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Toxicological information

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:
21/03/2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium undec-10-enoate
EC Number:
222-264-8
EC Name:
Sodium undec-10-enoate
Cas Number:
3398-33-2
Molecular formula:
C11H20O2.Na
IUPAC Name:
sodium undec-10-enoate
Specific details on test material used for the study:
sodium undec-10-enoate in a 33.2% aqueous solution

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A single dose of 0.1ml of the test substance was instilled into the conjunctival sac of the left eye of one male New Zealand White rabbit.
Observation period (in vivo):
the ocular reactions
Number of animals or in vitro replicates:
3
Due to the ocular reactions recorded in the first animal, the study was not undertaken in the 2 other animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
ca. 2
Max. score:
3
Reversibility:
fully reversible within:
Remarks:
eleven days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
ca. 2
Max. score:
3
Reversibility:
fully reversible within:
Remarks:
eleven days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
ca. 3
Max. score:
3
Reversibility:
fully reversible within:
Remarks:
eleven days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
eleven days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
eleven days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
eleven days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within:
Remarks:
eleven days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within:
Remarks:
eleven days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within:
Remarks:
eleven days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The substance sodium undec-10-enoate ( in a 33.2% aqueous solution) is considered as irritant in the rabbit. the ocular lesions were more marked after 72 jours and were totally reversible on the eleventh day of observation.
Executive summary:

The eye irritation study was performed according to the OECD 405 guideline. -

A single dose of 0.1ml of the substance sodium undec-10-enoate (in a 33.2% aqueous solution) was instilled into the conjunctival sac of one rabbit.

The substance is considered as eye irritant in the rabbit.