Registration Dossier
Registration Dossier
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EC number: 282-001-8 | CAS number: 84082-55-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Lupinus albus, Leguminosae.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20-21 January 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Remarks:
- Study performed according to French offical method published in December 1999 in National register N° 302, and Good Laboratory Practice
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appendix VI of the French National Register N°302 of December, 1999
- Deviations:
- not specified
- Principles of method if other than guideline:
- This test is an alternative method which aims to assess a test item eye irritant potential,. The principle is based on the test item cytotoxicity assessment by determination of the concentration which leads to 50% of cells death (IC50) on a cell monolayer, using the Neutral Red Uptake Method.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Lupine, L. albus, ext.
- EC Number:
- 282-001-8
- EC Name:
- Lupine, L. albus, ext.
- Cas Number:
- 84082-55-3
- IUPAC Name:
- Enzymatic hydrolysis products of Lupinus Albus, Fabaceae, seed
- Test material form:
- liquid
- Details on test material:
- Color Amber
Batch: 09 077 21
Storage conditions: room temperature
Expiry date: 18 September 2010
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Rabbit cornea fibroblasts: SIRC line (ATCC CCL60)
- Details on test animals or tissues and environmental conditions:
- Rabbit cornea fibroblasts: SIRC line (ATCC CCL60)
Test system
- Vehicle:
- other: physiological serum or cottonseed oil
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- Dilution at 25% and 50% of the test material are used.
- Duration of treatment / exposure:
- contact with the test item = 60 secondes
- Observation period (in vivo):
- Not applicable
- Duration of post- treatment incubation (in vitro):
- Not specified
- Number of animals or in vitro replicates:
- Each sample and positive control are tested on three cultures wells by assessed concentration. Negative control is tested on three culture wells per plate.,
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: Percentage of mortality observed at the 50% dilution
- Value:
- 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Estimated IC 50 (%)
- Value:
- > 50
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
Any other information on results incl. tables
| Substance tested | Dose (%) | mean percent of cells mortality |
| SDS | 0.2% | 85 |
| SDS | 0.05% | 39 |
| SDS | 0.01% | 20 |
| test item | 25% | 10 |
| test item | 50% | 3 |
Applicant's summary and conclusion
- Interpretation of results:
- other: insignificant toxicity
- Remarks:
- according to table of French national register N°302, December 1999
- Conclusions:
- The cytotoxicity of tested material is insignificant.
IC 50 is greater to 50% and the percentage of mortality observed at the dilution 50% is 3%.
Under the retained experimental conditions, the cytotoxicity of the tes item may be classified as insignificant cytotoxicity according to the adopted scale - Executive summary:
An in vitro eye irritation study was performed on rabbit cornea fibroblasts according to French national Method published in December 1999 in National register N° 302. The principle of the method is based on assessing the cytotoxicity of the product tested by identifying the concentration causing 50% mortality (IC50) using the technique of neutral red release.
Positivie and Negative (vehicle) controls were used.
The IC50 was up to 50% and the percentage of mortality at the dilution 50% was 3%.
According to this method the cytotoxicity is considered as insignificant.
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