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Toxicological information

Eye irritation

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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:
1970
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

Constituent 1
Chemical structure
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
Constituent 2
Reference substance name:
Ceraphyl 41
IUPAC Name:
Ceraphyl 41
Test material form:
other: liquid
Details on test material:
Batch #5710

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.