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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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
Citric acid and its inorganic salts and alkyl and glycol esters as used in cosmetics - draft safety assessment
Author:
Anon.
Year:
2011
Bibliographic source:
Cosmetic ingredient review

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Remarks:
Study conducted in 1977, prior to or at the time of the introduction of GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Triethyl citrate
EC Number:
201-070-7
EC Name:
Triethyl citrate
Cas Number:
77-93-0
Molecular formula:
C12H20O7
IUPAC Name:
triethyl 2-hydroxypropane-1,2,3-tricarboxylate
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
other: alcohol SDA 39C
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 15%
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Reversibility:
not specified
Irritant / corrosive response data:
Triethyl citrate at a concentration of 15% in alcohol SDA 39C resulted in conjunctival irritation and corneal opacity which had not resolved within 7 days.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Executive summary:

Ocular irritation has been investigated in the rabbit. Triethyl citrate at a concentration of 15% in alcohol SDA 39C resulted in conjunctival irritation and corneal opacity which had not resolved within 7 days. From the available information it is not known if the response is the result of the intrinsic properties of triethyl citrate or has been influenced by the vehcile used, an alcohol.