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EC number: 807-374-1 | CAS number: 2540-36-5
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
Effect on fertility: via dermal route
- Endpoint conclusion:
- no adverse effect observed
Additional information
- Rodents, full set (AO1, 791 records)
- Rodents part A (AO2, 608 records)
- Rodents part B (AO3,607 records)
- Rat, full set (AO4,721 records)
- Rat, part A (AO5,553 records)
- Rat, part B (AO6,553 records)
- Mouse, full set (AO7,146 records)
- Mammal, full set (AP1,917 records)
- Mammal, part A (AP2,575 records)
- Mammal, part B (AP3,574 records)
- Rat, full set (AP4,730 records)
- Rat, part A (AP5,452 records)
- Rat, part B (AP6,452 records)
- Mouse, full set (AP7,262 records)
- toxicity in females
- Rodents, full set (AN1, 968 records)
- Rodents part A (AN2, 424 records)
- Rodents part B (AN3, 424 records)
- Rodents part C (AN4, 39 records)v
- Rat, full set (AN5,902 records)
- Rat, part A (AN6,455 records)
- Rat, part B (AN7,455 records)
- Rat, part C (AN8,454 records)
- Mouse, full set (AN9,151 records)
The results should be considered together with the results of test with the 3FDA Reprotox sets, designed from the FDA archives and openly published results of reproductive toxicity tests date for:
Reproductive toxicity in adult males
Sperm toxicity
Reproductive
The results of tests with the FDA ReproTOX sets are summarized in the following tables.
Important notice:The RCA method expert call is a computer-generated output that is considered, along with other available information, in formulating the final conclusion.The Final Conclusion is a conclusion made by the reviewer, taking into account all the available evidence, including thein-silicoand available experimental results.
Table 1. Reproductive toxicity in male adult rodents
Compound |
AO1 |
AO2 |
AO3 |
RCA Method Expert Call (Overall) |
Review expert |
O-ethyl dithiocarbonic acid |
- |
- |
- |
-* |
- |
Table 2. Reproductive toxicity in male adult rats
Compound |
AO4 |
AO5 |
AO6 |
RCA Method Expert Call (Overall) |
Review expert |
O-ethyl dithiocarbonic acid |
- |
- |
- |
-* |
- |
Table 3. Reproductive toxicity in male adult mice
Compound |
AO7 |
RCA Method Expert Call (Overall) |
Review expert |
O-ethyl dithiocarbonic acid |
+ |
?* |
- |
Table 4. Sperm toxicity in male adult rodents
Compound |
AP1 |
AP2 |
AP3 |
RCA Method Expert Call (Overall) |
Review expert |
O-ethyl dithiocarbonic acid |
- |
- |
- |
-* |
- |
Table 5. Sperm toxicity in male adult rats
Compound |
AP4 |
AP5 |
AP6 |
RCA Method Expert Call (Overall) |
Review expert |
O-ethyl dithiocarbonic acid |
- |
- |
- |
-* |
- |
Table 6. Sperm toxicity in male adult mice
Compound |
AP7 |
RCA Method Expert Call (Overall) |
Review expert |
O-ethyl dithiocarbonic acid |
- |
-* |
- |
Table 7. Reproductive toxicity in female adult rodents
Compound |
AN1 |
AN2 |
AN3 |
AN4 |
RCA Method Expert Call (Overall) |
Review expert |
O-ethyl dithiocarbonic acid |
- |
- |
- |
- |
-* |
- |
Table 8. Reproductive toxicity in female adult rats
Compound |
AN5 |
AN6 |
AN7 |
AN8 |
RCA Method Expert Call (Overall) |
Review expert |
O-ethyl dithiocarbonic acid |
- |
- |
- |
- |
-* |
- |
Table 9. Reproductive toxicity in female adult mice
Compound |
AN9 |
RCA Method Expert Call (Overall) |
Review expert |
O-ethyl dithiocarbonic acid |
- |
-* |
- |
Table 10. Summary of the results and overall conclusions for the reproductive toxicity tests
Compound |
Fertility males |
Sperm toxicity |
Fertility females |
The FINAL conclusion |
||||||
Rodnts |
Rats |
Mice |
Rodnts |
Rats |
Mice |
Rodnts |
Rats |
Mice |
||
O-ethyl dithiocarbonic acid |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
The RCA paradigm, implemented in the RCA decision support system, requires the following criteria for a chemical to be designated as POSITIVE:
1. To be active in more than one test assay within a test battery
2. To be active in a test assay, there must be two or more structurally similar fragments across the modules of the test assay.
