Registration Dossier
Registration Dossier
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EC number: 210-719-3 | CAS number: 622-08-2
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline available
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- Not Specified
- No. of animals per sex per dose:
- Not Specified
- Control animals:
- not specified
- Details on study design:
- Not Specified
- Statistics:
- Not Specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 190 mg/kg bw
- Clinical signs:
- BEHAVIORAL: General anesthetic
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Acute Oral LD50 value of 1190 mg/kg bw was determined in a study with limited reliability. In this regard, No details on the study are available. However, The identified value allowed to allocate the substance in the category 4 following GHS Criteria (300 mg/kg bw
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- The substance is only used as active ingredient for cosmetic products. The acute toxicity endpoint (oral route) has been assessed using a weight of evidence approach, avoiding the use of animals for in vivo tests. -In vitro acute toxicity test:: 3T3 NRU cytotoxicity assay oaccording to the OECD guidance document nº 129, the ECVAM OB-ALM nº139 protocol and the EURL ECVAM Recommendation, April 2013
- Qualifier:
- according to guideline
- Guideline:
- other: eries on testing and assessment n°129 , DB-ALM Protocol n°139
- Deviations:
- no
- Principles of method if other than guideline:
- The cytotoxicity assay performed in this study was designed to evaluate the cytoxiic potential of the test item solubilised in the medium culture for 48h towards the fibroblasts cell line BALB/ 3T3 clone A31 (ATCC-CCL-163). After 48h of incubation with different concentrations of the test item with fibroblasts, viability cell is determed by NRU test.
The IC50 value is used in linear regression equation to estimate the oral LD50 value. - GLP compliance:
- yes
- Test type:
- other: in vitro
- Key result
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 432.63 other: mg/Kg
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The test item cannot be classified ad no toxic.
- Executive summary:
The substance is only used as active ingredient for cosmetic products. The acute toxicity endpoint (oral route) has been assessed using a weight of evidence approach, avoiding the use of animals for in vivo tests. -In vitro acute toxicity test:: 3T3 NRU cytotoxicity assay oaccording to the OECD guidance document nº 129, the ECVAM OB-ALM nº139 protocol and the EURL ECVAM Recommendation, April 2013.
Referenceopen allclose all
The test item tested on Balb/3T3 cells showed an IC50 mean value of 1105 mcg/ml, equivalent to an estimated LD50 value of 1432.65 mg/Kg. The test item was tested in two different main tests with 8 different concentrations (10.000; 4651.16; 2163.33; 1006.20; 468.00; 217.67; 101.24; 47.09 mcg/ml). All acceptance criteria were passed.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 190 ng/kg bw
Additional information
Justification for classification or non-classification
The substance is only used as active ingredient for cosmetic products. The acute toxicity endpoint (oral route) has been assessed using :
- a weight of evidence approach, avoiding the use of animals for in vivo tests. -In vitro acute toxicity test:: 3T3 NRU cytotoxicity assay oaccording to the OECD guidance document nº 129, the ECVAM OB-ALM nº139 protocol and the EURL ECVAM Recommendation, April 2013
- supporting study (literature)
The identified values allowed to classify the substance in the category 4 following GHS Criteria (300 mg/kg bw<LD50<2000 mg/kg bw)
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