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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin 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 dermal irritation potential of tributyl O-acetylcitrate in humans
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

Species:
other: humans
Strain:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
Sex: male and female
Age at study initiation: age from 21 to 60 years

Test system

Type of coverage:
other: patch test
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
no data available
Duration of treatment / exposure:
no data available
Observation period:
no data available
Number of animals:
59 human volunteers
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:
other: no data available
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
no irritation was observed

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Tributyl O-acetylcitrate was tested for dermal irritation and sensitization in human volunteers.
There was no evidence of irritation in the initial patch tests.
Hence, tributyl O-acetylcitrate can be considered as not irritating to human skin.
Executive summary:

Tributyl O-acetylcitrate was tested for dermal irritation and sensitization in human volunteers. 59 men and women volunteers ranging in age from 21 to 60 years were used for the study.Tributyl O-acetylcitrate was applied to the human skin and effects were observed.

There was no evidence of irritation in the initial patch tests.

Hence,tributyl O-acetylcitrate can be considered as not irritating to human skin.