Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
presumably 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only results given. Publication has lack of methodical details

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Acetyl Triethyl Citrate, Acetyl Tributyl Citrate, Acetyl Trihexyl Citrate, and Acetyl Trioctyl Citrate
Author:
Cosmetic Ingredient Review
Year:
2002
Bibliographic source:
International Journal of Toxicology, 21(Suppl. 2):1–17

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
1.) 3 male albino rabbits were used. The abdomen were closely clipped and 1 mL/kg bw was placed on the intact skin daily for 4 days. The animals were observed daily and for a period of 36 h after the last application.

2.) 3 male albino rabbits were used. 1 mL/kg was placed on the closely clipped abdomen for a total of 18 applications (6 d per week). Animals were observed daily and for a period of two weeks following the last application.

GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Triethyl O-acetylcitrate
EC Number:
201-066-5
EC Name:
Triethyl O-acetylcitrate
Cas Number:
77-89-4
Molecular formula:
C14H22O8
IUPAC Name:
triethyl 2-acetoxypropane-1,2,3-tricarboxylate

Test animals

Species:
rabbit
Strain:
other: Albino
Details on test animals or test system and environmental conditions:
no further data

Test system

Type of coverage:
not specified
Preparation of test site:
other: intact / abraded
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
1 mL/kg bw (ca. 1000 mg/kg)
Duration of treatment / exposure:
4 - 18 applications
Observation period:
36 h to 2 weeks after last application
Number of animals:
2-3
Details on study design:
see above

Results and discussion

In vivo

Results
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritant effects noted

Any other information on results incl. tables

Individual scores were not given. Examination time points: 36 h to 2 weeks after last application.

The skin irritation potential of Acetyl Triethyl Citrate was evaluated using three male albino rabbits. The test substance (1 cc/kg body weight) was inuncted onto intact abdominal skin that had been clipped free of hair. This procedure was repeated daily for 4 days. The animals were observed daily for up to 36 hours after the last application. Acetyl Triethyl Citrate did not induce skin irritation in any of the three rabbits tested .

In another study, Acetyl Triethyl Citrate (1 cc/kg body weight) was inuncted onto intact abdominal skin of each of three male albino rabbits for a total of 18 applications (6 days/week). The animals were then observed over a period of 2 weeks. Body weights were normal throughout the study. Skin irritation was not observed in any of the animals .

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
ATEC was not skin irritating. Classification criteria are not meet.
Executive summary:

In all of the 2 trials there was no indication for skin irritation.