Registration Dossier
Registration Dossier
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EC number: 290-271-3 | CAS number: 90106-48-2 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Secale cereale, Gramineae.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Remarks:
- In vitro acute toxicity test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May-June 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guidance document 129
- Version / remarks:
- July 20th, 2010
- Deviations:
- yes
- Remarks:
- According to the OECD guidance document, hill function analylis was performed by GraphPad PRISM 5.01. The software is not validated which constitutes a deviation from GLP. A polynomial regression by excel confirmed the positive controle dose-response R^2.
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM protocol 139
- Version / remarks:
- DB-ALM 139 protocol and EURL ECVAM Recommendation, April 2013
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- other: 3T3 NRU method
- Limit test:
- no
Test material
- Reference substance name:
- Rye, ext.
- EC Number:
- 290-271-3
- EC Name:
- Rye, ext.
- Cas Number:
- 90106-48-2
- IUPAC Name:
- Oligosaccharides and polysaccharides of glucose from Rye
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: white powder
- Storage In darkness at room temperature
- Batch: 16 167
- Manufacturing date: June 2016
- Expiry date: June 2018
Constituent 1
Test animals
- Species:
- other: N/A
- Strain:
- other: N/A
- Details on test animals or test system and environmental conditions:
- N/A
Administration / exposure
- Route of administration:
- other: N/A
- Vehicle:
- other: N/A
Results and discussion
- Preliminary study:
- Range finding test:
the test item concentration giving 50% cell viability cannot be assessed. Viability is always higher than 50%. The maximal concentration in the main test has been therefore increased to 35 mg/ml.
Effect levels
- Key result
- Dose descriptor:
- LD50
- Effect level:
- ca. 5 181 mg/kg bw
- Based on:
- test mat.
- Mortality:
- N/A
- Clinical signs:
- N/A
- Body weight:
- N/A
- Gross pathology:
- N/A
- Other findings:
- The IC50 for test 1 is > 35 mg/ml, leading to LD50 equal to 5181 mg/kg
The IC50 for test 2 is > 35 mg/ml, leading to LD50 equal to 5181 mg/kg
Any other information on results incl. tables
Interpretation of results:
The test has been evaluated in Acute Tox, an integrated in the EU PF6 project on optimization and prevalidation of an in vitro test for predicting human acute orale toxicity.
The NICEATM/ICCVAM Peer review panel report (2006) has confirmed that the test do not allow to predict each of the GHS acute orale toxicity categories. However the test may be used to determine the starting doses for acute oral in vivo toxicity. ICCVAM Test method evaluation report (2006) therefore proposed a regression model, based on rat acute toxicity data, in order to predict LD50 value from the IC50 value obtained withe the 3T3 NRU method.
The regression models are as follow:
Milimole regression model: log LD50 (mmol/kg) = 0.439 log IC (mM) + 0.621
Weight regression model: log LD50 (mg/kg) = 0.372 log IC (µg/ml) + 2.024
EURL ECVAM Recommendation from April 2013 has confirmed that the 3T3 NRU Cytotoxicity Assay can be used in an integrated strategy to support identification of non-classified substances when using a threshold > 2000 mg/kg. This threshold was used for non-classification by EU CLP.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the retained experimental conditions, the mean LD50 of the test item is equal to 5181 mg/kg, which is higher than 2000 mg/kg. The test item may be not classified for acute toxicity according to CLP classification.
- Executive summary:
Under the retained experimental conditions, the mean LD50 of the test item is equal to 5181 mg/kg, which is higher than 2000 mg/kg. The test item may be not classified for acute toxicity according to CLP classification.
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