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EC number: 231-668-3 | CAS number: 7681-52-9
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Stability in organic solvents and identity of relevant degradation products
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- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
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- Environmental data
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- 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
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- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
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- Additional toxicological data

Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test guideline (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: No deficiencies.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Deviations:
- yes
- Remarks:
- dose administration to males only 8 weeks instead of 10 as recommended by the guideline
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Long-Evans
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Charles River Breeding Laboratories, Portage, USA
4-6 weeks old, weight not stated - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Total volume applied: 10 mL/kg
- Details on mating procedure:
- One male housed with two females throughout breeding period.
Duration of mating: 10 days - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Duration of exposure before mating
Males: 56 days; Females: 14 days
Duration of exposure in general P, F1
Males: 56 days prior to breeding and throughout the 10-day breeding period.
Females: 14 days prior to breeding and throughout breeding, gestation and lactation until pups were weaned on day 21. - Frequency of treatment:
- daily
- Details on study schedule:
- Male were dosed 56 days prior and throuout breeding, females were dosed 14 days prior to breeding, throughout breeding, gestation and lactation until day 21 of lactation.
- Remarks:
- Doses / Concentrations:
1, 2, or 5 mg/kg bw/day
Basis:
nominal conc. - No. of animals per sex per dose:
- 12 males, 24 females
- Control animals:
- yes, concurrent vehicle
- Parental animals: Observations and examinations:
- Clinical signs Yes
Body weight Yes - Oestrous cyclicity (parental animals):
- Not stated
- Sperm parameters (parental animals):
- Testis weight
Epididymides weight
Sperm motility
Sperm morphology
Sperm concentration in epididymides - Litter observations:
- Number of pups
Stillbirths
Litter size
Live births
Presence of gross anomalies
Weight gain
Weight of reproductive organs
Day of eye opening
Complete blood counts
Hormone analysis
Vaginal patency - Postmortem examinations (parental animals):
- Organ weights P and F1:
Female reproductive tract
Testes
Epididymides (total and cauda)
Prostate
Seminal vesicles
Histopathology P and F1
Organs of the reproductive tract - Postmortem examinations (offspring):
- Organ weights P and F1:
Female reproductive tract
Testes
Epididymides (total and cauda)
Prostate
Seminal vesicles
Histopathology P and F1
Organs of the reproductive tract - Statistics:
- not stated
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not examined
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Dose descriptor:
- LOAEL
- Effect level:
- > 5 mg/kg bw/day (nominal)
- Sex:
- male/female
- Dose descriptor:
- NOAEL
- Effect level:
- >= 5 mg/kg bw/day (nominal)
- Sex:
- male/female
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- > 5 mg/kg bw/day (nominal)
- Sex:
- male/female
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 5 mg/kg bw/day (nominal)
- Sex:
- male/female
- Reproductive effects observed:
- not specified
- Conclusions:
- LO(A)EL
Parent males > 5.0 mg/kg bw/day
Parent females > 5.0 mg/kg bw/day
F1 males > 5.0 mg/kg bw/day
F1 females > 5.0 mg/kg bw/day
NO(A)EL
Parent males ≥ 5.0 mg/kg bw/day
Parent females ≥ 5.0 mg/kg bw/day
F1 males ≥ 5.0 mg/kg bw/day
F1 females ≥ 5.0 mg/kg bw/day - Executive summary:
- No differences were observed between control rats and those rats exposed to up to 5 mg/kg bw/day of the test material when fertility, viability, litter size, day of eye opening or day of vaginal patency were evaluated. No alterations in sperm count, sperm direct progressive movement, percent motility or sperm morphology were observed among adult male rats. In addition, male and female reproductive organ weights were comparable to the control groups and no significant histopathological changes were observed among treated male female rats.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 5 mg/kg bw/day
Additional information
The reproductive effects of chlorinated water have been examined in a one-generation gavage study in rats (Carlton et al. 1986). 12 males were treated with 0, 1, 2 and 5 mg av Cl/kg bw/d for 56 days and 24 females for 14 days prior to breeding and throughout the 10-day breeding period. Additionally, females received the hypochlorite solutions 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 post weaning until 28 or 40 days of age. These pups were evaluated for the day of vaginal patency and for thyroid hormone levels. No differences were observed between control rats and those rats exposed to up to 5 mg av Cl/kg bw/d of the test material when fertility, viability, litter size, day of eye opening or day of vaginal patency were evaluated. No alterations in sperm count, sperm direct progressive movement, percent motility or sperm morphology were observed among adult male rats. In addition, male and female reproductive organ weights were comparable to the control groups and no significant histopathological changes were observed among treated male and female rats.
