Jojoboa Oil

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Epiderm Skin Model, cytotoxicity, MTT method

Version / remarks:

The experimental design is based on the original validation study performed by ZEBET (2000).

Principles of method if other than guideline:

Alternative testing to avoid the use of animals.
The experimental design is based on the original validation study performed by ZEBET (2000). A number of doses of the test article will be determined and idluted in the appropriate vehicle. The appropriate number of EpiDerm tissues will be treated with the test article or control dilutions for approximately 24 hours to allow penetration into the living tissue. Then, half of the cultures in each tratment group will ne subjected to 6 J/cm² of UVA light. The remaining half of each treatment group will be held at roon temperature in the dark. All the tissues will be returned to the incubator for a post exposure period of 21 +/- hours. The phototoxicity and toxicity of each test article are evaluated on the basis of cytotoxicity (i.e., the relative conversion of MTT by the EpiDerm tissues). Cytotoxicity data are presented in the form of relative survival (relative MTT conversion).

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

no defined IUPAC name

EC Number:

612-381-6

Cas Number:

61789-91-1

Molecular formula:

no molecular structure defined

IUPAC Name:

no defined IUPAC name

Test material form:

semi-solid (amorphous): gel

Details on test material:

Components Floraesters 30
Wax Ester ---
36:2 <2
38:0 <1
38:1 2 - 4
38:2 2 - 4
40:0 2 - 4
40:1 14 - 18
40:2 17 - 21
42:0 2 - 4
42:1 14 - 18
42:2 17 - 21
44:0 <2
44:1 4 - 7
44:2 4 - 7
46:2 <3
Iodine Value** 57 - 61
Mono-ester content*** 40 - 47

Results and discussion

Effect levels

Key result

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Remarks:

did not show phototoxic effects at any of the tested concentrations.

Applicant's summary and conclusion

Conclusions:

The test article, Jojoba Esters, did not show phototoxic effects at any of the tested concentrations. Since the positive control, 0.02% chlorpromazine in HBSS, induced at least a 30% decrease in tissue viability in the presence of UVA exposure, compared to the viability in the absence of UVA exposure, the assay was considered valid.