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EC number: 255-255-2 | CAS number: 41198-08-7
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic 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
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 452 (Chronic Toxicity Studies)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
- EC Number:
- 255-255-2
- EC Name:
- O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
- Cas Number:
- 41198-08-7
- Molecular formula:
- C11H15BrClO3PS
- IUPAC Name:
- 4-bromo-2-chlorophenyl ethyl (propylsulfanyl)phosphonate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: capsule
- Vehicle:
- other: lactose
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 12 months (once daily, 7 days/week)
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 0.015, 0.05, 1, 12.5 mg/kg/dayBasis:other:
- No. of animals per sex per dose:
- 4 animals/sex/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- ca. 12.5 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: The NOAEL for brain cholinesterase was deemed to be inexcess of 12.5 mg/kg, as no effect on enzyme activity or accompanying neutoroxic signs of toxicity were evident.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
OBSERVATIONS:
Clinical signs of toxicity:
No test material related clinical signs of toxicity were observed.
Mortality:
No mortality observed.
Auditory examination:
No auditory impairment
Bodyweight and bodyweight gain:
No test material related effects observed
Food consumption
No test material related effects observed
Eye examinations (+tonometry):
No test material related effects observed
Neurological examinations:
No test material related effects observed
Blood ands urinalysis:
Haematological findings:
Slightly decreased red blood cell parameters (erthrocyte count, haemoglobin concentration, haemocrit) were observed, however these were not thought to be of biological significance as they were either not dose related or only occured in one gender.
Clinical chemistry findings:
Throughout the study a dose related inhibition of plasma cholinesterase was recorded for males and females at all dose levels. As this was the butyryl form this was not considered biologically releant in light of the guidelines from JMPR (2007). Erythrocyte cholinesterase inhibition was seen for males and females at levels of 1 mg/kg and greater, however as brain cholinesterase activity was also measure, this was seen as the more relevant biomarker. No inhbition in this enzyme or neurotoxic estrase levels were affected by treatment. Therefore the NOAEL for brain cholinesterase was considered to be >12.5 mg/kg/day (refer to Table 7.5.1 -1).
Urinalysis:
There were no test material-related effects on urinalysis parameters.
SACRIFICE AND PATHOLOGY:
Organ weight:
No differences observed
Gross and histopathology:
No treatment related organ or tissue changes were noted at necropsy in any of the treated animals. An increased incidence of binucleated hepatocytes in the perilobular region was observed in 3/4 males and 4/4 females in the mid dose (1 mg/kg) group and all animals in the high dose group (12.5 mg/kg). The degree of change was minimal in the mid dose group and slight to moderate in the high dose group. In addition, 1/4 male dogs from the mid dose and 2/4 male dogs from the high dose group exhibited minimal to slight hyperplasia of the bile duct epithelium. As cell degeneration was not increased in these animals the toxicological significance of binucleated perilobular hepatocytes was not known.
Neurotoxicological evaluation
No difference between animals in the control group and compared to animals in the 500 ppm group were found following examination of the central and peripheral neural responses.
Table 7.5.1 -1: AChE %inhibition
Dose |
Time |
Plasma |
RBC |
Brain |
|||||||||
(ppm) |
(weeks) |
Male |
Sig |
Female |
Sig |
Male |
Sig |
Female |
Sig |
Male |
Sig |
Female |
Sig |
0 |
-1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
0 |
6 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
0 |
13 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
0 |
26 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
0 |
52 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
0.015 |
-1 |
13 |
-4 |
NS |
-34 |
6 |
NS |
- |
- |
- |
- |
||
0.015 |
6 |
55 |
* |
42 |
* |
- |
- |
- |
- |
- |
- |
- |
- |
0.015 |