In a multi-generation study highly chlorinated water, containing available chlorine at a level of 100 mg/L (corresponding to 5 mg/kg bw/d), was administered daily as drinking water to 236 BD II rats over seven consecutive generations (Duckrey 1968). The first generation received the treated drinking water from an age of 100 days on, subsequent generations were treated throughout the lifetime with the exception of F3 and F4, which were treated only until weaning of their pups. Effects on the lifespan, fertility, growth, blood, organ weights and histopathology were recorded. There were no significant differences between control (2 groups of BD II rats, a total of 56 animals) and treated animals with respect to lifetime, fertility, breeding outcome, clinical signs, organ weights, haematological parameters, histopathology, neoplastic lesions. Based on this finding the parental, reproductive and developmental NOAEL is considered to be greater than 5 mg av Cl/kg bw/d.
To examine the effects on the reproductive performance groups of C3H/HeJ and C57BL/6J mice were treated with chlorinated water (10 ppm; corresponding to 1.7 mg/kg bw/d (males) and 2 mg/kg bw/d (females) acidified with hydrochloric acid (pH 2.5) over a period of 6 months (Les 1968). Males and females were housed in pairs or trios and the number of pups born and weanlings were recorded. There were no adverse effects on the reproductive performance observed. Treated C3H/HeJ mice showed increased numbers of pups born and weaned in total and per dam compared to control. The percentage weaned of those born was practically identical. Treated C57BL/6J mice showed a higher reproductive performance in all evaluated parameters if the type of mating (pairs or trios) is disregarded. The number of mice weaned in the C3H/HeJ treatment group was 5.7 % greater than in the control group. In treated C57BL/6J mice the number of weaned pups was 17.5 % greater than in the respective control. There is no detrimental effect on the reproduction of mice treated with chlorinated and acidified water (10 ppm, pH 2.5); on the contrary, reproductive performance in treated animals was statistically significantly increased when compared to control. The parental, reproductive and developmental NOAEL is considered to be greater than 1.7 mg av Cl/kg bw/d (males) and 2 mg av Cl/kg bw/d (females).
Short description of key information:
There are no relevant studies of sodium hypochlorite per se looking at its reproductive toxicity potential in animals. No significant effects were seen in a well conducted one generation reproductive toxicity study in rats up to a concentration of 5 mg/kg bw of aqueous chlorine as well as in teratogenicity studies in rats and mice.
This value is further supported by another multi-generation study, in which also no effects were noted at doses of 5 mg/kg bw/day. Long-term toxicity studies provide also additional assurance that the substance is not a reproductive toxicant as they did not identify the testes or ovaries as target organs. Thus, the NOAEL derived by the author was set to > 5.7 mg available Cl/kg bw/day.
