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EC number: 947-847-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- 1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
See attachment
2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
See attachment
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- REPORTING FORMAT FOR THE CATEGORY APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The category of alkyl lactates mainly contain data on propanoic acid, 2-hydroxy, C12-C16 (even and odd numbered) alkyl esters.
2. SOURCE AND TARGET CHEMICALS
Both the target and the analogues are produced by esterification of alcohols and lactate.
3. ANALOGUE APPROACH JUSTIFICATION
Since there is a significant relation between the analogues measured and the target substance, which only differs in chain length of the alcohol, read-across is here justified.
See section 13 for RA-Justification_Assessment report - Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- 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
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: day 7
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: Score of 3 at 24 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #3
- Time point:
- other: 72h, 96h and day 7
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Score of 2 at 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 96 and day 7
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: Score of 3 at 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: day 7
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Score of 2 at 24 - 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #2
- Time point:
- other: 48-day 7
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Score of 1 at 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 96 h - day 7
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Score of 2 at 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: day 7
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: Score of 3 at 24 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #1
- Time point:
- other: 48h - day 7
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Score of 1 at 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 72h - day 7
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Score of 2 at 24 h
- Other effects:
- Not recorded.
- Interpretation of results:
- moderately irritating
- 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. The observed irritation may well have been due to the presence of the C12-15 alcohols.
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- method used was a modified Draize method.
- GLP compliance:
- no
Test material
- Reference substance name:
- Tetradecyl lactate
- EC Number:
- 215-350-1
- EC Name:
- Tetradecyl lactate
- Cas Number:
- 1323-03-1
- Molecular formula:
- C17H34O3
- IUPAC Name:
- tetradecyl 2-hydroxypropanoate
- Reference substance name:
- Tetradecanol
- EC Number:
- 204-000-3
- EC Name:
- Tetradecanol
- Cas Number:
- 112-72-1
- Molecular formula:
- C14H30O
- IUPAC Name:
- tetradecan-1-ol
- Reference substance name:
- Propanoic acid, 2-hydroxy-, tetradecyl ester with dimers
- Molecular formula:
- C20H38O5
- IUPAC Name:
- Propanoic acid, 2-hydroxy-, tetradecyl ester with dimers
- Reference substance name:
- Propanoic acid, 2-hydroxy-, tetradecyl ester with trimers
- Molecular formula:
- C23H42O7
- IUPAC Name:
- Propanoic acid, 2-hydroxy-, tetradecyl ester with trimers
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zeland
- Details on test animals or tissues and environmental conditions:
- Animals were received from Summit view farm, Belvidere, New Jersey. The animals are fed and watered ad libitum; with wayne animal feeds used exclusively. Text material were applied on intact and abraded skin and was covered with an impermeable occlussive wrapping. The wrapping were removed 24h following application.
Test system
- Vehicle:
- not specified
- Controls:
- other: the left eye that was untreated served as a control
- Amount / concentration applied:
- 0.1ml per eye
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- other: Total score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- other: Total score
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- no indication of irritation
- Other effects:
- no other effect
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test compound is not an ocular irritant.
- Executive summary:
The numerical scoring point according to Draize standard scoring was 0. Thus, the test compound is not an ocular irritant.
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