Registration Dossier
Registration Dossier
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EC number: 701-347-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: Read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- Justification for Read Across is given in Section 13 of IUCLID.
Data source
Reference
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of Oleic Acid, Lauric Acid, Palmitic Acid, Myristic Acid and Stearic Acid
- Author:
- Libert M.A.
- Year:
- 1 987
- Bibliographic source:
- Journal of the American College of Toxicology
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- The test item was administered to the eyes of six albino rabbits. 0.1 mL of test item was instilled into one eye of each test animals (untreated eye was used as control). The treated eyes were not rinsed after the application of the test item. Effects to the cornea, iris and conjunctivae were observed up to 72 hrs.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- SS03_PS/Ketoacids
- IUPAC Name:
- SS03_PS/Ketoacids
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino rabbits
- Details on test animals or tissues and environmental conditions:
- Not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL of the commercially grade test item.
- Observation period (in vivo):
- 72 hrs
- Number of animals or in vitro replicates:
- 6 animals
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Time point:
- 72 h
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not eye irritant according to CLP Regulation (EC) 1272/2008
- Conclusions:
- Administration of commercial grade test item to the eyes of 6 albino rabbits produced no irritation.
- Executive summary:
The eye irritation potential of the test item was studied in an in vivo test on albino rabbits. 0.1 mL of the test item (commercially grade) was administered to the eye of six albino rabbits (untreated eye was used as control). The treated eyes were not rinsed after the application of the test item. No sign of irritation were observed after the application of the test item, so it was considered as non irritant.
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