Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-184-7 | CAS number: 79-19-6
- 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:
- one-generation reproductive toxicity
- Remarks:
- based on generations indicated in Effect levels (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Published in authoritative database
Data source
Reference
- Reference Type:
- publication
- Title:
- Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test (OECD TG422)
- Author:
- Hazard-Data Evaluation Committee of National Institute of Technology and Evaluation
- Year:
- 2 015
- Bibliographic source:
- National Institute of Technology and Evaluation (NITE) Chemical Risk Information Platform (CHRIP), updated 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Thiosemicarbazide
- EC Number:
- 201-184-7
- EC Name:
- Thiosemicarbazide
- Cas Number:
- 79-19-6
- Molecular formula:
- CH5N3S
- IUPAC Name:
- hydrazinecarbothioamide
- Reference substance name:
- thiosemicarbazide (Synonym: Hydrazinecarbothioamide)
- IUPAC Name:
- thiosemicarbazide (Synonym: Hydrazinecarbothioamide)
- Test material form:
- solid: crystalline
- Details on test material:
- CAS No: 79-19-6
Chemical Name: thiosemicarbazide (Synonym: Hydrazinecarbothioamide)
Nature of the chemical: Organic
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age at study initiation: 9 weeks old
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Male: 42 days
Female: 42 - 50 days (from 14 days before mating to day 4 of lactation)
Recovery period:
Males, 14 days
Females (satellite), 14 days - Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.4, 2, 10 mg/kg/day
Basis:
- No. of animals per sex per dose:
- Total: 116
0 mg/kg/day: 12 male, 12 female
0.04 mg/kg/day: 12 male, 12 female
2 mg/kg/day: 12 male, 12 female
10 mg/kg/day: 12 male, 12 female
For recovery group
0 mg/kg/day: 5 male
10 mg/kg/day: 5 male
Satellite group:
0 mg/kg/day: 5 female
10 mg/kg/day: 5 female - Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- Cage side observations to observe for mortality
- Oestrous cyclicity (parental animals):
- Any irregularity in Estrous cyclicity were observed
Implantations, gestation length and parturition were observed in female rats . - Litter observations:
- Survival number of offspring or live
offspring at birth, sex ratio, clinical signs, external features and body weights were examined. - Postmortem examinations (parental animals):
- Organ weight:
Absolute and relative Liver, kidney and thymus weight were recorded.
Gross pathology: Yes,
Female rats were observed for numbers of corpora lutea or
Implantations were examined.
HISTOPATHOLOGY: Yes - Postmortem examinations (offspring):
- Postmortem examinations (offspring)
SACRIFICE: yes, Offspring, On day 4 after birth
GROSS NECROPSY: Yes
Gross abnormalities were examined.
HISTOPATHOLOGY / ORGAN WEIGTHS: Yes - Reproductive indices:
- Copulation index, fertility index, delivery index, implantation index and gestation index were examined.
- Offspring viability indices:
- Viability on day 4 were observed.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- One female rat died at 10 mg/kg/day dose group as compared to control. Tonic convulsion in male and female rats and excessive response to touch or tail pinch were observed in male rats at 10 mg/kg/day dose group as compared to control
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Decrease tendency in the body weight and body weight gain was comparable to that of the control group from day 15 onwards were observed in treatment and recovery at 10 mg/kg/day dose group as compared to control.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Decrease tendency in the body weight and body weight gain was comparable to that of the control group from day 15 onwards were observed in treatment and recovery at 10 mg/kg/day dose group as compared to control.
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Atrophy of the thymus in male rat and Pulmonary edama, increase in the karyorrhexis in the white pulp of the spleen, mandibular lymph node and mesenteric lymph node in dead female rats were observed in 10 mg/kg/day
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, treatment-related
- Description (incidence and severity):
- No effect were observed on estrous cycle, copulation index, fertility index, delivery index, gestation length, numbers of corpora lutea or implantations, implantation index, gestation index, parturition and maternal behavior of treated female rats
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- Decrease in live birth index were observed in 10 mg/kg/day treeated female rats as compared to control.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 2 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effect on survival, clinical sign, body weight, food consumption, urinalysis, hematology, clinical chemistry, organ weight and histopathology
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Decreased in number of live offspring and viability on day 4 were observed at 10 mg/kg/day dose group as compared to control.
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- Decreased in number of live offspring and viability on day 4 were observed at 10 mg/kg/day dose group as compared to control.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- No changes were observed in body weight
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Jaundice was observed in 1 offspring each at 2 and 10 mg/kg/day. However, the relation to the test substance was not clear, since no similar changes were noted in any other offspring
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 2 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on viability index, live birth index and number of live pups
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Food consumption:
No effect was observed on food consumption of treated rats as compared to control.
Haematology:
No effect was observed on blood hematology of treated rats as compared to control.
Clinical chemistry:
Increase in total cholesterol level was observed in male rats in 10 mg/kg/day as compared to control.
Urinanalysis:
No effect was observed on urinanalysis of treated rats as compared to control.
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 2 mg/kg/day for F0 and F1 generation when Crj: CD (SD) male and female rats treated with Hydrazinecarbothioamide
- Executive summary:
In a Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test (OECD TG422) was conducted. Crj:CD (SD) male and female rats were dosed orally at concentration 0, 0.4, 2, 10 mg/kg/day for 42days (male rats) & 42-50 days (Female-from 14 days before mating to day 4 of lactation). In F0 generation,No effects were observed on food consumption, urinalysis and hematology of treated rats. One female rat died,Tonic convulsion in male and female rat and Excessive response to touch or tail pinch were observed in male rat and Decrease tendency in the body weight were observed in treatment and recovery at10 mg/kg/day dose group trreated rats as compared to control. Similarly,Increase in total cholesterol level and Increase absolute and relative liver and kidney weight and Decrease in absolute and relativethymus weight were observed in male rats at 10 mg/kg/day does group as compared to control. Decrease in absolute and relativethymus weight was observed in male rats at 2 mg/kg/day does group. In addition, Atrophy of the thymus in male rat and Pulmonary edama, Increase in the karyorrhexis in the white pulp of the spleen, mandibular lymph node and mesenteric lymph node in dead female rats were observed in 10 mg/kg/day does group as compared to control.Decrease in live birth index were observed in 10 mg/kg/day treeated female rats as compared to control. In F1 generation, Decreased in number of live offspring and viability on day 4 were observed at 10 mg/kg/day dose group as compared to control. Therefore, NOAEL was considered to be 2 mg/kg/day for F0 and F1 generation when Crj: CD (SD) male and female rats treated with Hydrazinecarbothioamide. orally by gavage.
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.