Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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.