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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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 February 1992 to 13 November 1992
- Reliability:
- 1 (reliable without restriction)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- 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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on mating procedure:
- Stated below in 'Details on Study Schedule'
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 70 days of treatment prior to mating, then through to weaning
- Frequency of treatment:
- Continuous
- Details on study schedule:
- Following ~70 days of treatment, male and females within each dose group were randomly paired and cohabitated (1:1) for up to 3 weeks to yield F1 littes of the first generation (P0). On postpartum day 4, litters were culled to 8 pups leaving where possible equal number of male and female offspring. At 21 days of age pups were weaned. 30 male and 30 females within each dose level were randomly selected from among as many F1 litters as possible and continued on treatment as the P1 animals The P0 males were necropsied at 177-180 days of age after 134-137 days of dietary treatment. After weaning of F1 pups, the P0 females were necropsied at 183-186 days of age after 140-143 days of dietary treatment.After an additional 69 days of dietary treatment (at~109 days old), P1 animals were mated as described to yield the F2 litters. P1 males were necropsied at 171-177 days of age. After weaning of F2 pups, the P1 females were necropsied at 178-185 days of age.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:0, 5, 100, 400 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:P0 Males: 0, 0.22, 4.5, 18 mg/kg dietBasis:actual ingested
- Remarks:
- Doses / Concentrations:P0 Females: 0, 0.31, 6.1, 25 mg/kg dietBasis:actual ingested
- Remarks:
- Doses / Concentrations:P1 Females: 0, 0.28, 5.5, 22 mg/kg dietBasis:actual ingested
- Remarks:
- Doses / Concentrations:P1 Males: 0, 0.21, 4.2, 17 mg/kg dietBasis:actual ingested
- No. of animals per sex per dose:
- 30 animals/sex/group
- Control animals:
- yes, plain diet
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOEL
- Remarks:
- Toxicity
- Effect level:
- ca. 100 ppm (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: (equivalent to ~7 mg/kg/day). Decreased bodyweight , bodyweight changes and food consumption at 400 ppm
- Remarks on result:
- other: Generation: Parental and pup (migrated information)
- Dose descriptor:
- NOAEL
- Remarks:
- Reproductive toxicity
- Effect level:
- ca. 400 ppm
- Sex:
- female
- Basis for effect level:
- other: (equivalent to ~35 mg/kg/day). No effects on reproductive parameters observed up to a maximum dose of 400 ppm
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 7.38 mg/kg bw/day
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- body weight and weight gain
Overall reproductive toxicity
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 29.81 mg/kg bw/day
- Treatment related:
- not specified
Any other information on results incl. tables
PARENTAL ANIMALS:
Clinical signs and mortality:
No test material related clinical signs of toxicity were observed in males or females from either generation.
Bodyweight:
Significant reductions (p<0.05 or p<0.01) were observed at the 400 ppm males P0 group throughout the study. A similar effect was observed in P1 males at the same dose.
For P0 females mean body weights were statistically lower over the gestational period. For P1 females in the 400 ppm group interval body weight change was significantly lower on day 68 (end of mating phase) and there were no differences in cumulative weight changes.
Food consumption:
For P0 males food consumption was similar for the 5 and 100 ppm groups. Mean food consumption values for the 400 ppm group were consistently below the values for the 0 ppm group throughout the study with statistically significant reductions occurring for those intervals ending on days 3, 73 and 94. Similar observations were seen in the P1 male generation
For P0 females food consumption values for the control and the 5 and 100 ppm dose levels were generally similar throughout this generation. At 400 ppm food consumption values for the 400 ppm dose level were consistently slightly lower during the pre-mating phase, with statistically significant decreases observed only for study day 0 to 3 interval. Again, similar observations were seen in the P1 female generation.
Overall mean test material consumption for both generations throughout the study was equivalent to 0.36, 7.38 and 29.81 mg/kg/day for dietary levels of 5, 100 and 400 ppm respectively.
Reproductive function and performance:
There were no treatment related effects on mating behaviour as the precoital interval was similar among all groups in both generations. For P0 evidence of mating was observed in 70, 87, 87 and 87% of the females in the 0, 5, 100 and 400 ppm dose levels respectively within the first 4 days of cohabitation. For the P1 generation evidence of mating was observed in 83, 80, 83 and 90% for females in the 0, 5, 100 and 400 ppm dose levels respectively.
Litters with liver born pups was similar across all dose groups, in both generations. Mean gestation length, mating index fertility and gestation indices were comparable among all groups, in both generations.
Parental post mortem results:
No gross necropsy observations suggestive of a relationship to treatment with CGA 15324 Technical. There were no histological lesions, either non-neoplastic or neoplastic considered to be related to dietary administration of the test material.
There were no treatment related effects on male reproductive organs.
OFFSPRING:
Bodyweight:
Mean body weight gain of F1 and F2 pups at 400 ppm were statistically reduced (p<0.05) on day 14 and 21, which coincided with the direct ingestion of diet containing test material. This onset was indicative of signs of toxicity from ingestion of test material and not a reproductive effect.
Pup survival indices
The % of total pups born alive and remaining alive on day 4 (total born viability), of live born pups on day 4 (live born viability) and of the pups after culling surviving to weaning were comparable among the control and treated groups for both F1 and F2 litters.
Offspring post mortem results:
F1 and F2 pups: There were no test material related effects on the number of preweaning losses calculated runts or external observations. No test material related macroscopic findings were observed in incidental (preweaning) deaths, day 4 culled pups or weanlings. There was no significant increase in the number of pups with malformations in the treated groups. All malformations were considered incidental.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the results of this study clearly demonstrate the absence of any adverse effects on reproductive parameters. The NOAEL for reproductive toxicity was at least 400 ppm (29.81 mg/kg/day). Based on reduced body weight gains and food consumption at 400 ppm, the NOEL for parental and pup toxicity was 100 ppm (7.38 mg/kg/day).
- Executive summary:
CGA 15324 Technical was administered in the diet to rats at concentrations of 0, 5, 100 and 400 ppm (corresponding to 0, 0.4, 7 and 35 mg/kg/day) through two generations. Administrations started 10 weeks prior to the P0 generation being paired and mated. Rats were randomly paired within dose groups to yield the F1 generation. On lactation day 4 litters were culled to four male and for females where ever possible. Culled pups underwent a soft tissue examination with the focus on the brain and heart.
F1 pups were weaned at 21 days of age. Within each dose level rats were randomly selected to continue on treatment as parent animals of the F2 generation. They underwent the same study phases as P0 animals. Adult animals were necropsied and reproductive tissues examined histologically.
At the 400 ppm dose level, reduced body weight gains and food consumption were noted in parental animals and pups of both sexes. There were no treatment related clinical signs, necropsy findings or histopathological observations at any dose level. Reproduction performance was not affected. There were no effects on mating, behaviour, gestation length, the number of litters with live born pups, the total number of pups/litter, preweaning losses, survival indices. No macroscopic findings were noted in pups.
In conclusion, the results of this study clearly demonstrate the absence of any adverse effects on reproductive parameters. The NOAEL for reproductive toxicity was at least 400 ppm (29.81 mg/kg/day). Based on reduced body weight gains and food consumption at 400 ppm, the NOEL for parental and pup toxicity was 100 ppm (7.38 mg/kg/day).
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