Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Final Report on the Safety Assessment of Hydrolyzed Collagen
- Year:
- 1 985
- Bibliographic source:
- JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY, Vol. 4, No 5, 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Principles of method if other than guideline:
- Draize method involve the instillation of 0,1 ml of a test liquid into the lower conjunctival cul-de-sac. Observations of various criteria (i.e., corneal opacity and area of corneal involvement, conjunctival hyperemia, chemosis, ocular discharges, and iris abnormalities) are taken at pre-defined intervals: 1, 24, 48, and 72 hours, and 1 week, after administration. Eyes were scored by Draize classification (max, 110) at 1, 2, 3, 4, and 7 days or until negative.
- GLP compliance:
- not specified
- Remarks:
- tests were performed in 1973
Test material
- Reference substance name:
- Hydrolyzed Collagen
- IUPAC Name:
- Hydrolyzed Collagen
Constituent 1
- Specific details on test material used for the study:
- 50% solution tested
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino white
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 50% solution.
- Observation period (in vivo):
- 7 days or until negative
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- 50% solution
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- 50% solution
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Hydrolyzed Collagen was concluded to be minimally irritating
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to eyes
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