Jojoboa Oil

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EPA: Endocrine Disruptor Screening Program Test Guidelines: OPPTS 890.1550 Steroidogenesis (Human Cell Line-H295R)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD Guidelines for Testing of Chemicals, No. 456 “H295R Steroidogenesis Assay“, adopted July 28, 2011

Principles of method if other than guideline:

This in vitro method analyses the endocrine potential of the test item. The test is carried out using the human adrenocortical carcinoma cell line H295R cultured with different concentrations of the test item. The viability of the cells is tested via the MTT staining to exclude cytotoxic impacts of the test chemical. The endocrine effect is registered via the testosterone and estradiol content of the cell culture supernatants as compared to the solvent control.
The goal of the assay is to provide a YES/NO answer with regard to the potential of a chemical to induce or inhibit the production of testosterone and estradiol. The results of the assay are expressed as relative changes in hormone production compared with the solvent control.

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

Results: P0 (first parental generation)

Effect levels (P0)

Remarks on result:

not measured/tested

Target system / organ toxicity (P0)

Critical effects observed:

not specified

Results: P1 (second parental generation)

Effect levels (P1)

Remarks on result:

not measured/tested

Target system / organ toxicity (P1)

Critical effects observed:

not specified

Results: F1 generation

Effect levels (F1)

Remarks on result:

not measured/tested

Target system / organ toxicity (F1)

Critical effects observed:

not specified

Results: F2 generation

Effect levels (F2)

Remarks on result:

not measured/tested

Target system / organ toxicity (F2)

Critical effects observed:

not specified

Overall reproductive toxicity

Reproductive effects observed:

no

Applicant's summary and conclusion

Conclusions:

In this study under the given conditions, the test item of Floraesters 30 (INCI: Jojoba Esters) did not induce or inhibit the production of testosterone significantly. Therefore, the test item can be judged negative for testosterone induction or inhibition.

In this study under the given conditions, the test item of Floraesters 30 (INCI: Jojoba Esters) did not induce or inhibit the production of 17β-estradiol significantly. Therefore, the test item can be judged negative for estradiol induction or inhibition.