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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Justification for type of information:
Both the source and target substances in this read across are mono-constituent substances composed of the
same chemical groups and linked together in functionally the same way. The impurities present in both
substances are structurally similar to the source and target substances and are not expected to impact on the
predicted result, or reliability of the predicted result.
The source substance was determined not to be either a skin or eye irritant. The irritation potential of the target
substance is expected to be the same as the source substance. The predicted result is therefore considered
by the registrant to be acceptable for registration, classification and labelling, and PBT/vPvB purposes.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The registered substance is not considered an eye irritant based upon the read across approach to an analogous substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
not specified
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Trihexadecyl citrate
EC Number:
224-931-9
EC Name:
Trihexadecyl citrate
Cas Number:
4560-68-3
Molecular formula:
C55H106O6
IUPAC Name:
trihexadecyl citrate
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
All animals were free from visible ocular defects at the start of the test.

Test system

Vehicle:
other: Corn oil
Controls:
not required
Amount / concentration applied:
0.1 ml 25%
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
Six New Zealand white rabbits, free from visible ocular defects, each received a single intraocular application of 0.1 ml of the test article in one eye. the contralateral eye, remaining untreated, served as a control. The eyes of all animals remained unwashed for 24 hours. Observations of corneal opacity, iritis, and conjunctivitis were recorded 24, 48, 72 hours after treatment, and at 4 and 7 days if irritation persisted. The test article was used as a 25% gravimetric corn oil suspension.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
The test article is not an ocular irritant to rabbits under the conditions of this test.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test article was determined not to be an eye irritant to rabbits.
Executive summary:

In this guideline (EPA OPP 81-4) study the test article was determined not to be an eye irritant to rabbits. Six New Zealand white rabbits were tested with a single 25% suspension in cornoil dose (0.1 ml) in a single eye. The rabbits were observed daily for 72 hours and for up to 7 days for signs of irritation. No corneal opacity, iritis, or conjunctivitis were observed at any observation period.