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EC number: 234-217-9 | CAS number: 10599-90-3
- 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:
- toxicity to reproduction
- Remarks:
- other: reproductive study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study reported here was designed to evaluate reproductive effects in rats. Males were treated for 56 days and females for 14 days prior to breeding and throughout the 10-day breeding period. Females were treated throughout gestation and lactation. Following breeding, the males were necropsied and evaluated for sperm parameters and reproductive tract histopathology. Adult females and some pups were necropsied at weaning on postnatal day 21. Other pups were treated postweaning until 28 or 40 days of age. These pups were evaluated for the day of vaginal potency and thyroid hormone levels.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- Long-Evans
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories (Portage, MI)
- Age at study initiation: 4-6 weeks
- Housing: 2 per cage in polycarbonate cages
- Diet : Purina Certified Roden Chow 5002, ad libitum.
- Water : deionized water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 69-75°F
- Humidity (%): 40-60
- Photoperiod : 12 hrs dark/12 hrs light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Twelve males rats per dose group were gavaged with 0, 2.5, 5.0 or 10.0 mg/kg for 56 days prior to breeding and trhoughout the 10-day breeding period. Twenty -four female rats per dose group were given the same dose levels of monochloramine by gavage 14 days prior to breeding and throughout breeding, gestation, and lactation until the pups were weaned on day 21.
- Details on mating procedure:
- - M/F ratio per cage: 1/2
- Length of cohabitation:10-day breeding
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy
- After successful mating each pregnant female was caged (how): individually - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Males were exposed to chloramine for 56 days prior to breeding and throughout the 10-day breeding period.
Females were exposed for 14 days prior to breeding and throughout breeding, gestation and lactation until the pups were weaned on day 21. - Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
0, 2.5, 5.0, or 10 mg/kg
Basis:
nominal conc. - No. of animals per sex per dose:
- 12 male rats per dose
24 female rats per dose - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Doses chosen were the highest practicable considering solution stability and potential gastric irritation.
- Positive control:
- No
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes - Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- Parameters examined in male parental generations:
sperm count in epididymides, sperm motility, sperm morphology - Litter observations:
- Litters were evaluated for viability, litter size, day of eye opening, body weight gain, and gross external abnormalities. The day on which all pups in a litter had both eyes open was designated as the day of eye opening. At necropsy on lactation day 21, 10 pups/sex/dose were bled for complete blood counts and hormone
- Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: Following the breeding period.
- Maternal animals: On lactation day 21.
GROSS NECROPSY
- Gross necropsy consisted of reproductive tract examinations.
HISTOPATHOLOGY / ORGAN WEIGHTS
Male: The reproductive tract, including testis, epididymis, prostate, and seminal vesicles, was removed weighed, and, except for the right cauda epididymis, preserved in neutral buffered formalin for histopathologic evaluation
Female: The reproductive tract was removed, weighed, and preserved for histopahtologic evaluation. - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring were sacrificed on lactation day 21.
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:
GROSS NECROPSY
- Gross necropsy consisted of reproductive tract examinations.
HISTOPATHOLOGY / ORGAN WEIGTHS
Not performed. - Statistics:
- no statistics were performed.
- Reproductive indices:
- Not evaluated.
- Offspring viability indices:
- Not evaluated.
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- haematology
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- Reproductive effects observed:
- not specified
- Conclusions:
- No adverse reproductive effects following subchronic administration of chloramine were observed in this study.
- Executive summary:
The reproductive effects of chloramine administered by gavage in Long-Evans rats were examined. Males were treated for 56 days and females for 14 days prior to breeding and throughout the 10 -day breeding period. Females were treated throughout gestation and lactation. Following breeding, the males were necropsied and evaluated for sperm parameters and reproductive tract histopathology. adult females and some pups were necropsied at weaning on postnatal day 21. Other pups were treated postweaning until 28 or 40 days of age. These pups were evaluated for the day of vaginal patency and thyroid hormone levels. No differences were observed between control rats and those rats exposed to 10 mg/kg/day chloramine when fertility, viability, litte size, day of eye opening, or day of vaginal patency were evaluated. No alterations in sperm count, sperm direct progressive movement (µm/sec), percent motility, or sperm morphology were observed among adult male rats. In addition, male and female reproductive organ weights were comparable to their respective controls groups, and no significant histopathologic changes were observed among chloramine -treated male and female rats.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 10 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- One study available with a klimish score = 2.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
There is one data available for this endpoint.
In this teratogenic and reproductive toxicity assay, male long-evans rats were administered doses of 0, 2.5, 5 or 10 mg chloramine/kg by gavage for 56 days prior to breeding and throughout the 10 -day breeding cycle. Female rats received the same concentrations by gavage for 14 days prior to breeding and throughout breeding, gestation, and lactation, until the pups were weaned on day 21. No alterations in sperm count, sperm motility, or sperm morphology were observed. There were no dose-related effects on fertility, fetal viability, litter size, day of eye opening, or day of vaginal patency. The weights of male and female reproductive organs were not significantly different between the test and control groups, and no significant anatomical changes were seen on tissue examination. A NOAEL of 10 mg/kg of body weight per day was identified. (Carlton et., 1986).
Justification for selection of Effect on fertility via oral route:
Only one reproductive study available.
Justification for selection of Effect on fertility via inhalation route:
According to the oral available data, there is no indication of reprotoxicity. Therefore, additional inhalation testing would neither improve risk assessment nor safety of applications.
Justification for selection of Effect on fertility via dermal route:
According to the oral available data, there is no indication of reprotoxicity. Therefore, additional dermal testing would neither improve risk assessment nor safety of applications.
