Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Toxicity to reproduction
Administrative data
- 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.
Data source
Reference
- Reference Type:
- publication
- Title:
- Reproductive effects of alternative disinfectants
- Author:
- Carlton B.D., Barlett P., Basaran A., Kate Colling K., Osis I., and Smith M.K.
- Year:
- 1 986
- Bibliographic source:
- Environmental Health Perspective, Vol. 69, pp. 237-241, 1986.
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Chloramide
- EC Number:
- 234-217-9
- EC Name:
- Chloramide
- Cas Number:
- 10599-90-3
- Molecular formula:
- ClH2N
- IUPAC Name:
- chloranamine
- Test material form:
- other: in solution
- Details on test material:
- Chloramine stock solution was prepared by titrating chlorine stock solution with ammonia.
Constituent 1
Test animals
- 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
Administration / exposure
- 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
Doses / concentrations
- 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
Examinations
- 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.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- 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 / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- 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
Results: F1 generation
General toxicity (F1)
- 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
Details on results (F1)
Effect levels (F1)
- 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
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- 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.
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.