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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

Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- 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
- 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
- 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
- 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
- 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
- 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.
- 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: 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.
- 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
- 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
- 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
- Reproductive effects observed:
- not specified
- 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.
Reference
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.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 2 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is from authoritative database
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Studies for reproductive toxicity from reliable sources having Klimisch rating 2 were reviewed
The summary of the results are presented below:
Sr. No |
End point |
Value |
Species |
Route |
Effects |
Remarks |
1. |
NOAEL |
2 mg/ kg bw/ d |
Rat |
Oral: gavage |
No adverse effect on survival, clinical sign, body weight, food consumption, urinalysis, haematology, clinical chemistry, organ weight and histopathology of parents and No effect on viability index, live birth index and number of live pups |
Experimental data for target chemical |
2. |
NOAEL
|
1 mg/ kg bw/ d |
Rat |
Oral: gavage |
No adverse effect on clinical sign, body weight, food consumption, haematology, clinical chemistry, organ weight, gross pathology, histopathology and reproductive effect |
Experimental data for target chemical |
Based on the studies summarized in the above table it can be observed that NOAEL value varies from 1 to 2 mg/Kg bw/ d. in rats. The effects observed on these doses was listed as follows:
· No adverse effect on survival, clinical sign, body weight, food consumption, urinalysis, haematology, clinical chemistry, organ weight and histopathology
· No effect on viability index, live birth index and number of live pups
· No adverse effect on clinical sign, body weight, food consumption, haematology, clinical chemistry, organ weight, gross pathology, histopathology and reproductive effect.
Since highest no effective dose value (NOAEL) is 2 mg/Kg bw/d thus based on this value it can be concluded that substance is considered to be not toxic to reproduction via oral route for the above mentioned dose.
Short description of key information:
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
Justification for selection of Effect on fertility via oral route:
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
Justification for classification or non-classification
On the basis of available information, the substanceThiosemicarbazide is not expected to be reprotoxic in nature.
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.
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