Effects on developmental toxicity
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- data not available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment. Nevertheless, a small number of animals were used (6 animals instead of 20/ group).
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Determination of the teratogenicity of monochloramine in rats, when administered prior to and throughout gestation. Six animals per group were administered 0, 1, 10 or 100 mg/l NH2Cl daily in the drinking water. After treatment for 2 1/2 months, the females were placed in the cages of untreated males in a ratio of 1 male : 3 females. Females with sperm-positive vaginal smears were placed in their original cages and allowed to drink their respective solutions throughout gestation. On day 20 of gestation females were killed and the numbers of live and dead foetuses were noted as well as resorptions. Individual foetal weights were recorded and a gross examination for external malformations was made.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: data not available
- Age at study initiation: Mature virgin female rat
- Weight at study initiation: 225-250 g
- Fasting period before study:
- Housing: three per cage
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): 50
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h light/ dark cycle. - Route of administration:
- oral: drinking water
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentration of monochloramine was then determined by titrating according to DPD method of Palin. This method also detects any small amounts of di- or trichloramines present in the solution. No trichloramine was found in the solutions, and the level of dichloramine was less than 1 % of the monochloramine concentration.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1 male : 3 females
- Length of cohabitation: no data
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- 2 1/2 months prior to and throughout gestation.
- Frequency of treatment:
- Daily in the drinking water.
- Duration of test:
- 2 1/2 months + breeding period + gestation period
- Remarks:
- Doses / Concentrations:
0, 1, 10 or 100 mg/l
Basis:
nominal in water - No. of animals per sex per dose:
- 6 animals per group
- Control animals:
- yes
- Maternal examinations:
- No data
- Ovaries and uterine content:
- No data
- Fetal examinations:
- - External examinations: Yes: [all per litter ]
- Soft tissue examinations: Yes: [half per litter]
- Skeletal examinations: Yes: [half per litter] - Statistics:
- Chi-square analysis was performed. (it is worth noting that the experimental unit used for all statistical analyses was the individual fetus rather than the maternal unit)
- Indices:
- No data
- Historical control data:
- No data
- Details on maternal toxic effects:
- Maternal toxic effects:no data
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/L drinking water
- Basis for effect level:
- other: no maternel effect toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/L drinking water
- Sex:
- female
- Basis for effect level:
- other: teratogenicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- Under the conditions of this test, monochloramine did not produce teratogenic effects in rats.
- Executive summary:
Female rats (6/group) were administered 0, 1, 10 and 100 mg/L of monochloramine daily in drinking water for 2 1/2 months prior to and throughout gestation. Female rats were sacrificed on Day 20 of gestation and fetus were examined for skeletal anomalies and other effects. Monochloramine did not produce any significant changes in rat fetuses at any dose level.
Reference
Viability of fetuses:
Upon sacrifice of the dams, all fetuses were found to be viable and normal in external appearance.
Fetal weights:
Fetal weights per group were analyzed by a two-way analysis of variance. The 10 and 100 mg/l of monochloramine groups of male fetuses and the 1, 10 and 100 mg/l groups of female fetuses all showed an increased fetal weight compared with the control group, but these findings were not significantly different from the control.
Types of skeletal anomalies:
In monochloramie treatment, all groups (except 1 mg/l group for missing sternebrae) were quite similar to the control values.
The total defects after monochloramine treatment in drinking water:
The percentage of skeletal, soft-tissue and total defects (combined skeletal and soft-tissue) was calculated. With monochloramine, although the percentage of skeletal defects in the fetuses of 10 mg/l group (47.8 %) was higher than in the control (34.5 %), chi-square analysis revealed no significant difference. A slight increase in soft-tissue defects was found at all dose levels of monochloramine. The defects in all of these groups, including the control group, consisted of adrenal agenesis, dextrocardia and improper orientation of the apex of the heart. The 1 mg/l monochloramine group had one fetus with the right testicle missing. The percentage of total defects in all of the monochloramine groups was very similar to that of the control group. the experimental unit used for all statistical analyses was the individual fetus rather than the maternal unit.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Study well documented, meets generally accepted scientific principles, acceptable for assessment. Nevertheless, a small number of animals were used (6 animals instead of 20/ group).
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
There is one data available for this endpoint.
In this teratology study, female Sprague-Dawley rats were administered monochloramine in drinking water at concentrations of 0, 1, 10, or 100 mg/L for 2.5 months prior to conception and throughout gestation. Rats were killed on day 20 of gestation, and the foetuses were examined for soft tissue and skeletal abnormalities. No increase in foetal resorptions was found in any treatment group. Monochloramine did not produce any significant changes in rat foetuses at any dose level. The reliability of these findings is reduced because of the small number of dams exposed and the lack of data on maternal toxicity (Abdel-Rahman et al., 1982).
Justification for selection of Effect on developmental toxicity: via oral route:
Only one study available.
Justification for selection of Effect on developmental toxicity: via inhalation route:
According to the oral available data, there is no indication of reprotoxicity. Therefore, additional dermal testing would neither improve risk assessment nor safety of applications.
Justification for selection of Effect on developmental toxicity: via dermal route:
According to the oral available data, there is no indication of reprotoxicity. Therefore, additional dermal testing would neither improve risk assessment nor safety of applications.
Justification for classification or non-classification
The available data on the potential toxicity to reproduction of the substance are conclusive but not sufficient for classification according to the DSD (67/548/EEC) and CLP (1272/2008/EC) criteria.
Additional information
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.
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