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EC number: 204-593-9 | CAS number: 123-03-5
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 1979-October 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Similar to an OECD guideline study, but providing less data on findings. Performed according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- Cetylpyridinium chloride
- EC Number:
- 204-593-9
- EC Name:
- Cetylpyridinium chloride
- Cas Number:
- 123-03-5
- Molecular formula:
- C21H38N.Cl
- IUPAC Name:
- cetylpyridinium chloride
- Reference substance name:
- CPC
- IUPAC Name:
- CPC
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test Item: Cetylpyridinium Chloride
Data on file with owner company.
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- One-hundred sixteen sexually mature, virgin New Zealand SPF does and sixteen bucks were received from Charles River Breeding Laboratories, Wilmington, MA. Mass. Rabbits were weighed, ear-tagged, examined, and put in individual stainless steel cages. Does were housed in two rooms and bucks in a third. Rabbits were fed Purina Rabbit Chow and tap water ad libitum. Temperatures were from 20-25 degrees C with 45-55% humidity.. Lighting was controlled at 12 hours light and 12 hours dark, and ventilation underwent 10-15 fresh air changes per hour. The does were maintained for at least 18 days to allow any pseudo-pregnant does to become sexually receptive.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Dosing solutions were prepared daily with distilled water, and the concentrations of the test materials were calculated ont he basis of each animal receiving 2 ml of test solution per kg bw.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- not provided; on file with owner company
- Details on mating procedure:
- Due to a delay in characterizing the test material, dams were maintained for 65 days prior to breeding; the health of the animals was assessed and 6 does were excluded. The selected does were weighed and distributed into 7 groups of 15 does according to body weights. Bucks were trained to accept an artificial vagina. The use of sperm was distributed as evenly as possible among the groups of does in order to minimize genetic variability. The day of insemination was considered day 0 of gestation.
- Duration of treatment / exposure:
- Exposure and treatments lasted for a gestation period of day 7-18. However, some does were discontinued due to death or abortion of fetuses. The does were sacrificed on Day 29 of gestation.
- Frequency of treatment:
- once daily
- Duration of test:
- Days 7-18 of gestation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Groups 1-4, CPC only: 0, 2.5, 12, 100 mg/kg bw. Due to lethality, this was reduced to 25 mg/kg bw. Groups 5-7, CPC with DB: 2.5/0.28, 12/1.33, 100/11.8, reduced to 25/2.8.
Basis:
actual ingested
- No. of animals per sex per dose:
- 15 females per dose
- Control animals:
- yes, plain diet
- Details on study design:
- Doses:
Group 1: 2 ml/kg distilled water (control group)
Group 2: 2.5 mg/kg CPC
Group 3: 12.0 mg/kg CPC
Group 4 100.0 mg/kg CPC
Group 5 2.5 mg/kg CPC + 0.28 mg/kg DB
Group 6 12.0 mg/kg CPC + 1.33 mg/kg DB
Group 7: 100.0 mg/kg CPC + 11.08 mg/kg DB
The day of insemination was considered Day 0 of gestation. Beginning on the day of insemination, the amount of feed consumed was recorded and the does were weighed every 3 days, and adjustments to the dose made. Beginning on day 7 and though day 18 of pregnanacy, except where the does died early, the does were given the daily treatments by gavage. Animals were sacrificed on day 29 of gestation.
Examinations
- Maternal examinations:
- The abdomen and thorax were opened and grossly examined. Histopathologic examinations occurred in animals which died during the dosing period.
- Ovaries and uterine content:
- Uterine horns were excised and the numbers and positions of live or dead fetuses and any resorption sites were noted and recorded.
- Fetal examinations:
- Fetuses were blotted dry of amniotic fluid, examined for gross abnormalities and weighed. The dead and aborted feuses that were not macerated were included in the gross examination and examined for soft-tissue abnormalities. All kits were tagged, identifying their number, the dam number, group and study numbers.
One-third of fetuses were selected to be eviscarated, cleared in alcoholic KOH and the skeletons stained with Alitarin Red Stain. They were examined for skeletal abnormalities. The remaining two-thirds were fixed in Bouins solution for 2-4 weeks, razor-blade sectioned and examined for soft-tissue abnormalities. - Statistics:
- Mean +/- standard deviation. Standard methods as per Snedecor G and Cochran WG, 1967, Statistical Method, 6th Ed., Iowa State University Press, Ames, Iowa.
- Indices:
- not specifically presented. The number of corpora lutea were recorded.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Post mortem examinations of the dams which died after receiving 100 mg/kg bw/d indicated that the probable cause of death was from a severe disturbance of the gastrointestinal tract by the test materials, marked by severe diarrhea and gastric ulceration. Significantly decreased food consumption was produced in animals receiving 12 or 25 mg/kg bw; but there was no significant change in body weight in the 12 mg/kg bw group. Animals in the group given 25 mg/kg bw/d lost weight; those in the group receiving 25 mg CPC + 2.8 mg/kg DB gained very little weight. There were no statistically signifiant differences in the maternal weight gains during pregnancy.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 12 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Six does aborted fetuses: one in the 2.5 mg/kg CPC group, two in the 12 mg/kg CPC group, two in the 25.0 mg/kg CPC group, and one in the 25.0 CPC + 2.8 DB mg/kg group.
There were no statistical differences with regard to the average numbers of corpora lutea or average numbers of resorptions, although the number of resorptions in the high dose group (25.0 mg/kg bw CPC) was higher than in that of controls.
There was a statistically significant decrease in the number of live fetuses in the group given 25.0 CPC + 2.8 mg/kg DB. While decreased, this was not significant in the group receiving 25.0 mg/kg CPC. The effect in the 25.0 CPC + 2.8 mg/kg DB group was related to the low number of implants.
Fetal weights in the 25.0 mg/kg CPC group were significantly lower in female fetuses compared to controls, but not among males. There were no statistical differences in the average number of either male or female fetus.
Statistical examination of the fetal abnormalities found during soft-tissue sectioning demonstrated no significant differences between the control and the CPC or CPC:DB treated groups. There were no statistical increases in the overall or individual incidences of skeletal abnormalities when compared to the control.
Two dams which survived after receiving 100 mg/kg CPC, and two dams surviving after receiving 100 mg/kg CPC + 2.8 mg/kg DB, had 19 or 18 fetuses (respectively) which were normal.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 25 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
The full cohort of 15 dams in the high dose group did not receive 25 mg/kg bw/d; only 6 dams among the 15 which had not yet been treated with the test material. Therefore, the statistical power of the conclusion, at the high dose, is weaker than at lower doses.
Applicant's summary and conclusion
- Conclusions:
- CPC was examined in a teratology study in rabbits during gestation days 7-18, at doses of 2.5 to 100 mg/kg CPC, and in combination (9:1) with beta-phenoxyethyldimethyldodecyl ammonium bromide (DB). For CPC only, lethality was observed at the high dose of 100 mg/kg CPC. Of 6 rabbits not yet dosed from among the group of 15, the high dose was reduced to 25 mg/kg CPC. Maternal toxicity, as anorexia, loss of body weight and reduced food consumption, were observed at 12 and 25 mg/kg CPC. There was no teratogenic effects seen at any of the CPC levels tested. CPC is not teratogenic in rabbits at doses ranging up to ones that are embryotoxic and fatal to the dam.
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