breathing and decreased body weight) for the study are 30 and 100 mg/kg-day, respectively
- Executive summary:
Groups of 25 pregnant Wistar rats were given 0, 30, 100, or 300 mg/kg of Preventol CMK (p-chloro-m-cresol) by gavage in 0.5% aqueous methyl cellulose, once per day on Days 6–15 of gestation. Clinical examinations were performed daily, food and water intake were noted and body weights were recorded .Gross pathological examinations were performed on GD 20, at which time uteri were removed and examined for numbers of corpora lutea, implantations, live fetuses, and live fetuses per sex. Uterine and fetal weights were recorded and fetuses were examined for signs of external malformations. Half of the fetuses were examined for gross and skeletal malformations; the other half were prepared for visceral examination. Clinical signs of toxicity, including prostration, convulsions and labored breathing, were observed in high-dose dams. Decrease in body weight, food intake and water consumption was observed in high dose dams. No significant treatment-related effects were found for number of corpora lutea, implantations, live fetuses, and live fetuses per sex in any of the dose groups. Pathological findings in these dams included gas-filled intestines and vaginal bleeding. Hence, the maternal NOAEL and LOAEL was considered to be 30 and 100 mg/kg-day, respectively.
Reference
Clinical signs of toxicity, including prostration and convulsions, were observed in high-dose dams on Day 6 of gestation. From GD 8 onward, clinical signs of toxicity became increasingly apparent and included labored breathing and bloody nasal exudate.
Between GD 12 and 18, five of the high-dose dams died and another was sacrificed after being found in a moribund state.
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
Mean maternal body-weight gain in high-dose dams was decreased by 96%, relative to controls
Food intake in the high-dose dams was significantly lower than that of controls throughout the treatment period
Decreased water intake was also noted in high-dose dams
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
No significant treatment-related effects were found for number of corpora lutea, implantations, live fetuses, and live fetuses per sex in any of the dose groups
GROSS PATHOLOGY (PARENTAL ANIMALS)
Preliminary pathological findings in these dams included gas-filled intestines and vaginal bleeding in 3/6
significantly decreased mean fetal weight was observed
SEXUAL MATURATION (OFFSPRING)
Signs of fetotoxicity were observed only in the high-dose group and included significantly increased early resorptions (a mean of 1.8/dam in the high-dose group compared with 0.6/dam in controls)
OTHER FINDINGS (OFFSPRING)
There was a significant skewing of the normal sex ratio from 55.6% males to 45.6% males at the Mid-dose.
There were no treatment-related fetal malformations at any dose level
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 30 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Toxicity to Reproduction:
Based on the various studies available with Klimish rating 2 & 4 for target CAS NO 59-50-7 based on the category approach of organic functional group along with similar mechanistic approach and having structural similarities defined by QSAR toolbox. This data is combined with the prediction done using the QSAR toolbox for the target chemical based on similar category approach, the results is summarized as follows
Sr. No |
End point |
Value |
Species |
Effects |
Remarks |
1 |
NOAEL (Maternal)
LOAEL
|
30 mg/Kg bw /d
100 mg/Kg bw /d |
Rat |
labored breathing and decreased body weight |
Data from publication for target chemical
|
2 |
ERBA
|
0.00042 |
rat uterine cytosol. |
binding affinity is less to cause any damage in uterine tissue |
Data from publication for target chemical
|
3 |
NOAEL (Maternal)
|
428 mg/Kg bw /d
|
Rat |
No reproductive parameters were affected in either of the two generations.
|
Predicted data for target chemical |
Based on the studies summarized in the above table it can be observed that NOAEL values was found to be in the range of 30 -428 mg/Kg bw/ d and LOAEL was found to be 100 mg/kg bw/day and the ERBA value was found to be 0.00042 based on the data from prediction for target as well as publication. The effects observed on these doses was listed as follows
· labored breathing and decreased body weight.
· binding affinity is less to cause any damage in uterine tissue
· No reproductive parameters were affected in either of the two generations
Thus based on above values it can be concluded that substance CAS NO 59-50-7 is expected to show the similar toxicological effect based on the effects observed on the other category members. Since the no effective dose value (NOAEL) is 30 mg/Kg bw/d thus based on this value it can be concluded that substance CAS NO 59-50-7 is considered to be not toxic to reproduction below this dose level .Also CAS NO 59-50-7 does not indicates any mechanistic trigger towards the toxicity to reproduction based on absence of noncyclic structure that would raise concern of CAS NO 59-50-7 on toxicity to human reproduction. Thus CAS NO 59-50-7 is considered to be not toxic to reproductive effects for the above mentioned dose levels.
