Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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
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:
3
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:
4
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:
80
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: all
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
3
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:
7 d
Score:
0
Max. score:
3
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:
4
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:
80
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: all
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
7 d
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:
3
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:
4
Reversibility:
fully reversible
Remarks on result:
other: Score of 2 at 24 h
Other effects:
Not recorded.

Applicant's summary and conclusion

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.
Executive summary:

C12 -15 alkyl lactates were 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.