Registration Dossier
Registration Dossier
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EC number: 300-338-1 | CAS number: 93925-36-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- The in-vivo study is performed before in-vitro testing was preferably applied.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test is non-GLP but the parameters documented partially comply with a specific testing guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Propanoic acid, 2-hydroxy-, C12-15-alkyl esters
- EC Number:
- 300-338-1
- EC Name:
- Propanoic acid, 2-hydroxy-, C12-15-alkyl esters
- Cas Number:
- 93925-36-1
- Molecular formula:
- C3O2-C12/13/14/15
- IUPAC Name:
- Propanoic acid, 2-hydroxy-, C12-15-alkyl esters
- Reference substance name:
- Ceraphyl 41
- IUPAC Name:
- Ceraphyl 41
- Test material form:
- other: liquid
- Details on test material:
- Batch #5710
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- Every 24 hours for four days and on the seventh day.
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 16
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Highest score of 3 at 24 h, 2 at 48-72h.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 10
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Highest score for redness of 2 at 24 - 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: day 7
- Score:
- 12
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Highest score for redness of 3 at 24 h and of 2 at 48, 72 and 96 h.
- Other effects:
- Not recorded.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Installation of 0.1 ml of the test material into the right eye of three rabbits produced a moderate irritation involving only the conjunctivae. On the seventh day of observation these eyes were normal showing full reversibility.
- Executive summary:
CERAPHYL® 41 was mildly irritating to the eyes of rabbits. Three albino rabbits received a single application of CERAPHYL® 41 (0.1 ml) into the conjunctival sac of one eye. The contralateral eye, remaining untreated, served as a control. The eyes were examined and scored for effects on the cornea, iris and conjunctiva on Days 1, 2, 3, 4 and 7 after treatment. No corneal opacity or iritis was observed. Conjunctival irritation, noted in all the eyes, cleared by Day 7.
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