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EC number: 236-671-3 | CAS number: 13463-41-7
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-3 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pyrithione zinc
- EC Number:
- 236-671-3
- EC Name:
- Pyrithione zinc
- Cas Number:
- 13463-41-7
- Molecular formula:
- C10H8N2O2S2Zn
- IUPAC Name:
- Bis [1-hydroxy-2(1H)-pyridinethionato-O,S](T-4)-zinc
- Details on test material:
- Specification: 48% aq
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source: Hazelton Research Products, USA
Age at study initiation: 4-4.5 months
Weight at study initiation: 3101-4213g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Dose volume: 1 ml/kg
- Details on mating procedure:
- artificial insemination
- Duration of treatment / exposure:
- exposure: day 6-18 post mating
post-exposure: 11 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.5 mg/kg bw
Basis:
- Remarks:
- Doses / Concentrations:
1.5 mg/kg bw
Basis:
- Remarks:
- Doses / Concentrations:
3.0 mg/kg bw
Basis:
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Body weight: gestation days 0, 6, 12, 19, 24, 29
Clinical signs: dilay dusring gestation days 6-29 - Ovaries and uterine content:
- Gravid uterine weight
Number of corpora lutea
Number of implantations - Fetal examinations:
- Litter size
Number of dead foetuses
Foetal weight
Sex ratio
Skeletal anad soft tissue - Statistics:
- All statistical analyses compared the treatment groups with the control with levels of significance at p≤0.05 and p≤0.01. All means values included the standard deviation. Statistical tests were performed using a VAX computer and SAS or in-house statistical software.
Mean maternal body weights, body weight changes, food consumption, mean numbers of corpora lute, total implantations, live foetuses, mean fatal body weights, and mean gravid uterine weights were compared by analysis of variance (one-way), Bartlett’s test for homogeneity of variance and the appropriate t-test (for equal and unequal variance) using Dennett’s multiple comparison tables or pair wise comparisons with a Bonfarroni correction to determine the significance of differences.
Fetal sex ratios and the proportion of litters with malformations and developmental variations were compared using the Chi-square test for homogeneity of R x C contingency tables to determine the significance of differences.
The proportions of resorbed and dead fetuses and post-implantation losses were compared using the Kruskal-Wallis test. If the test was statistically significant (p≤0.05), then the Mann-Whitney U-test with a Bonfarroni correction was used to determine the significance.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Deceased weight gain in the 1.5-mg/Kg and 3.0-mg/Kg dose groups during gestation days 6-12, and decreased weight gain in the 1.5-mg/Kg dose group and weight loss in the 3.0-mg/Kg dose group during gestation days 12-19. Reduced food consumption in the 1.5-mg/Kg and 3.0-mg/Kg dose groups during the treatment period.
Aside from one death in the 1.5-mg/Kg dose group, the only significant clinical observations were an increased incidence of red fluid in the refuse pan in the 3.0-mg/Kg dose group, and decreased defecation relative to the controls in all of the treatment groups. Based on the necropsy results, a gavage error during dosing was considered as a possible cause for the single death. There were no fatalities in the control, 0.5-mg/Kg, and 3.0-mg/Kg groups.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 1.5 mg/kg bw/day (nominal)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 0.5 mg/kg bw/day (nominal)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
1.1 Teratogenic / embryo¬toxic effects Uterine effects were seen in the 1.5 mg/Kg (mid dose) and 3.0-mg/Kg (high dose) groups. These included: one animal in the 3.0-mg/Kg group aborted on gestation day 27; whole litter resorption in one mid dose animal and 5 high dose animals; and an increase in the mean post-implantation loss and a decrease in the mean number of viable fetuses. The reduced number of viable fetuses also resulted in reduced mean uterine weights in these groups, although the mean fetal weights were comparable those in the control group. In addition there was a slight reduction in the number of implantations compared with the control group, which was mainly due to the increased post-implantation losses. There were no significant differences in the mean number of corpora lutea and the fetal sex ratio compared to the controls.
All parameters in the 0.5-mg/Kg (low dose) group were similar to those in the control group.
Developmental effects to the fetus were observed only at the high dose and included an increase in the incidence of malformations, primarily in the cephalic and limb regions. Three fetuses from two litters showed multiple cephalic and limb malformations. A forth fetus from one of these litters showed a vertebral malformation with associated rib malformation. There were no treatment-related or statistically significant differences in the incidence of malformations between the control and the low-dose or mid-dose groups. There were no dose -related differences in the incidence of developmental variations between the control and any treatment group.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 1.5 mg/kg bw/day (nominal)
- Basis for effect level:
- other: embryotoxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 0.5 mg/kg bw/day (nominal)
- Basis for effect level:
- other: embryotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL = 0.5 mg/kg. The information contained within this robust summary document comes from studies which are in the ownership of Arch Chemicals Inc. and which are protected in several regions globally. This information may not be used for any purpose other than in support of the Chemical safety Report submitted by Arch Chemicals Inc. under Regulation EC 1907/2006.
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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