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EC number: 293-309-7 | CAS number: 91053-44-0 Residues obtained by cementation of cadmium by iron dust out of cadmium sulfate solutions. Composed primarily of metallic cadmium and zinc.
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: 13-wk inhalation toxicity study
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- No information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: reliable without restrictions. Generally in compliance with OECD TG 413 and EC TM B26 Dir. 87/302/EEC 30/05/88.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD TG 413 and EC TM B26 Dir. 87/302/EEC 30/05/88
- Deviations:
- not specified
- Principles of method if other than guideline:
- A study was conducted to determine the effects of sub-chronic exposure of the test material on the reproductive system in F344 rats.
The test material was administered 6 h/d and 5 d/wk for 13 wk at 0, 0.025, 0.05, 0.1, 0.25 or 1 mg/m3 to groups of 10 rats/sex/dose. Animals were observed twice daily for mortality and signs of toxicity and were weighed on Day 1, weekly thereafter and on the day of necropsy with clinical signs being observed daily. Following organs were weighed at necropsy: heart, right kidney, liver, lungs, spleen, right testis and thymus. Additionally, Cd distribution study and influence on blood pressure was evaluated. Additionally, sperm motility and vaginal cytology evaluations were performed on base study animals in the 0, 0.025, 0.1 and 1 mg/m3 groups at the end of study. Male rats were evaluated for necropsy body and reproductive tissue weights, spermatozoal data and spermatogenesis. Females were evaluated for necropsy body weight, estrous cycle length and the percent of cycle spent in the various stages. - GLP compliance:
- yes
- Remarks:
- in compliance with United States FDA GLP regulations (21 CFR, Part 58)
- Limit test:
- no
Test material
- Reference substance name:
- Cadmium oxide
- EC Number:
- 215-146-2
- EC Name:
- Cadmium oxide
- Cas Number:
- 1306-19-0
- IUPAC Name:
- oxocadmium
- Details on test material:
- -Name of test material-CdO
SOURCE: Lot 110383 from Johnson Matthey Aesar Group (Seabrook, NH)
PURITY: 99.4 %
Impurities : 400 ppm chlorine, all other impurities detected totalled less than 263 ppm
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Simonsen Laboratories (Gilroy, CA)
- Age at study initiation: 6 wk
- Weight at study initiation: rat: Male: 101-104 g (mean body weight per group); Female: 92-94 g (mean body weight per group)
- Housing: in individual cages within the exposure chambers
- Diet : NIH-07 Open Formula Diet (Zeigler Brothers, Inc., Gardners, PA) in pellet form
- Water : City water (Richland, WA), ad libitum
- Acclimation period: 12-15 d
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Particle size: MMAD = 1.1 - 1.6 µm, GSD : 1.7-1.8
- Details on mating procedure:
- none
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentrations were monitored automatically (measured concentrations within 85% of nominal conc)
- Duration of treatment / exposure:
- 13 wk
- Frequency of treatment:
- 6h/d; 5 d/wk
- Details on study schedule:
- No information
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.025, 0.05, 0.1, 0.25 and 1 mg CdO/m3
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10 males and 10 females per dose
- Control animals:
- yes
- Details on study design:
- Post exposure period:no
Satellite groups and reasons they were added : additional 10 male & 10 female rats used for hematology and clinical chemistry evaluations and additional 20 males rats (0, 0.1, 0.25 and 1 mg/m3) used for Cd tissue distribution. - Positive control:
- none
Examinations
- Parental animals: Observations and examinations:
- PARAMETERS ASSESSED DURING THE STUDY:
- Clinical observations performed and frequency: animals were observed twice daily for mortality and signs of toxicity and were weighed on Day 1, weekly thereafter and on the day of necropsy. Clinical observations were recorded weekly.
Supplemental evaluations :
- clinical pathology (hematology, clinical chemistry, urine analysis),
- blood pressure measurements,
- Cd tissue distribution (blood, lung and kidney samples collected on Days 3, 9, 30, end of study), see rep dose tox study - Oestrous cyclicity (parental animals):
- Females were evaluated for necropsy body weight, estrous cycle length and the percent of cycle spent in the various stages.
- Sperm parameters (parental animals):
- Sperm motility and vaginal cytology : evaluations were performed on base study animals in the 0, 0.025, 0.1 and 1 mg/m3 groups at the end of study. Male rats were evaluated for necropsy body and reproductive tissue weights, spermatozoal data and spermatogenesis.
