Registration Dossier
Registration Dossier
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EC number: 252-106-3 | CAS number: 34592-47-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- (R)-thiazolidine-4-carboxylic acid
- EC Number:
- 252-106-3
- EC Name:
- (R)-thiazolidine-4-carboxylic acid
- Cas Number:
- 34592-47-7
- Molecular formula:
- C4H7NO2S
- IUPAC Name:
- (R)-thiazolidine-4-carboxylic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- CMC (carboxymethyl cellulose)
- Doses:
- A single oral administration (10 mL/kg in 0.5% aqueous solution of carboxymethylcellulose)
to the Sprague Dawley rat followed by a 14-day observation period. - No. of animals per sex per dose:
- 1 female in the sighting study, further 4 females in the main study.
Results and discussion
- Preliminary study:
- A single female animal was dosed at 300 mg/kg.
No mortality occurred during the study. Convulsions, ataxia, decreased activity, hunched
posture, piloerection and brown staining on the muzzle were observed on the day of dosing.
No clinical signs were seen from Day 2 up to the and of the study.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality.
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- The body weight changes observed in the animals were not remarkable with the exception of body weight loss observed in a single animal showing signs that could be unrelated to the toxicity of the test item
- Gross pathology:
- No abnormalities were observed at the necropsy examination performed on termination of
the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- These results indicate that the test item, L(-)-Thiazolidine-4-carboxylic acid (TCA), has some toxic effect (clinical signs) on the rat following oral administration of single doses of
300 mg/kg, quickly reversible, but no mortality occurred.
European Directives concerning the classification, packaging and labelling of dangerous
substances (Council Regulation (EC)No. 1272/2008 and subsequent revisions) would indic-
ate the following:
Classification Category 4
Signal word Warning
Hazard statement H302: Harmful if swallowed
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