Justification for selection of Effect on fertility via oral route:
Groups of 25 pregnant Wistar rats were given 0, 30, 100, or 300 mg/kg of Preventol CMK (p-chloro-m-cresol) by gavage in 0.5% aqueous methyl cellulose, once per day on Days 6–15 of gestation. Clinical examinations were performed daily, food and water intake were noted and body weights were recorded .Gross pathological examinations were performed on GD 20, at which time uteri were removed and examined for numbers of corpora lutea, implantations, live fetuses, and live fetuses per sex. Uterine and fetal weights were recorded and fetuses were examined for signs of external malformations. Half of the fetuses were examined for gross and skeletal malformations; the other half were prepared for visceral examination. Clinical signs of toxicity, including prostration, convulsions and labored breathing, were observed in high-dose dams. Decrease in body weight, food intake and water consumption was observed in high dose dams. No significant treatment-related effects were found for number of corpora lutea, implantations, live fetuses, and live fetuses per sex in any of the dose groups. Pathological findings in these dams included gas-filled intestines and vaginal bleeding. Hence, the maternal NOAEL and LOAEL was considered to be 30 and 100 mg/kg-day, respectively.
Effects on developmental toxicity
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Toxicity of chlorocresol was assessed in pregnant female in 10 days study
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous methyl cellulose
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Justification for use and choice of vehicle (if other than water): no data
- Concentration in vehicle: 0, 30, 100, or 300 mg/kg
- Amount of vehicle (if gavage): 0.5%
- Lot/batch no. (if required): no data
- Purity: no data - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Pregnant females were used
- Duration of treatment / exposure:
- Days 6–15 of gestation
- Frequency of treatment:
- Once daily
- Duration of test:
- 10 days
- Remarks:
- Doses / Concentrations:
0, 30, 100, or 300 mg/kg
Basis:
nominal conc. - No. of animals per sex per dose:
- 25 female rats
- Control animals:
- yes
- Maternal examinations:
- Clinical examinations were performed daily, food and water intake were noted and body weights were recorded on gestation days (GD) 0, 6–15, and 20.
- Ovaries and uterine content:
- Gross pathological examinations were performed on GD 20, at which time uteri were removed and examined for numbers of corpora lutea, implantations, live fetuses, and live fetuses per sex.
- Fetal examinations:
- Uterine and fetal weights were recorded.
Fetuses were examined for signs of external malformations. Half of the fetuses were examined for gross and skeletal malformations; the other half were prepared for visceral examination - Statistics:
- no data
- Indices:
- no data
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Clinical signs of toxicity, including prostration and convulsions, were observed in high-dose dams on Day 6 of gestation. From GD 8 onward, clinical signs of toxicity became increasingly apparent and included labored breathing and bloody nasal exudate.
Between GD 12 and 18, five of the high-dose dams died and another was sacrificed after being found in a moribund state.