Tables 1 - 10 reveal these conditions were not met by test compound in FDA Reproductive Toxicity Set. The unknown structural features, which were detected in all test batteries, do not resemble the main structural units of well known developmental toxicant CS2. The tested substance was reported in NICNAS Priority existing chemical assessment report (1995, Vol.6, 66p) and it was not listed there as developmental toxicant for humans, as long as it is used in the conditions, preventing its decomposition, producing carbon disulfide. The Final conclusion is that the tested chemical is considered to be nonthreatening to humans from this evaluation.
The tested molecule does not contain any confirmed alerts and is assumed to be inactive.
The RCA reasoning tool, based on the weight of evidence approach, should be applied. This set of rules was developed and refined to assist the U.S. Food and Drug Administration (FDA) in utilizing categorical model predictions in a regulatory setting for drug safety evaluation, since 1998._(Unpublished internal documents, available upon request from the ICSAS office or MultiCASE. See alsoMatthews EJ, Contrera JF. A new highly specific method for predicting the carcinogenic potential of pharmaceuticals in rodents using enhanced MCASE QSAR-ES software. Regul Toxicol Pharmacol 1998; 28(3):242–264.)According to the RCA rules based evaluation which is summarized in the table above, an alert in order to be relevant and confirmed basing on the weight of evidence approach has to appear in a structurally similar form in more than 2 test modules within a test battery.
The RCA reasoning system based on the results of MC4PC generated predictions are routinely used the ICSAS office of CDER FDA for the research and regulatory support activities.
Conclusion:.
It is concluded that the MultiCASE model/RCA weight of evidence approach is valid for prediction of sodium O-ethyl dithiocarbonate’s effect on reproductive toxicity to humans.
Final conclusion is that the tested chemical is considered to be nonthreatening to humans from this evaluation.
Other QSAR predictions:
ACD/Labs
(http://weblab.acdlabs.com/iLab2/index.php)
CEASAR QSAR model for Developmental Toxicity
(http://www.ceasar-project.eu)
QSAR TOOLBOX
(QSAR Toolbox Version 2.2 , Client - Server)
The mentioned above QSAR predictions do not indicate reproductive toxicity of xanthates.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEC
- 622 mg/m³
- Study duration:
- chronic
- Species:
- rat
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
There is no human available information concerning developmental effect for xanthaes.
Reproductive effects of carbon disulfide should be consider because it is a metabolite and decomposition product of xanthates.
Birth defects have been reported in newborns of women workers exposed to carbon disulfide and increased rate of menstrual disorder, toxemia of pregnancy were also reported in case of exposition to 12-18 ppm carbon disulfide.
Decreased sperm count and decreased libido in men and menstrual irregularities in women exposed at the workplace, possible disruptions of the neuro-hormonal-endocrine balance necessary for normal ovarian and uterine cycles may lead to amenorrhea, abnormal menstrual cycles and even to sterility. However, community and workplace studies have not shown a decrease fertility rate , an increase in the time between live births, or an effect on semen quality with carbon disulfide exposure.(“Toxicological Profile for Carbon Disulfide” , U.S. Department of Health and Human Services, Agency for Toxic Substances and Disease Registry, August 2000)
Developmental effect of carbon disulfide (CAS# 75-15-0) have been noticed in the case of women exposed to the chemical at workplace but the data are inadequate to draw any conclusion. Pharmacokinetic studies indicate that carbon disulfide and its metabolites pass the placenta at all stages of gestation and localize in brain, blood, liver, and eyes, but is not identifiable at what level the exposure could produce effects in humans.(“Toxicological Profile for Carbon Disulfide” , U.S. Department of Health and Human Services, Agency for Toxic Substances and Disease Registry, August 2000)
Repeated exposure to carbon disulphide vapour can adversely affect the central and peripheral nervous systems, including weakening of the muscles of the legs and damage to the peripheral and cerebral arteries. Carbon disulphide has been shown to contribute towards coronary heart disease in exposed workers, and severe effects on the retina of the eye have been observed. Hearing defects in workers exposed to carbon disulphide have also been reported. Adverse effects on the reproductive system of workers have been noted, including menstrual abnormalities in females and decreased libido and changes in sperm morphology in males.(Sodium Ethyl
Xanthate PRIORITY EXISTING CHEMICAL NO. 5 MAY 1995 AUSTRALIAN GOVERNMENT PUBLISHING SERVICE
CANBERRA)
Summary and discussion of reproductive toxicity
There is no human information available concerning reproductive toxicity for xanthates(, CHEMINFO ,2004, ,Chemical Profiles Created by CCOHS , www.ccohs.ca).
According to Horst Spielmann(Environmental HealthPerspectives: Vol. 106, Sup.2 April 1998)a direct influence on the developing organism has not only a given chemical but also its active metabolites. Toxicokinetic and metabolism studies are very important for the interpretation of the developmental toxicity.
Carbon disulfide (CAS# 75-15-0) is the main metabolite of xanthates, and it is consider as an active reproductive and developmental toxicant.
Justification for classification or non-classification
Additional information
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.
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