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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Evaluated as reliable by several authoritative bodies, such as CSTEE, U.S. Environmental Protection Agency, Cosmetic Ingredient Review Panel, etc.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Triethyl O-acetylcitrate
EC Number:
201-066-5
EC Name:
Triethyl O-acetylcitrate
Cas Number:
77-89-4
Molecular formula:
C14H22O8
IUPAC Name:
triethyl 2-acetoxypropane-1,2,3-tricarboxylate
Constituent 2
Reference substance name:
Acetyl triethyl citrate
IUPAC Name:
Acetyl triethyl citrate
Test material form:
other: liquid
Details on test material:
Acetyl triethyl Citrate, Citroflex A-2. no purity data.

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
72 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
O.1 ml was instilled into the left conjunctival sac. The right eye served as control. Observations were made at 20 minutes, 3, 5, 24, 48 and 72 h after a single application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: description
Basis:
animal #1
Time point:
other: 20 min
Reversibility:
fully reversible within: 3 h
Remarks on result:
other: Slight to moderate erythema of the conjunctiva was noted after 20 minutes; subsided by 3 h.
Irritation parameter:
other: description
Basis:
animal #2
Time point:
other: 3 h
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Another rabbit exhibited slight erythema after 3 h, resolved by 24 h.
Irritation parameter:
other: description
Basis:
animal #3
Time point:
other: 72
Remarks on result:
other: A third rabbit exhibited no irritation whatsoever
Irritant / corrosive response data:
Virtually non-irritating

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Eye irritation in three albino rabbits was investigated after conjunctival instillation of acetyl triethyl citrate, an analogue of triethyl citrate. The substance was evaluated as beining virtually non-irritating. Data can be read-across between the analogues (triethyl citrate, citric acid and acetyl triethyl citrate and acetyl tributyl citrate) based on common break-down products. This is adequate to fulfill the information requirements, to be the basis for classification and labelling decisions, and for risk assessment.