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Diss Factsheets

Administrative data

Description of key information

Thiosemicarbazide is not irritating to the skin of male CD rats and to the eyes of New Zealand White rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from authoritative database
Qualifier:
according to guideline
Guideline:
other: Draize method
Principles of method if other than guideline:
Range finding study was conducted to evaluate the skin irritation potential of the test compound Thiosemicarbazide
GLP compliance:
not specified
Species:
rat
Strain:
other: CD
Details on test animals or test system and environmental conditions:
Sex: Male
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
physiological saline
Remarks:
0.85% saline, 1:1
Controls:
not specified
Amount / concentration applied:
0, 20, and 200 mg/kg
Duration of treatment / exposure:
24 hrs
Observation period:
14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: No data available
- % coverage: No data available
- Type of wrap if used: No data available

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: No data available

SCORING SYSTEM: No data available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 14 days
Reversibility:
no data
Remarks on result:
other: Dermal irritation not observed
Other effects:
Mortality was observed on day 1 of 14 day post treatment and 1 on the day of treatment
Convulsions, tremors, salivation, aggressiveness, and red stained muzzle were observed in the decedent rats. Terminal necropsy disclosed wet and/or tan or red-stained muzzles and darkened livers.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Thiosemicarbazide is not irritating to the skin of male CD rats.
Executive summary:

Thiosemicarbazide was evaluated in range-finding study for acute dermal toxicity in male CD rats administered single occluded dermal applications (0.85% saline, 1:1) of 0, 20, and 200 mg/kg for 24 hours.

 

Dermal exposure was associated with mortality in 5/6 high dose rats only, 4 on Day 1 of 14-day post-treatment observation and 1 on the day of treatment. Prior to death, the decedent rats unanimously exhibited convulsions, tremors, salivation, aggressiveness, and red stained muzzle. Terminal necropsy disclosed wet and/or tan or red-stained muzzles and darkened livers. No apparent toxicity was reported among the solitary surviving rat of a 200 mg/kg application or rats of a 20 mg/kg dose, and no dermal irritation (Draize) was noted in any treated animal.

 

Thiosemicarbazide is not irritating to the skin of male CD rats.

 

In accordance with the CLP classification, the test material Thiosemicarbazide does not classify as a skin irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from authoritative database
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Range finding study was conducted to evaluate the eye irritation potential of the test compound Thiosemicarbazide
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Sex: Male
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
Duration of treatment: 7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): ): 20- 30 sec after the exposure in 3/6 male rabbits
- Time after start of exposure:

SCORING SYSTEM: Ocular irritation of cornea, iris, conjunctivae

TOOL USED TO ASSESS SCORE: No data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Reversibility:
not specified
Remarks on result:
other: No ocular irritation (Draize) of cornea, iris, or conjunctivae was observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Thiosemicarbazide is not irritating to the eyes of New Zealand White rabbits.
Executive summary:

Eye irritation study was performed male New Zealand White rabbits to evaluate the irritation potential of the test compound Thiosemicarbazide.

 

The test chemical was instilled as a single dose of 0.1g in the eyes of rabbits. Half (3/6) of the eyes were cleansed at 20-30 seconds after the exposure.

 

No ocular irritation (Draize) of cornea, iris, or conjunctivae was reported in any animal throughout 7-day post-instillation observation.

 

Thiosemicarbazide is not irritating to the eyes of New Zealand White rabbits.

 

In accordance with the CLP classification, the test material Thiosemicarbazide does not classify as an eye irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation:

Thiosemicarbazide was evaluated in range-finding study for acute dermal toxicity in male CD rats administered single occluded dermal applications (0.85% saline, 1:1) of 0, 20, and 200 mg/kg for 24 hours.

 

Dermal exposure was associated with mortality in 5/6 high dose rats only, 4 on Day 1 of 14-day post-treatment observation and 1 on the day of treatment. Prior to death, the decedent rats unanimously exhibited convulsions, tremors, salivation, aggressiveness, and red stained muzzle. Terminal necropsy disclosed wet and/or tan or red-stained muzzles and darkened livers. No apparent toxicity was reported among the solitary surviving rat of a 200 mg/kg application or rats of a 20 mg/kg dose, and no dermal irritation (Draize) was noted in any treated animal.

 

Thiosemicarbazide is not irritating to the skin of male CD rats.

 

In accordance with the CLP classification, the test material Thiosemicarbazide does not classify as a skin irritant.

Eye irritation:

Eye irritation study was performed male New Zealand White rabbits to evaluate the irritation potential of the test compoundThiosemicarbazide.

 

The test chemical was instilled as a single dose of 0.1g in the eyes of rabbits. Half (3/6) of the eyes were cleansed at 20-30 seconds after the exposure.

 

No ocular irritation (Draize) of cornea, iris, or conjunctivae was reported in any animal throughout 7-day post-instillation observation. Thiosemicarbazide is not irritating to the eyes of New Zealand White rabbits.

 

In accordance with the CLP classification, the test material Thiosemicarbazide does not classify as an eye irritant.

Justification for selection of skin irritation / corrosion endpoint:
Thiosemicarbazide is not irritating to the skin of male CD rats.

Justification for selection of eye irritation endpoint:
Thiosemicarbazide is not irritating to the eyes of New Zealand White rabbits.

Justification for classification or non-classification