Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from safety assessment reports

Data source

Reference
Reference Type:
secondary source
Title:
Review of Exposure and Toxicity Data for Phthalate Substitutes
Author:
Versar, Inc, Exposure and Risk Assessment Division and Syracuse Research Corporation (SRC)
Year:
2010
Bibliographic source:
Review of Exposure and Toxicity Data for Phthalate Substitutes; Versar, Inc, Exposure and Risk Assessment Division and Syracuse Research Corporation (SRC); 2010

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the ocular irritation potential of Acetyl tri-n-butyl citrate (ATBC) in rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Name of the test chemical:Acetyl tri-n-butyl citrate (ATBC)
Molecular Formula:C20H34O8
Molecular Weight:402.4806 g/mol
Substance Type:Organic
Physical State: liquid
Specific details on test material used for the study:
Name of the test chemical:Acetyl tri-n-butyl citrate (ATBC)
Molecular Formula:C20H34O8
Molecular Weight:402.4806 g/mol
Substance Type:Organic
Physical State: liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
Sex: male

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
no data available
Observation period (in vivo):
5, 24,48 and 72 hours
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
3
Details on study design:
no data available

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Moderate erythema was observed in two of the three test rabbits within 20 minutes. The erythema subsided in one of the rabbits after 5 hours, but persisted beyond 24 hours in the other. No irritation was observed in any rabbit at 48 or 72 hours post instillation.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Moderate erythema was observed in two of the three test rabbits within 20 minutes. The erythema subsided in one of the rabbits after 5 hours, but persisted beyond 24 hours in the other. No irritation was observed in any rabbit at 48 or 72 hours post instillation.Hence, Tributyl O-acetylcitrate can be considered as not irritating to rabbit eyes.
Executive summary:

Tributyl O-acetylcitrate was tested for ocular irritation in 3 male albino rabbits. 0.1 ml Tributyl O-acetylcitrate was instilled into the left conjunctival sac of three male albino rabbits, with the contra-lateral eyes serving as controls.Moderate erythema was observed in two of the three test rabbits within 20 minutes. The erythema subsided in one of the rabbits after 5 hours, but persisted beyond 24 hours in the other. No irritation was observed in any rabbit at 48 or 72 hours post instillation. Hence, Tributyl O-acetylcitrate can be considered as not irritating to rabbit eyes.