Decrease in body weight, food intake and water consumption was observed in high dose dams. No significant treatment-related effects were found for number of corpora lutea, implantations, live fetuses, and live fetuses per sex in any of the dose groups. Pathological findings in these dams included gas-filled intestines and vaginal bleeding. - Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Abnormalities:
- not specified
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Significantly decreased mean fetal weight was observed. Signs of fetotoxicity were observed only in the high-dose group and included significantly increased early resorptions (a mean of 1.8/dam in the high-dose group compared with 0.6/dam in controls). There was a significant skewing of the normal sex ratio from 55.6% males to 45.6% males at the Mid-dose. There were no treatment-related fetal malformations at any dose level - Remarks on result:
- not measured/tested
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- The developmental NOAEL and LOAEL (changes in sex ratio) for the study are 30 and 100 mg/kg-day, respectively
- Executive summary:
Groups of 25 pregnant Wistar rats were given 0, 30, 100, or 300 mg/kg of Preventol CMK (p-chloro-m-cresol) by gavage in 0.5% aqueous methyl cellulose, once per day on Days 6–15 of gestation. Uterine and fetal weights were recorded and fetuses were examined for signs of external malformations. Half of the fetuses were examined for gross and skeletal malformations; the other half were prepared for visceral examination. Significantly decreased mean fetal weight was observed. Signs of fetotoxicity were observed only in the high-dose group and included significantly increased early resorptions (a mean of 1.8/dam in the high-dose group compared with 0.6/dam in controls). There was a significant skewing of the normal sex ratio from 55.6% males to 45.6% males at the mid-dose. There were no treatment-related fetal malformations at any dose level. Hence, the Developmental NOAEL and LOAEL was considered to be 30 and 100 mg/kg-day, respectively.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 30 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Based on the various studies available with Klimish rating 2 and 4 for the target substances CAS NO 59-50-7based on the category approach of organic functional group along with similar mechanistic approach and having structural similarities defined by QSAR toolbox. This data is combined with the prediction done using the QSAR toolbox for the target chemical based on similar category approach, the results is summarized as follows
Sr. No |
End point |
Value |
Species |
Route |
Effects |
Remarks |
1 |
NOAEL (developmental)
LOAEL (developmental) |
30 mg/ kg bw/ d
100 mg/ kg bw/ d |
Rat |
Oral |
changes in sex ratio
changes in sex ratio |
Data from Study report for target chemical |
2 |
NOAEL (Embryotoxicity)
LOAEL (Embryotoxicity)
|
40 mg/l
80 mg/l |
Xenopus laevis. |
N/A |
No Mortality observed
Mortality and malformed embryos observed
|
Data from publication for target chemical |
3 |
LC50
LC10 |
13 mg/l
6 mg/l |
Xenopus laevis. |
N/A |
Mortality and malformation
|
Data from publication for target chemical
|
4 |
NOAEL (developmental)
|
47.66 mg/ kg bw/ d
|
Rat |
Oral |
clinical signs of toxicity including hypoactivity, ataxia, tremors, twitches, prone positioning, audible respiration and perioral wetness, statistically signifcant reduction in periodic maternal body weights and weight gain during the dosing period |
Predicted data of target chemical |
Based on the studies summarized in the above table with oral routes it can be observed that a NOAEL value varies from 30 mg/Kg bw/ d – 47.66 mg/l and the LOAEL values varies from 80 mg/l to 100 mg/Kg bw/ d. the LC50 and LC10 values was found to bee 16 mg/l and 6 mg/l respectively. The effects observed on these doses was listed as follows
· changes in sex ratio.
· Mortality and malformed embryos observed
· Mortality and malformation
Thus based on above discussion it can be concluded that substance CAS NO 59-50-7 is expected to show the similar toxicological effect. Since the no effective dose value (NOAEL) is 30 mg/Kg bw/d thus based on this value it can be concluded that substance CAS NO 59-50-7 is considered to be non toxic to developmental effects for the above mentioned dose. Also CAS NO 59-50-7 does not indicates any mechanistic trigger towards the toxicity based on absence of noncyclic structure that would raise concern of CAS NO 59-50-7 on toxicity to human reproduction & developmental effects. Thus CAS NO 59-50-7 is considered to be not toxic to reproductive & developmental effects for the above mentioned dose levels.
Justification for selection of Effect on developmental toxicity: via oral route:
Groups of 25 pregnant Wistar rats were given 0, 30, 100, or 300 mg/kg of Preventol CMK (p-chloro-m-cresol) by gavage in 0.5% aqueous methyl cellulose, once per day on Days 6–15 of gestation. Uterine and fetal weights were recorded and fetuses were examined for signs of external malformations. Half of the fetuses were examined for gross and skeletal malformations; the other half were prepared for visceral examination. Significantly decreased mean fetal weight was observed. Signs of fetotoxicity were observed only in the high-dose group and included significantly increased early resorptions (a mean of 1.8/dam in the high-dose group compared with 0.6/dam in controls). There was a significant skewing of the normal sex ratio from 55.6% males to 45.6% males at the mid-dose. There were no treatment-related fetal malformations at any dose level. Hence, the Developmental NOAEL and LOAEL was considered to be 30 and 100 mg/kg-day, respectively.
Justification for classification or non-classification
The substance, chlorocresol do not show any hazard effect in develpmental or reproductive stage and so cannot be considered for calssification.
Additional information
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