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Description of key information

Weight of evidence: According the several handbooks and the well documented publications the test item has the following LD values: LD50 oral value of 9.2 mg/kg/ for rats (Enviromental data on Organic chemicals) and 13 mg/kg/bw for rats (Merck Index). The ALD of 94 mg/kg for deer mouse (Archives of Environmental Contamination and Toxicology) and LD100 of 20 mg/kg for mice (Sage Journal). The LD50 of 10 mg/kg/bw for dog, LD50 of 20 mg/kg/bw for cat and LD50 of 94 mg/kg/bw for mouse were evaluated according the handbook of Envirnmental data on organic chemicals. In the summary, the different LD50 values are between 9.2 - 20 mg/kg for species (rats,mouse, cat and dog).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Principles of method if other than guideline:
Data from handbook
GLP compliance:
not specified
Remarks:
Handbook data
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 9.2 mg/kg bw
Based on:
not specified
Interpretation of results:
Category 2 based on GHS criteria
Conclusions:
The test item has an LD50 oral value of 9.2 mg/kg/bw for rats.
Executive summary:

According the handbook of Enviromental data on Organic chemicals, the test item has an LD50 oral value of 9.2 mg/kg/bw for rats.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Principles of method if other than guideline:
Data from handbook
GLP compliance:
not specified
Remarks:
Handbook data
Species:
rat
Strain:
Brown Norway
Sex:
not specified
Route of administration:
oral: unspecified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 13 mg/kg bw
Based on:
not specified
Interpretation of results:
Category 2 based on GHS criteria
Conclusions:
The test item has an LD50 oral value of 13 mg/kg/bw for rat.
Executive summary:

According the Merck index, the test item has an LD50 oral value of 13 mg/kg/bw for rat.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
No data on method. No data on GLP.
Qualifier:
no guideline followed
Principles of method if other than guideline:
In the present publication of Archives of Environmental Contamination and Toxicology, 6 animals (20 g) were used. Animals were administrated in gradualy dosage scale by gavage using water, corn oil, or 1.0% carbopol as carriers, followed by 3-days of observations for mortality.
GLP compliance:
not specified
Test type:
other: Not specified
Species:
mouse
Strain:
other: Deer mice
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 20 g
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Corn oil, or 1.0% carbopol as carriers
Details on oral exposure:
DOSAGE PREPARATION (if unusual) :Graduated dosage scale.

MAXIMUM DOSE VOLUME APPLIED: Using this single animal per level method, each succeeding treatment was 50% higher than the preceding level and continued until mortality occurred.
No. of animals per sex per dose:
6 animals

Control animals:
not specified
Details on study design:
- Duration of observation period following administration: Three days of observation for mortality.
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: No specified
Statistics:
The final set of toxicity data was derived from the FR value, the known average weight of individual wheat seeds (50 mg) and the known average weight of each individual deer mouse (20 gm). This calculated value LDfr represented the average amount of chemical, in mg/kg/ day, that was ingested by each animal over the 3-day test period without killing more than 50% of the test animals.
Key result
Sex:
not specified
Dose descriptor:
other: ALD
Effect level:
ca. 94 mg/kg bw
Based on:
not specified
Key result
Sex:
not specified
Dose descriptor:
other: LDfr
Effect level:
ca. 317 mg/kg bw
Based on:
not specified
Remarks on result:
other: Amount of test substance ingested during the FR test which killed or did not kill more than 50% of the test mice
Mortality:
Not specified
Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The test item has an acute oral ALD (approximate lethal dose) value of 94 mg/kg to deer mice and the LDfr value was evaluated as 371 mg/kg/day .
Executive summary:

According the present publication,test item was tested for acute oral toxicity to deer mice. Based on the data from repellency test, the food reduction value, FR value, of thiosemicarbazide was evaluated between 74.7-88.0 %. In the test for acute oral toxicity, 6 animals were used. Animals were administrated by gavage using water, corn oil or 1.0 carbopol, followed by 3 days of observations for mortality.The result value of the acute oral toxicity approximate lethal dose ALD is 94 mg/kg and LDfr was evaluated as 317 mg/kg/bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
No data on method. No data on GLP.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
not specified
Species:
mouse
Strain:
C57BL
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 18-20 g
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1 ml
Doses were administrated by a syringe with an attached blunted, curved 15-gauge hypodermic needle which was introduced into the esophagus

Control animals:
not specified
Details on study design:
- Frequency of observations and weighing: Closely 4 hours and again at 12- and 24-hour intervals
Key result
Sex:
not specified
Dose descriptor:
LD100
Effect level:
ca. 20 mg/kg bw
Based on:
not specified
Mortality:
Yes - in all animals tested. The great majority of deaths occurred within the first 4 hours.
Interpretation of results:
study cannot be used for classification
Conclusions:
The test item caused fatal convulsions in the dose 20mg/kg/bw.
Executive summary:

According the present study test item was tested for acute oral toxicity in black mice. Animals were observed closely for 4 hours and again at 12 and 24 hour interval.The majority of death occurred within first 4 hours. As the fatal convulsion occurred in all tested animals (810), the LD100 of 20 mg/kg/bw was evaluated.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Principles of method if other than guideline:
Data from handbook
GLP compliance:
not specified
Remarks:
Handbook data
Species:
cat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 20 mg/kg bw
Based on:
not specified
Interpretation of results:
study cannot be used for classification
Conclusions:
The test item has an LD50 oral value of 20 mg/kg/bw for cats.
Executive summary:

According the handbook of Enviromental data on Organic chemicals, the test item has an LD50 oral value of 20 mg/kg/bw for cats.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Principles of method if other than guideline:
Data from handbook
GLP compliance:
not specified
Remarks:
Handbook data
Species:
dog
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 10 mg/kg bw
Based on:
not specified
Interpretation of results:
study cannot be used for classification
Conclusions:
The test item has an LD50 oral of 10mg/kg/bw for dog.
Executive summary:

According the handbook of Enviromental data on Organic chemicals, the test item has an LD50 oral value of 10mg/kg/bw for dog.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
9.2 mg/kg bw
Quality of whole database:
Diverse oral-DL50 from handbooks and publications are taken as a weight of evidence. The results of the whole database lead to the same classification of the substance according to CLP regulation, the oral-LD50 is in accordance with the doses used in repeated dose toxicity studies.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Weight of evidence: Several secondary source and publications of Klimisch 3 and 4 (no data on the method) is available for Thiosemicarbazide. This results range from 9.2-20 mg/kg bw in different species (mouse, rat, cat dog). The most sensitive specie seems to be the rat with a LD50 of 9.2 mg/kg. This information leads to the classification of the substance as Acute oral toxicity Category 2, H302 according to CLP Regulation (EC) no. 1272/2008.

Justification for classification or non-classification

Based on the available data, the test item Thiosemicarbazide is classified according to CLP Regulation (EC) no. 1272/2008 as acutely toxic, Category 2 according the Lethal dose LD50 of 9.2 mg/kg/bw rat.