[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

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., U.S.A.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.3

Version / remarks:

compliant with U.S. CPSC

Principles of method if other than guideline:

This summary data provided in a peer-reviewed publication reflects the opinion of the CIR Expert Panel that the test data are valid and informative. The study was commissioned by the Cosmetics, Toiletries and Fragrance Association (CTFA), now the Personal Care Products Council (PCPC), which generally selects OECD-compliant protocols (or FDA protocols which are aligned with OECD guidelines) and requires execution of the study under GLP.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

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

Specific details on test material used for the study:

Purity > 99% ATHC, Volatiles 1.4%.

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Female albino rabbits were divided equally into two groups (intact and abraded test sites, respectively). The mean body weight was 2.29 for one group (intact) and 2.81 kg (abraded sites) for the other group.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Skin in one group of animals is abraded, skin of the other group is intact. The test material is applied on gauze and covered with an occlusive dressing for 24 h.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw (2 g/kg).

No. of animals per sex per dose:

5 per sex per dose

Control animals:

not required

Details on study design:

The animals are observed after the application and at least once daily. The obsrvation period is 14 days. Animals are euthanised at 14 days, and necropsied are undertaken.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No dealths occurred.

Clinical signs:

other: No clinical signs of systemic toxiicty.

Gross pathology:

No changes were observed in any of the animals tested.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was tested in an acute dermal toxicity study in 10 male/female rabbits at doses of 2000 mg/kg bw. Within the 14-day observation period, there were no deaths or clinical effects among the animals. The LD50 is > 2000 mg/kg bw. The substance does not meet the criteria for classification for acute oral toxicity according to Regulation EC No. 1272/2008.