13 |
55 |
* |
41 |
* |
-20 |
NS |
6 |
NS |
- |
- |
- |
- |
0.015 |
26 |
54 |
* |
35 |
* |
-24 |
NS |
8 |
NS |
- |
- |
- |
- |
0.015 |
52 |
26 |
NS |
13 |
NS |
-21 |
NS |
10 |
NS |
-15 |
NS |
-9 |
NS |
0.05 |
-1 |
-10 |
NS |
0 |
NS |
-24 |
NS |
6 |
NS |
- |
- |
- |
- |
0.05 |
6 |
62 |
* |
68 |
* |
- |
- |
- |
- |
- |
- |
- |
- |
0.05 |
13 |
63 |
* |
68 |
* |
-14 |
NS |
20 |
NS |
- |
- |
- |
- |
0.05 |
26 |
63 |
* |
67 |
* |
-11 |
NS |
30 |
NS |
- |
- |
- |
- |
0.05 |
52 |
35 |
* |
47 |
* |
-10 |
NS |
20 |
NS |
-10 |
NS |
-18 |
NS |
1 |
-1 |
16 |
NS |
10 |
NS |
-35 |
NS |
-24 |
NS |
- |
- |
- |
- |
1 |
6 |
89 |
* |
82 |
* |
- |
- |
- |
- |
- |
- |
- |
- |
1 |
13 |
88 |
* |
80 |
* |
58 |
* |
57 |
* |
- |
- |
- |
- |
1 |
26 |
91 |
* |
83 |
* |
63 |
* |
50 |
* |
- |
- |
- |
- |
1 |
52 |
82 |
* |
74 |
* |
57 |
* |
56 |
* |
-20 |
NS |
-19 |
NS |
12.5 |
-1 |
4 |
NS |
9 |
NS |
-27 |
NS |
3 |
NS |
- |
- |
- |
- |
12.5 |
6 |
93 |
* |
92 |
* |
- |
- |
- |
- |
- |
- |
- |
- |
12.5 |
13 |
92 |
* |
92 |
* |
81 |
* |
88 |
* |
- |
- |
- |
- |
12.5 |
26 |
92 |
* |
94 |
* |
82 |
* |
85 |
* |
- |
- |
- |
- |
12.5 |
52 |
88 |
* |
87 |
* |
83 |
* |
86 |
* |
11 |
NS |
6 |
NS |
Reference:
JMPR (2007). Pesticide residues in food. Joint FAO/WHO meeting on pesticide residues. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group on Pesticide Residues. Geneva, Switzerland, 18 -27 September 2007.
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for brain cholinesterase was deemed to be inexcess of 12.5 mg/kg, as no effect on enzyme activity or accompanying neutoroxic signs of toxicity were evident. In terms of general toxicological NOAEL this was considered to be 0.05 mg/kg based on haematological and blood chemistry changes and histopathological findings in the liver.
- Executive summary:
This study was conducted to assess the potential toxicity and to estimate the nOEL following exposure to CGA 15324 tech. administered in gelatin capsules to Beagle dogs. The test material was mixed with lactose and administered via capsule at daily doses of 0, 0.015, 0.05, 1 and 12.5 mg/kg/day to 4 animals/sex/gp for a period of at least 52 weeks.
No treatment related deaths wre observed in the study. In life observations and food consumption were not affected by treatment. Eye examination, intraocular pressure, neurological examination, urine analysis, organ weights and macroscopical examinations revealed no treatment realated changes. There was a slight treatment related depression in mean overal body weight gainin females in the high dose group, which was due to one female.
Erythrocyte count, haemoglobin concentration and haemocrit were reduced in males and females in the high dose group (12.5 mg/kg) and males treated at 1 mg/kg. A higher RBC volume was recorded for males at 12.5 mg/kg. In addition, at weeks 26 and 52 a slightly higher platelet count was recorded for males at >1mg/kg. Mean plasma protein and albumin levels were reduced in males and females dosed at 12.5 mg/kg and in males dosed at 1 mg/kg, mean globulin was lower in high dose females with the albumin:globulin ratio lower in males dosed at 1 and 12.5 mg/kg. This was considered to be the calcium binding properties of albumin. These effects were not considered biologically relevant as they were either not dose related or did not occur in the corresponding gender. Throughout the study a dose related inhibition of plasma cholinesterase was recorded for males and females at all dose levels tested, whereas a toxicological relevant inhibition of erythrocyte cholinesterase wa seen for males and females at >1mg/kg. Brain and cholinesterase and neurotoxic esterase levels were not affected.
On microsocpical examination, binucleated perilobular hepatocytes were increased in male and female groups (1 and 12.5 mg/kg) and were accompanied by hyperplasia of the bile duct epithelium in the male groups. In addition, bile pigments were increased in the convoluted renal tubules in high dose animals.
The NOAEL for brain cholinesterase was deemed to be inexcess of 12.5 mg/kg, as no effect on enzyme activity or accompanying neutoroxic signs of toxicity were evident. In terms of general toxicological NOAEL this was considered to be 0.05 mg/kg based on haematological and blood chemistry changes and histopathological findings in the liver.
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