Effects on developmental toxicity
Description of key information
One study with clorine is available. There were no treatment-related changes in viability, foetal weights and external appearance of all foetuses in all dose groups. Skeletal and soft-tissue defects were in the normal range for all dose groups. The NOAEL was set to > 5.7 mg available Cl/kg bw/day.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Deficiency: Yes. Maternal toxicity not evaluated.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- maternal effects not stated, treatment period longer than required (2 ½ months plus gestation)
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- Age/weight at study initiation: Mature, 225-250 g
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- not stated
- Duration of treatment / exposure:
- 2 1/2 months, prior to and throughout gestation
- Frequency of treatment:
- ad libitum
- Duration of test:
- 2 1/2 months, prior to and throughout gestation
- Remarks:
- Doses / Concentrations:
0, 1, 10, 100 ppm corresponding to approximately 0, 0.08, 0.8, 8.0 mg/kg bw/day (assuming a water intake of 25 mL/rat/day and a body weight of 320 g)
Basis:
nominal conc. - No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Sex: female
- Maternal examinations:
- not determined
- Ovaries and uterine content:
- Examination of uterine content: Number of resorptions
- Fetal examinations:
- No. of dead Foetuses, Foetal Weight
Skeletal Yes
Soft tissue Yes - Statistics:
- Chi-square analysis
- Details on maternal toxic effects:
- Maternal toxic effects:not examined
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There was no treatment related effect on viability, external appearance and foetal weight. The percentage of skeletal, soft-tissue and total defects (combined skeletal and soft-tissue) was calculated and presented in the table. The foetuses from the 10 and 100 mg/L groups had a higher percentage of skeletal defects compared with control. However, these did not achieve statistical significance. The highest dose group also showed a higher rate of soft-tissue defects, again without achieving statistical significance when compared to control by chi-square analysis. These defects consisted of three cases of adrenal agenesis, one right-sided heart, one case of improper orientation of the apex of the heart, and one atrio-ventricular valve enlargement. Total defects were statistically higher in the high dose group than in control, whereas the lowest dose produced a lower percentage of defects than control. - Dose descriptor:
- NOAEL
- Effect level:
- >= 5.7 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- LOAEL
- Effect level:
- > 5.7 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- A NO(A)EL for embryotoxic / teratogenic effects of >= 100 ppm corresponding to 5.7 mg/kg bw/day and a LO(A)EL for embryotoxic / teratogenic effects of > 100 ppm corresponding to 5.7 mg/kg bw/day were found.
- Executive summary:
- There were no treatment-related changes in viability, foetal weights and external appearance of all foetuses in all dose groups. Skeletal and soft-tissue defects were in the normal range for all dose groups. If skeletal and soft-tissue defects were combined a statistically significant increase was observed in the highest dose group. In the absence of a clear dose response and a relatively high incidence of defects in control animals, these findings were not considered to be of relevance. The authors conclude that chlorinated drinking water at the tested concentrations is relatively harmless to the rat when fed to pregnant dams. Unfortunately maternal toxicity was not evaluated. However, subchronic studies show that the NOAEL is 50 mg/kg bw/day.
Reference
Effect of chlorine in drinking water on the formation of skeletal and soft-tissue defects in rat foetuses.
Concentration [ppm] |
Skeletal defects [%]a |
Soft-tissue defects [%]a |
Total defects [%]a |
0 |
34.5 |
7.1 |
21.1 |
1 |
23.8 |
0.0 |
12.2 |
10 |
59.1 |
0.0 |
27.1 |
100 |
57.7 |
19.2 |
38.5b |
a Values represent % of defects for all foetuses in each treatment
b Statistically different from control (p < 0.05), chi-square analysis
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 5.7 mg/kg bw/day
Additional information
In a teratogenicity study (Abdel-Rahman et al. 1982), groups of 6 female Sprague-Dawley rats were exposed to concentrations of 0, 1, 10 and 100 mg/L hypochlorite in drinking water (corresponding to 0.057, 0.57 and 5.7 mg av Cl/kg bw/d) for 2 ½ months prior to and throughout gestation. Rats were sacrificed on day 20 of gestation and foetuses were preserved for soft-tissue and skeletal examination. There were no treatment-related changes in viability, foetal weights and external appearance of all foetuses in all dose groups. Skeletal and soft-tissue defects were in the normal range for all dose groups. If skeletal and soft-tissue defects were combined a statistically significant increase was observed in the highest dose group. In the absence of a clear dose response and a relatively high incidence of defects in control animals, these findings were not considered to be of relevance. It was concluded that chlorinated drinking water at the tested concentrations is relatively harmless to the rat when fed to pregnant dams. The NOAEL for embryotoxic and teratogenic effects was considered to be greater than 5.7 mg av Cl/kg bw/d. Toxic effects on dams were not reported in this study. However, in subchronic studies which were performed at even higher dose levels than those administered in the rat teratogenicity study demonstrate an NOAEL of 57.2 mg av Cl/kg bw/d.
Justification for classification or non-classification
Although limited data are available in animals, the available studies are sufficient in their design and quality to draw the conclusion that there is no evidence to suggest that sodium hypochlorite would present adverse effects on development or fertility. Similarly, no such evidence is forthcoming from epidemiological studies on populations consuming chlorinated drinking water. Thus, sodium hypochlorite is not classified reprotoxic according to 67/548/EEC and CLP.
Additional information
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