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EC number: 213-322-3 | CAS number: 937-14-4
- 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
The potential toxic effects of the substance when given orally by gavage for a minimum of 28 days to Wistar Han rats was determined employing the combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test.The dose levels in this study were 0, 15, 50 and 150 mg/kg/day, based on the results of the dose range finder.No parental toxicity was observed up to the highest dose level tested (150 mg/kg). A few non-adverse changes were noted at 50 and/or 150 mg/kg and consisted of slight salivation after dosing at 50 and 150 mg/kg (in a dose-related manner), regarded as a physiological response related to the irritant properties of the substance rather than a sign of systemic toxicity, and a gelatinous thyroid gland at 150 mg/kg in 2/10 females. This macroscopic finding was not associated with histopathological alterations in the thyroid gland. Based on the results of this combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the No Observed Adverse Effect Level (NOAEL) of the substance is 150 mg/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 October 2017 - 02 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- 2016
- Deviations:
- yes
- Remarks:
- None of the deviations were considered to have impacted the overall integrity of the study or the interpretation of the study results and conclusions.
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- Batch: A0378021
Purity/Composition: 98.8% of 3- Chloroperoxybenzoic acid (72%) balanced with 3- chlorobenzoic acid (8.8%) and water (18%) (Appendix 3)
Test item storage: In refrigerator (2-8°C)
Stable under storage conditions until: 31 October 2019 (retest date) - Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl: WI(Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were allowed to acclimate to the Test Facility toxicology accommodation for 7 days prior to start of the pre-test period (females) or 7 days before the commencement of dosing (males). Animals were group housed (up to 5 animals of the same sex and same dosing group together) in polycarbonate cages (Macrolon, MIV type, height 18 cm). Target temperatures of 18 to 24°C with a relative target humidity of 40 to 70% were maintained. The actual daily mean temperature during the study period was 20 to 22°C with an actual daily mean relative humidity of 43 to 49%. A 12 hour light/12 hour dark cycle was maintained, except when interrupted for designated procedures. Ten or greater air changes per hour with 100% fresh air (no air recirculation) were maintained in the animal rooms. Pelleted rodent diet and municipal tap water was provided ad libitum throughout the study, except during designated procedures.
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Duplicate sets of samples (approximately 500 mg) were sent to the analytical laboratory. Concentration results were considered acceptable if mean sample concentration results were within or equal to ± 10% for solutions of target concentration. Duplicate sets of samples (approximately 500 mg) were sent to the analytical laboratory. Homogeneity results were considered acceptable if the coefficient of variation (CV) of concentrations was =< 10%. Stability analyses performed previously in conjunction with the method development and validation study demonstrated that the substance is stable in the vehicle when prepared and stored under the same conditions at concentrations bracketing those used in the present study.
- Duration of treatment / exposure:
- Males were treated for 29 days, i.e. two weeks prior to mating, during mating and up to and including the day before scheduled necropsy. Females that delivered were treated for 50-56 days (most females) or 63 days (one control female and one female of Group 3), i.e. 14 days prior to mating (with the objective to cover at least two complete estrous cycles), the variable time to conception, the duration of pregnancy and 13 or 15 days after delivery, up to and including the day before scheduled necropsy. Females which failed to deliver were treated for 41 days.
- Frequency of treatment:
- Administration of the substance to the appropriate animals by once daily oral gavage 7 days a week for a minimum of 29 days.
- Dose / conc.:
- 15 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes, concurrent vehicle
- Observations and examinations performed and frequency:
- Throughout the study, animals were observed for general health/mortality and moribundity twice daily.
Clinical observations were performed at least twice daily.
Clinical observations were conducted in a standard arena beginning before the first administration of the test item and then once weekly throughout treatment. These observations were conducted 3 hours post-dose.
Animals were weighed individually on the first day of treatment (prior to dosing), and weekly thereafter.
Food consumption was quantitatively measured weekly, except for males and females which were housed together for mating and for females without evidence of mating.
Functional tests (hearing ability, pupillary reflex, static righting reflex, locomotor activity and fore- and hind-limb grip strength) were performed on the selected 5 males during Week 4 of treatment and the selected 5 females during the last week of lactation (i.e. PND 6-13). These tests were performed 3 hours post-dose, after completion of clinical observations. - Sacrifice and pathology:
- Animals surviving until scheduled euthanasia were weighed, and deeply anaesthetized using isoflurane and subsequently exsanguinated and subjected to a full post mortem examination.
- Statistics:
- All statistical tests were conducted at the 5% significance level. All pairwise comparisons were conducted using two sided tests and were reported at the 5% levels.
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No substance-related clinical signs of toxicity were noted during daily clinical observations or during weekly arena observations.
