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Eye irritation

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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:
1978
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

Constituent 1
Chemical structure
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
Constituent 2
Chemical structure
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
Constituent 3
Chemical structure
Reference substance name:
Propanoic acid, 2-hydroxy-, tetradecyl ester with dimers
Molecular formula:
C20H38O5
IUPAC Name:
Propanoic acid, 2-hydroxy-, tetradecyl ester with dimers
Constituent 4
Chemical structure
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

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.