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EC number: 911-418-6 | CAS number: 55965-84-9
- 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:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-4 (Reproduction and Fertility Effects)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 87/302/EEC Part B
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan 59 Nohsan No. 4200
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Test material form:
- other: Amber liquid
- Details on test material:
- - Name of test material (as cited in study report):Kathon(TM) 886F biocide
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Rohm and Haas, Batch No. 0157A001
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Stable at room temperature
- Solubility and stability of the test substance in the solvent/vehicle: Soluble and stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Dilution in water
- Final dilution of a dissolved solid, stock liquid or gel: 30, 100, 300 ppm a.i.
OTHER SPECIFICS: Purity of test material was 14.8%
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Hollister, California, USA
- Age at study initiation: (P) 6-7 wks; (F1) 3 wks
- Weight at study initiation: (P) Males: 240-290 g; Females: 170-195 g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Prepared fresh once per week by diluting the test material with water
- Details on mating procedure:
- - M/F ratio per cage: 1 to 1
- Length of cohabitation: 2 weeks
- Proof of pregnancy: vaginal plug or sperm in vaginal smear, referred to as day 0 of pregnancy - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analytical results of the dosing solutions confirmed that the water preparation procedure provided homogeneous mixtures of the test substance in water, the Kathon™ 886F biocide concentrations ranged from 90-105 % of nominal target concentrations at all levels, and Kathon™ 885F biocide is stable in water for at least 14 days at room temperature.
- Duration of treatment / exposure:
- 10 weeks
- Frequency of treatment:
- Continuous, drinking water with test substance was renewed weekly
- Details on study schedule:
- - Selection of parents from F1 generation when pups were 21 days of age.
- Age at mating of the mated animals in the study: 6-7 weeks
Doses / concentrationsopen allclose all
- Dose / conc.:
- 30 ppm (nominal)
- Remarks:
- Based on a.i.
- Dose / conc.:
- 100 ppm (nominal)
- Remarks:
- Based on a.i.
- Dose / conc.:
- 300 ppm (nominal)
- Remarks:
- Based on a.i.
- No. of animals per sex per dose:
- 26/sex/group
- Control animals:
- yes, concurrent no treatment
- other: water with inorganic salt (stabilizer) content of highest dose
- Details on study design:
- - Rationale for animal assignment (if not random): Animals were assigned to dose groups using a computerized randomisation procedure based on body weight.
- Positive control:
- n/a
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Weekly
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly for male and female animals until cohabitation. Females weighed on Days 0,7, 14 and 21 of gestation, and Days 0,4,7, 14 and 21 of lactation. Determined every four weeks after cohabitation for unmated females and males for health monitoring purposes.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Weekly for male and female animals until cohabitation. During gestation, feed consumption was measured from Days 0-7, 7-14 and 14-2 1. Feed consumption was only measured during lactation from Days 0-7 and 7-14 due to the pups interfering with consumption from Days 14-21.
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Weekly for male and female animals until cohabitation. During gestation, water consumption was measured from Days 0-7, 7-14 and 14-2 1. Water consumption was only measured during lactation from Days 0-7 and 7-14 due to the pups interfering with consumption from Days 14-21. - Oestrous cyclicity (parental animals):
- During the three weeks immediately prior to mating, estrus cycling was evaluated in all P1 and P2 females by examination of cytology in daily vaginal lavage samples. This examination continued during cohabitation until positive evidence of mating was noted.
- Sperm parameters (parental animals):
- Parameters examined in P and F1 male parental generations:
sperm count in testes, sperm count in epididymides, enumeration of cauda epididymal sperm reserve, sperm motility, sperm morphology. - Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: yes
- If yes, maximum of 8 pups/litter (4/sex/litter were possible); excess pups were killed and discarded.
PARAMETERS EXAMINED
The following parameters were examined in F1 and F2 offspring:
number and sex of pups, stillbirths, live births, presence of gross anomalies, weight gain, physical or behavioural abnormalities
GROSS EXAMINATION OF DEAD PUPS:
yes, for external and internal abnormalities; possible cause of death was not determined for pups born or found dead. - Postmortem examinations (parental animals):
- SACRIFICE
- Maternal animals: All surviving animals after the last litter of each generation was weaned.
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGHTS
- Organ weights: adrenals, brain, kidneys, liver, spleen, thymus, ovary, uterus, testes, single epididymis (total and cauda), seminal vesicles (with coagulating glands and their fluids) and prostate.