Salivation was noted at 150 mg/kg in all animals on most days of the study and, less frequently, at 50 mg/kg. This salivation was considered to be a physiological response rather than a sign of systemic toxicity considering its slight severity and the time of occurrence (i.e. immediately after dosing), and may be related to the irritancy of the test item. The salivation observed on a few occasions at 15 mg/kg was regarded as a background finding as salivation occurred with comparable frequency in concurrent controls. Any other clinical signs noted incidentally occurred within the range of background findings to be expected for rats of this age and strain which are housed and treated under the conditions in this study and showed no dose-related trend. At the incidence observed, these were considered to be unrelated to treatment. - Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- No mortality occurred during the study period that was considered to be substance-related.
Female no. 68 (Group 3) died after blood sampling on the scheduled day of necropsy. Her death was considered to be related to the blood sampling procedure under anesthesia and regarded as unrelated to the treatment with the substance. - Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no changes in body weights or body weight gain that were considered to be toxicologically relevant.
In males at 150 mg/kg, mean body weight gain over the 4-week treatment period was lower than that in controls, resulting in a 6% lower mean body weight at the end of the study. This change was considered not to be toxicologically relevant based on its slight magnitude and lack of statistical significance. - Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food consumption (before and after correction for body weight) was considered not to be affected by treatment.
Compared to controls, mean food consumption values (absolute and relative to body weight) of females at 150 mg/kg were about 10% higher throughout the lactation period. The differences were not statistically significant and food consumption of individual 150 mg/kg females generally remained within the concurrent control range. It was noted that one control female (no. 45) with a small litter consumed markedly less food than the other females, which lowered mean food consumption values for the control group. For these reasons, the higher food consumption values at 150 mg/kg were considered not to represent an effect of the substance.
An isolated, statistically significant difference noted in females at 50 mg/kg (higher food consumption between post-coitum Days 4-7) was regarded as a chance finding unrelated to treatment. - Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Treatment up to 150 mg/kg was not associated with changes in red blood cell parameters, white blood cell parameters or number of platelets.
An isolated, statistically significant difference noted in males (lower number of platelets at 50 mg/kg) was considered to be unrelated to treatment due to the lack of a dose-related trend. - Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment-related changes in clinical chemistry parameters.
An isolated, statistically significant difference noted in females (higher sodium at 15 mg/kg) was not attributed to treatment due to the lack of a dose-related trend.
The higher mean plasma concentration of inorganic phosphate noted in females at 150 mg/kg was regarded as unrelated to treatment as the difference from controls was not statistically significant and values in 150 mg/kg females remained within the historical control range (mean inorganic phosphate at 150 mg/kg was close to the historical control mean). - Urinalysis findings:
- not examined
- Behaviour (functional findings):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Functional observation parameters were considered not to be affected by treatment.
Values for females at 15 mg/kg were lower (not statistically significant) compared to the other groups. In the absence of a dose response, this finding was not considered treatment related. - Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no substance-related alterations in organ weights.
An isolated, statistically significant difference noted in females (lower relative brain weight at 50 mg/kg) was not attributed to treatment due to the lack of a dose-related trend. - Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At necropsy, two females treated at 150 mg/kg (nos. 75 and 77) showed a gelatinous thyroid gland. It could not be excluded that this finding was related to treatment as it was noted for 2/10 females at the highest dose level at an incidence above background. There was no microscopic correlate for this macroscopic change.
The remainder of the recorded macroscopic findings were within the range of background gross observations encountered in rats of this age and strain. These findings were therefore considered to be unrelated to treatment. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: all examined endpoints.
- Critical effects observed:
- no
- Conclusions:
- Based on the results of this combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the No Observed Adverse Effect Level (NOAEL) of 3- Chloroperoxybenzoic Acid is 150 mg/kg bw/day.
- Executive summary:
The potential toxic effects of 3-Chloroperoxy-benzoic Acid when given orally by gavage for a minimum of 28 days to Wistar Han rats was determined employing the combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test. The potential to affect male and female reproductive performance such as gonadal function, mating behavior, conception, parturition and early postnatal development was also evaluated in this study. The dose levels in this study were 0, 15, 50 and 150 mg/kg/day, based on the results of the dose range finder. No parental toxicity was observed up to the highest dose level tested (150 mg/kg). A few non-adverse changes were noted at 50 and/or 150 mg/kg and consisted of slight salivation after dosing at 50 and 150 mg/kg (in a dose-related manner), regarded as a physiological response related to the irritant properties of the substance rather than a sign of systemic toxicity, and a gelatinous thyroid gland at 150 mg/kg in 2/10 females. This macroscopic finding was not associated with histopathological alterations in the thyroid gland. Based on the results of this combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the No Observed Adverse Effect Level (NOAEL) of 3- Chloroperoxybenzoic Acid is 150 mg/kg bw/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Sufficient to meet requirements.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the findings of a reliable combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test
conducted on the substance, classification of the substance is not justified.Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.