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EC number: 225-713-6 | CAS number: 5025-82-1
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- 3-acetylthiazolidine-4-carboxylic acid
- EC Number:
- 225-713-6
- EC Name:
- 3-acetylthiazolidine-4-carboxylic acid
- Cas Number:
- 5025-82-1
- Molecular formula:
- C6H9NO3S
- IUPAC Name:
- 3-acetylthiazolidine-4-carboxylic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Doses:
- Dose-range Finding Study
The purpose of the dose-range finding study is selection of the appropriate starting dose for the main study. The starting dose could be selected from the fixed dose levels of 50, 200, 1000, and 2000 mg/kg body weight.
The test item information was available, a limit dose of 2000 mg/kg body weight was used as starting dose. One female was dosed. The test item-related mortality was not observed during 48 hours. The dose-range finding study was finished; the main test was started with dose of 2000 mg/kg body weight.
Main Study
Based on the outcome in the dose-range finding study, the main study was conducted with 2 further animals to confirm the classification outcome. The additional 2 females were dosed with the dose of 2000 mg/kg body weight. A total of three female rats were dosed with a limit dose of 2000 mg/kg body weight. - No. of animals per sex per dose:
- 3 females, animals were non-pregnant and nulliparous.
- Details on study design:
- Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk of the test animals by clipping and shaving.
The required amount of the test item (according to the body weight and dose) moistened with the vehicle (0.5 mL) was applied directly on the shaved skin of the back uniformly on an area approximately 10 % of a total body surface area. The test item was held in contact with the skin by using semi-occlusive dressing with non-irritating tape throughout the 24-hours exposure period. At the end of the exposure period, any residuals of the test item were removed by using lukewarm water.
Results and discussion
- Preliminary study:
- All, 3/3 females survived the limit dose of 2000 mg/kg body weight. Summary results of clinical observation are presented in Table 2. On day 3 and 4 (48 and 72 hours after dressing removing), the very slight redness of skin at the application site was found in the animal No. 2 treated with a 2000 mg/kg body weight dose as pale pink spot assigned as erythema of score 1.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Body weight:
- other body weight observations
- Remarks:
- Mildly increase of the body weight of animals was observed.
Any other information on results incl. tables
RESULTS
1 Clinical Observation
All, 3/3 females survived the limit dose of 2000 mg/kg body weight. Summary results of clinical observation are presented in Table 2. On day 3 and 4 (48 and 72 hours after dressing removing), the very slight redness of skin at the application site was found in the animal No. 2 treated with a 2000 mg/kg body weight dose as pale pink spot assigned as erythema of score 1. Observation results of the treatment skin 24, 48 and 72 hours after removal of the test item are presented in Table 3.
Table 2 Clinical Observation
Sex | Dose | ID | Administration Result | Clinical Observation |
♀ | 2000 mg/kg | 1 | alive | no signs of intoxication, change of health, nor any adverse reactions during 14-days observation period |
2 | alive | no signs of intoxication, change of health, nor any adverse reactions during 14-days observation period | ||
3 | alive | no signs of intoxication, change of health, nor any adverse reactions during 14-days observation period |
Table 3 Skin Reaction Score
Sex | Dose | ID | 24 hours | 48 hours | 72 hours | |||
Erythema | Oedema | Erythema | Oedema | Erythema | Oedema | |||
♀ | 2000 mg/kg | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 1 | 0 | 1 | 0 | ||
3 | 0 | 0 | 0 | 0 | 0 | 0 |
ID 2 – 96 hours after dressing removing without erythema
2 Body Weight
Mildly increase of the body weight of animals was observed. Summary results of body weight development are presented in Table 4.
Sex | Dose | ID | Body Weight (g) | Body Weight Difference (g) | ||||
Initial | Week 1 | Week 2 | Week 1 - Initial | Week 2 - Initial | Week 2 - Week 1 | |||
♀ | 2000 mg/kg | 1 | 201 | 201 | 209 | 0 | 8 | 8 |
2 | 191 | 200 | 217 | 9 | 26 | 17 | ||
3 | 186 | 194 | 205 | 8 | 19 | 11 |
3 Necropsy
All animals were necropsied. During necropsy, no macroscopic changes were noticed. Necropsy results are presented in Table 5.
Table 5 Necropsy Results
Sex | Dose | ID | Result |
♀ | 2000 mg/kg | 1 | no finding |
2 | no finding | ||
3 | no finding |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 of the test item 3-Acetylthiazolidine-4-carboxilyc acid, synonym Folcisteine is greater than 2000 mg/kg body weight after single dermal application to Wistar rats.
Based on OECD Test Guideline 402 Acute Dermal Toxicity: Fixed Dose Procedure it can be concluded that the test item 3-Acetylthiazolidine-4-carboxilyc acid, synonym Folcisteine according to the Globally Harmonised System can be classified in Category 5/Unclassified after single dermal application to Wistar rats. - Executive summary:
The purpose of the study was to evaluate the potential toxic effect of the test item 3-Acetylthiazolidine-4-carboxilyc acid, synonym Folcisteine when applied as a single dermal dose to Wistar rats. The procedure according to OECD Test Guideline 402 Acute Dermal Toxicity: Fixed Dose Procedure was used.
Test item information were available, a limit dose of 2000 mg/kg body weight was used as starting dose. One female was dosed. Test item-related mortality was not observed during 48 hours. Based on the outcome in the dose-range finding study, the main study was conducted with 2 further animals to confirm the classification outcome. A total of three female rats were dosed with a limit dose of 2000 mg/kg body weight.
The test item 3-Acetylthiazolidine-4-carboxilyc acid, synonym Folcisteine applied to 3 females at a limit dose of 2000 mg/kg body weight did not cause death. Mildly increase of the body weight of animals was observed. No signs of intoxication, change of health, nor any other adverse reactions during 14-days observation period was observed. The test item did cause very slight erythema on the skin of one test animal. Erythema disappeared within 96 hours after dressing removing. During necropsy, no macroscopic findings were observed.
The LD50 of the test item 3-Acetylthiazolidine-4-carboxilyc acid, synonym Folcisteine is greater than 2000 mg/kg body weight after single dermal application to Wistar rats.
Based on OECD Test Guideline 402 Acute Dermal Toxicity: Fixed Dose Procedure it can be concluded that the test item 3-Acetylthiazolidine-4-carboxilyc acid, synonym Folcisteine according to the Globally Harmonised System can be classified in Category 5/Unclassified after single dermal application to Wistar rats.
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