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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- 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 82-3 (Subchronic Dermal Toxicity 90 Days)
- 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:
- 52.2% zinc pyrithione with sodium naphthal enesulphonic acud polymer (surfactant)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CrlCD BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Charles River Laboratories USA
Age at study initiation: 8 weeks
Weight at study initiation: male 244-305g female 174-200g
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on exposure:
- Application area: 3x5cm
- Details on analytical verification of doses or concentrations:
- Dose volume: 2 ml/kg
- Duration of treatment / exposure:
- 13 weeks
6h/day - Frequency of treatment:
- 5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
20 mg/kg
Basis:
- Remarks:
- Doses / Concentrations:
100 mg/kg
Basis:
- Remarks:
- Doses / Concentrations:
1000 mg/kg
Basis:
- No. of animals per sex per dose:
- 15
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- clinical observations: twice daily, weekly detailed observations
mortality: twice daily
body weight: weekly
food consumption: weekly
ophthalmoscopic: pre-test and 13 weeks
haematology: end of study
clinical chemistry: end of study
urinalysis: end of study - Sacrifice and pathology:
- Organ weights: liver, kidney, testes, brain
gross and histopathology: brain, spinal cord, pituitary, thyroid, parathyroid, thymus, oesophagus, salivary glands, stomach, small and large intestines, liver, pancreas, kidneys, adrenals, spleen, heart, trachea, lungs, aorta, gonads, uterus, female mammary gland, prostate, urinary bladder, lymph nodes, peripheral nerve, bone marrow, skin, eyes, bone, lachrymal gland, sciatic nerve, and skeletal muscle. In addition, the liver, kidneys, and lungs from the 20-mg/Kg and 100 mg/Kg groups were examined microscopically. - Statistics:
- Body weights, food consumption, hematological, biochemical and urinalysis values, and absolute and relative organ weights were analyzed using analysis of variance (one-way classification) and Bartlett’s test for homogeneity of variance. Treatment groups were compared to the control group by sex using the appropriate t-statistic (for equal or unequal variance) as described by Steel and Torrie1. Dunnett’s2 multiple comparison tables or pairwise comparisons with a Bonferroni correction were used to determine the significance of differences. Nonparametric analyses were conducted as appropriate by transforming the data into ranks prior to analysis, as described by Conover and Iman3. All statistical analyses were performed with p ≤ 0.05 and p ≤ 0.01 used as levels of significance.
1 Steel, RGD and Torrie, JH (1980). Principles and Procedures of Statistics, McGraw-Hill Book Co., Inc., New York, NY, 2nd ed., 471-472.
2 Dunnett, CW (1964). New tables for multiple comparisons with a control. Biometrics, 20; 482-491.
3 Conover, WJ and Iman, RL (1981). Rank transformations as a bridge between parametric and nonparametric statistics. The American Statistician. 35; 124-133.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- Dermal irritation: Slight dermal irritation seen in the 1,000-mg/Kg dose group in one male (red foci and desquamation on day 29 and 30) and one female (red foci on days 29, 30, and 33).
Body weight gain: Depression in body weight gain in females in the 1,000-mg/Kg dose group. Body weight gain was depressed for the first four weeks of dosing; thereafter, weight gain was similar to controls, but absolute weights remained depressed. No effects were seen in the males.
Food consumption: Depressed in females in the 1,000-mg/Kg dose group. Food consumption was depressed for the first four weeks of dosing; thereafter, food consumption was similar to controls. No effects were seen in the males.
Haematology: Statistically significant differences between the dose groups and the controls were elevated leukocyte counts in the 1,000-mg/Kg males (14.2 vs. 11.0), depressed erythrocyte count in the 1,000-mg/Kg females (6.39 vs. 6.78), and depressed hematocrit level in the 1,000-mg/Kg females (39.2 vs. 41.2). These results were not considered test material related since all values were within the laboratories normal control range, and microscopic evaluations did not indicate any abnormalities that might produce such changes
Clinical chemistry: The only statistically significant difference between the dose groups and the controls was elevation in cholesterol in the 1,000-mg/Kg females (88 vs. 69).
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Dose descriptor:
- LOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL=100mg/kg bw/day. 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.
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.