Butyl O-acetylricinoleate

Eye irritation

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

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

Test material information

Constituent 1

Reference substance name:

acetyltributyl citrate

Cas Number:

77-90-7

Molecular formula:

C20H34O8

IUPAC Name:

acetyltributyl citrate

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.