Thiosemicarbazide

Skin irritation / corrosion

Administrative data

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

Data source

Reference

Reference Type:

other: Authoritative database

Title:

Skin irritation study on rats

Author:

US National Library of Medicine (NLM)

Year:

2015

Bibliographic source:

Canadian Centre for Occupational Health and Chemistry

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Thiosemicarbazide

EC Number:

201-184-7

EC Name:

Thiosemicarbazide

Cas Number:

79-19-6

Molecular formula:

CH5N3S

IUPAC Name:

hydrazinecarbothioamide

Details on test material:

- Name of test material (as cited in study report): Thiosemicarbazide
- Molecular formula (if other than submission substance): CH5N3S
- Molecular weight (if other than submission substance): 91.1375 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

rat

Strain:

other: CD

Details on test animals or test system and environmental conditions:

Sex: Male

Test system

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

Results and discussion

In vivo

Results

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.

Applicant's summary and conclusion

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.