Plant Sterols

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:

other: The study was conducted accordign to a protocol comparable to current guideline and in compliance with GLP. However, a limitation of the study was that there was no information regarding the purity of the test substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

The back and flanks of 5 male and 5 female adult New Zealand White rabbits were clipped free of fur (ca 10% of total body surface), not more than 24 hours prior to study initiation. The skin was abraded (minor insicions through the stratum corneum) on 3 males and 2 females pror to dosing. 2g/kg (bw) of the test material was administered under an occlusive binding.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Not applicable-UVCB

EC Number:

619-079-3

Cas Number:

949109-75-5

Molecular formula:

UVCB- Mixture of many formulae.

IUPAC Name:

Not applicable-UVCB

Constituent 2

Reference substance name:

Plant sterol

IUPAC Name:

Plant sterol

Test material form:

other:

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

2 g/kg (bw) adminstered dermally.

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: One animal died during the study, but this was due to enteropathy, and was not substance related.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

In a well conducted acute dermal study in white New Zealand Albino Rabbits which were dosed 2g/kg (bw). No substance related effects were reported. The LD50 was taken to be greater than 2 g/kg (bw).