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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation / corrosion

Currently viewing:

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
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

Constituent 1
Chemical structure
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

Species:
other: humans
Strain:
not specified
Details on test animals or test system 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.