Registration Dossier
Registration Dossier
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EC number: 289-998-9 | CAS number: 90063-40-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Ervum lens, Leguminosae.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: Weight of Evidence
- Adequacy of study:
- weight of evidence
- 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 Weight of Evidence argumentation is justified in the attached justification
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 432, OECD 129, ECVAM 139
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Lentil, ext.
- EC Number:
- 289-998-9
- EC Name:
- Lentil, ext.
- Cas Number:
- 90063-40-4
- IUPAC Name:
- Enzymatic hydrolysis products of Lentil extract
- Test material form:
- liquid
- Remarks:
- clear yellow
- Details on test material:
- Batch : 08 295 1
Constituents:
Lens esculenta (Lentil) Seed extract : 4.2% - 6.2%
Others:
Water (solvent): 93.03% - 95.17%
Phenoxyethanol (preservative): 0.45% - 0.55%
Ethylhexylglycerin (stabilisant) : 0.18% - 0.22%
Constituent 1
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the weight of evidence approach, the applicant concludes that the substance "Enzymatic hydrolysis products from Lentil extract" do not show acute oral systemic toxicity potentially up to 2000 mg/kg bw.
Therefore, no classification for acute oral toxicity is needed. - Executive summary:
Based on the weight of evidence approach, the applicant concludes that the substance "Enzymatic hydrolysis products from Lentil extract" do not show acute oral systemic toxicity potentially up to 2000 mg/kg bw.
Therefore, no classification for acute oral toxicity is needed.
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