Jojoboa Oil

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: The EpiAirway™ Model provided by MatTek Corporation (Ashland, MA, USA)

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

Preliminary study:

The test articles: Jojoba Esters and, Isopropyl Jojobate and Jojoba Alcohol and Jojoba Esters, and Hydrolyzed Jojoba Esters, negative control (sterile deionized water) and positive control (14.7 mg/mL formaldehyde) were tested in the preliminary assay (16 May 2018).
At least 16 hours after initiating the tissues, the medium was removed from under the tissue and replaced with 1 mL of fresh pre-warmed AM. Immediately after refeeding, the tissues’ apical surface was rinsed twice with 0.4 mL of sterile Ca++Mg++Free-DPBS (CMF-DPBS) (warmed at 37°C) to remove a mucus layer that may be coating the apical surface of the tissues. The CMF-DPBS was added slowly to the apical side of the tissue (directed at the side of the cell culture insert, i.e. not directly onto the tissue surface) and then gently aspirated. The tissues were inverted and gently blotted on sterile absorbent to remove excess moisture.
Three concentrations (500, 250, and 50 mg/mL) were selected for each test article. One hundred μL of each test article were applied in a single EpiAirway™ tissue per concentration for 3 hours. A single tissue was treated with 100 μL of the negative and positive control for 3 hours. The tissues were incubated at standard culture conditions before being transferred to MTT.

Effect levels

Key result

Sex:

not specified

Dose descriptor:

other: EC75

Effect level:

>= 150 other: mg/mL

Based on:

not specified

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute inhalation toxicity potential of the test articles were evaluated in EpiAirway™ tissues using the methods and prediction model presented by MatTek.
All tested concentrations of the test articles: Jojoba Esters, Isopropyl Jojobate and Jojoba Alcohol and Jojoba Esters, and Hydrolyzed Jojoba Esters resulted in relative viabilities of ~100%, and therefore the EC75 was presented as greater than the highest tested dose.
According to the prediction models, an EC75 value greater than 150 mg/mL or 200 mg/mL would be consistent with an EPA Category IV or GHS Category 4-5, respectively. The test articles: Jojoba Esters, Isopropyl Jojobate and Jojoba Alcohol and Jojoba Esters, and Hydrolyzed Jojoba Esters would be predicted as EPA Category IV/GHS Category 4-5.