- Litter observations:
- Not examined
- Postmortem examinations (parental animals):
- Autopsy: complete necropsies were performed on all base-study animals. The following organs were weighed : heart, right kidney, liver, lungs, spleen, right testis and thymus. Histopathologic evaluations were performed on all animals in the 0 and 1 mg/m3 groups. The following organs were examined in the lower exposure groups : larynx, lungs, lymph nodes and nasal cavity.
- Postmortem examinations (offspring):
- Not examined
- Statistics:
- Organ and body weight data, which have approximately normal distributions, were analyzed with the parametric multiple comparison procedures of
Williams (1971, 1972) and Dunnett (1955). Clinical pathology, spermatid, epididymal spermatozoa data and Cd tissue concentrations were analyzed
with the nonparametric multiple comparison methods of Shirley (1977) and Dunn (1964). Jonckheere's test (Jonckheere 1954) was used to assess
the significance of dose-response trends and to determine whether a trend-sensitive test (Williams' or Shirleys' test) was more appropriate for
pairwise comparisons than a test that does not assume a monotonic dose-response (Dunnett's or Dunn's test). Trend-sensitive tests were used when Jonckheere's test was significant at a P-value less than 0.1. For indirect systolic blood pressure measurements, a one-way analysis of variance test
(Weter et al, 1985) was used to assess dose-response and time-response trends. For analysis of vaginal cytology data, because the data are
proportions (the proportion of the observation period that an animal was in a given estrous stage), an arcsine transformation was used to bring the
data into closer conformance with normality assumptions. Treatment effects were investigated by applying a multivariate analysis of variance
(Morrison, 1976) to the transformed data to test for simultaneous equality of measurements across dose levels. - Reproductive indices:
- Not examined
- Offspring viability indices:
- Not examined
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, treatment-related
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Reproductive performance:
- not examined
Details on results (P0)
For detailed data on toxicity : see 7.5.3 Repeated dose toxicity: inhalation
Reproductive toxicity : in males in the 1 mg/m3 group, spermatid heads per gram of testis, spermatid heads per testis and spermatid count were significantly lower than those of control males. There were no treatment-related microscopic changes in the testis or epididymis. In females, there was a significantly greater estrous cycle length than the controls at the 1 mg/m3 exposure level, but no treatment-related histologic changes in the reproductive organs.
Effect levels (P0)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 1 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: Decrease in spermatid head count and spermatid count in testes; increase in estrous cycle length
- Dose descriptor:
- NOAEL
- Effect level:
- 0.1 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: Decrease in spermatid head count and spermatid count in testes; increase in estrous cycle length
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Details on results (F1)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Conclusions:
- In rats at the highest exposure level (1 mg/m3), there was a reduced number of spermatids per testis and an increase in the length of the estrous
cycle. However, there were no histopathologic lesions indicative of toxicity to the reproductive system, suggesting that the changes may be related to other effects of cadmium, such as hormonal modifications. - Executive summary:
A study was conducted to determine the effects of sub-chronic exposure of the test material on the reproductive system in F344 rats.
The test material was administered 6 h/d and 5 d/wk for 13 wk at 0, 0.025, 0.05, 0.1, 0.25 or 1 mg/m3 to groups of 10 rats/sex/dose. Animals were observed twice daily for mortality and signs of toxicity and were weighed on Day 1, weekly thereafter and on the day of necropsy with clinical signs being observed daily. Following organs were weighed at necropsy: heart, right kidney, liver, lungs, spleen, right testis and thymus. Cd distribution and influence on blood pressure was evaluated. Additionally, sperm motility and vaginal cytology evaluations were performed on base study animals in the 0, 0.025, 0.1 and 1 mg/m3 groups at the end of study. At necropsy, body and reproductive tissue weights, spermatozoal data and spermatogenesis were recoirded for males. Females were evaluated at necropsy for bodyweight, estrous cycle length and the percent of cycle spent in the various stages.
Available results indicate enlargement and paleness of the tracheobronchial and mediastinal lymph nodes in the treated groups. Overall, treatment-related respiratory tract lesions were found in the lungs, nose and larynx of FN344/N rats exposed by inhalation to CdO for 13 wk.
Reproductive toxicity was observed in the 1mg/m3 groups of rats and was evidenced by a reduced number of spermatids per testis and an increase in the length of the estrous cycle.
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