Registration Dossier
Registration Dossier
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EC number: 607-097-4 | CAS number: 225234-14-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- September 2, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: HET-CAM test
- Version / remarks:
- The test is a modification of that described by Kemper and Luepke (1986, FD Chem. Toxic. 24, p.495-496).
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fats and Glyceridic oils, shea butter, unsaponifiable fraction
- EC Number:
- 607-097-4
- Cas Number:
- 225234-14-0
- Molecular formula:
- UVCB substance
- IUPAC Name:
- Fats and Glyceridic oils, shea butter, unsaponifiable fraction
Constituent 1
- Specific details on test material used for the study:
- Lipex Shea Tris, 50% in Akosun Batch P10-16-2-A
Test animals / tissue source
- Species:
- other: chick embryo
- Strain:
- other: White Leghorn eggs
Test system
- Vehicle:
- physiological saline
- Controls:
- yes
- Amount / concentration applied:
- 0.3 ml or 0.3 g.
- Duration of treatment / exposure:
- 2 and 5 mins
- Duration of post- treatment incubation (in vitro):
- 30 seconds,2 and 5 minutes
- Number of animals or in vitro replicates:
- 4 CAMs
- Details on study design:
- Please see the attached study report.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: Hyperemia
- Value:
- >= 1 - <= 5
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Minimal hemorrhage (feathering)
- Value:
- >= 3 - < 7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Remarks on result:
- no indication of irritation
- Remarks:
- slight irritation first but then disappeared
- Irritation parameter:
- other: Hemorrhage (obvious leakage)
- Value:
- >= 5 - <= 9
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Coagulation and/or thrombosis)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, the results indicated that Lipex Shea Tris, 50% in Akosun Batch P10-16-2-A, at twice the submitted concentration, would have practically no ocular irritation potential in ex vivo.
- Executive summary:
Under the conditions of this test, the results indicated that Lipex Shea Tris, 50% in Akosun Batch P10-16-2-A, at twice the submitted concentration, would have practically no ocular irritation potential in ex vivo.
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