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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Judged to be scientifically reliable and appropriate for risk assessment by the Expert Panel of dermatologists and scientists at the Cosmetics Ingredient Review, Washington, DC., USA.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: 16 CFR 1500.41
Version / remarks:
U.S. Federal Hazardous Substances Act
Principles of method if other than guideline:
Similar to OECD 404 but occlusive exposure to the test material for 24 h. Observation period is 14 days.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Trihexyl O-acetylcitrate
Cas Number:
24817-92-3
Molecular formula:
C26 H46 O8
IUPAC Name:
Trihexyl O-acetylcitrate
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
other: albino, likely New Zealand white
Details on test animals or test system and environmental conditions:
Mean body weight for one group was 2.29 kg (intact) and the other was 2.81 kg (abraded group)

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact skin and abraded in separate groups
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
2000 mg/kg bw
Duration of treatment / exposure:
24 h
Observation period:
14 d
Number of animals:
10 total, 5 for intact skin exposure, 5 for abraded skin exposure.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 2/5
Remarks:
at abraded site
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 1/2 with erythema persisted to day10; erythema was not related to test material application
Irritation parameter:
other: Desquamation
Basis:
other: 3/5
Time point:
other: day 5-6
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
other: very slight to slight desquamation
Irritation parameter:
other: desquamation
Remarks:
in Intact skin group
Basis:
other: 2/5
Time point:
7 d
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: very slight to slight desquamation
Irritant / corrosive response data:
No erythema or edema effects were seen at intact skin sites. No edema was observed in any animal during the study.
Of the animals with abraded skin which displayed erythema, the extent was judged to be very mild (score 1 of 4). This resolved in one animal by day 3, but persisted to day 10 in the second. This was judeged by the study director to be unrelated to ATHC administration.

Desquamation, very slight to slight, was observed in five rabbits (three abraded skin, and two intact skin). The onset was day 5 or 6, and was cleared by day 10. At intact sites, desquamation was observed on day 6 or 7 only.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was applied to the skin of rabbits in a very aggressive skin irritation protocol (US FHSA, 16 CFR 1500.41). The findings of no effects in intact skin does not meet the criteria for classification under the CLP regulation. The substance is not classified.