- Tissues saved and fixed: adrenals, brain, kidneys, liver, pituitary, spleen, thymus, gross lesions, ovary, oviducts in females, uterus with cervix, testes, epididymis, seminal vesicles (with coagulating glands), prostate and stomach. - Postmortem examinations (offspring):
- SACRIFICE
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the thoracic and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGTHS
- Organ weights: brain, spleen, thymus on one pup/sex/litter at weaning post natal day 21.
- Microscopic examination of the stomach - Statistics:
- The litter (i.e., proportion of pups/litter, or litter mean) was used, where appropriate, as the experimental unit for the purpose of statistical evaluation. ANOVA and Fisher's Exact test were used to analyze the parameters studied. The level of statistical significance selected was p<0.05.
- Reproductive indices:
- Gestation index, mating index, fertility index.
- Offspring viability indices:
- Viability index, lactation index.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Males exposed to 300 ppm showed a treatment-related decrease (5 %) in mean body weight during weeks 1 through 6 of treatment.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Males exposed to 300 ppm showed a treatment-related decrease (5 %) in mean body weight during weeks 1 through 6 of treatment.
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Treatment-related and concentration-dependent decreases in water consumption were noted in all-Kathon™ exposed groups through most of the premating, gestation and lactation periods.
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- effects observed, treatment-related
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)
Treatment-related and concentration-dependent decreases in water consumption were noted in all-Kathon™ exposed groups in both the P1 and P2 animals through most of the premating, gestation and lactation periods.
HISTOPATHOLOGY (PARENTAL ANIMALS)
Treatment-related microscopic findings were limited to the stomach of male and female parental animals at 100 and/or 300 ppm. These changes included an increased incidence of focal superficial erosions of the glandular mucosa, edema and inflammation of the submucosa of the glandular and nonglandular areas, and hyperplasia and hyperkeratosis of the nonglandular stomach.
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 30 ppm
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Treatment-related and concentration-dependent decreases in water consumption were noted in all-Kathon™ exposed groups through most of the premating, gestation and lactation periods.
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Treatment-related microscopic findings were limited to the stomach of male and female parental animals at 100 and/or 300 ppm. These changes included an increased incidence of focal superficial erosions of the glandular mucosa, edema and inflammation of the submucosa of the glandular and nonglandular areas, and hyperplasia and hyperkeratosis of the nonglandular stomach.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not examined
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Effect levels (P1)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 30 ppm
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- histopathology: non-neoplastic
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 300 ppm
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- reproductive function (oestrous cycle)
- reproductive function (sperm measures)
- reproductive performance
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Other effects:
- not examined
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 300 ppm
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: reproduction and development
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Other effects:
- not examined
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not examined
Effect levels (F2)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 300 ppm
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- viability
- clinical signs
- histopathology: non-neoplastic
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Rats exposed to Kathon™ 886F biocide in the drinking water for two generations had a NOAEL for parental animal toxicity of 30 ppm (2.8-4.4 mg/kg/day in the P1 animals and 4.3-5.5 mg/kg/day in the P2 animals). The reproductive and developmental NOEL was 300 ppm (22.7-28.0 mg/kg/day in the P1 animals and 35.7-39.1 mg/kg/day in the P2 animals).
- Executive summary:
Kathon™biocide: two-generation reproductive toxicity study in rats. No treatment-related deaths or clinical signs of systemic toxicity in either sex up to and including 300 ppm. No treatment-related effects on body weights up to and including 100 ppm in males and females and 300 ppm in females. In 300 ppm males, a treatment-related decrease (5 %) in mean body weight was seen during weeks 1 through 6 of treatment. No treatment-related effects on premating feed consumption in either sex at any dose level. Treatment-related and concentration-dependent decreases in water consumption were noted in all-Kathon™ exposed groups in both the P1 and P2 animals through most of the premating, gestation and lactation periods. No treatment-related effects on any endpoint of mating or fertility in either generation at any dose level. No treatment related effects on sperm motility, testicular sperm count or caudal epididymal reserves of P1 and P2 males at any dose level. Treatment-related microscopic findings were limited to the stomach of male and female parental animals at 100 and/or 300 ppm. These changes included an increased incidence of focal superficial erosions of the glandular mucosa, edema and inflammation of the submucosa of the glandular and nonglandular areas, and hyperplasia and hyperkeratosis of the nonglandular stomach. Rats exposed to Kathon™ 886F biocide in the drinking water for two generations had a NOAEL for parental animal toxicity of 30 ppm (2.8-4.4 mg/kg/day in the P1 animals and 4.3-5.5 mg/kg/day in the P2 animals). The reproductive and developmental NOEL was 300 ppm (22.7-28.0 mg/kg/day in the P1 animals and 35.7-39.1 mg/kg/day in the P2 animals).
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