Rape oil, polymer with tung oil

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: ICCVAM - BALB/c 3T3 NRU Cytotoxicity Test Method

Deviations:

not applicable

GLP compliance:

yes

Test type:

other: ICCVAM-Recommended Test Method Protocol, BALB/c 3T3 NRU Cytotoxicity Test Method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Rape oil, polymer with tung oil

EC Number:

606-051-0

Cas Number:

185323-46-0

IUPAC Name:

Rape oil, polymer with tung oil

Test animals

Species:

other: H4IIE rat hepatoma cell line (ATCC)

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

H4IIE rat hepatoma cell line (ATCC)

Administration / exposure

Route of administration:

other: H4IIE rat hepatoma cell line (ATCC)

Vehicle:

other: Cremophor ELP (CAS# 61791-12-6)

Control animals:

not specified

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

approximate LD50

Effect level:

> 1 other: mg/ml

Based on:

test mat.

Any other information on results incl. tables

Summary of General Cytotoxicity

H4IIE cells were exposed to the vehicle/negative control (Cremophor ELP for Brassica Campestris/Aleurites Fordi Oil Copolymer, DMSO for Rotenone and Camptothecin), positive controls (Rotenone, Camptothecin), and the test article Brassica Campestris/Aleurites Fordi Oil Copolymer for 24 hr. After exposure, assays were performed according to the Materials and Methods. The predicted Ctox values were assessed using CeeTox proprietary algorithms. Data shown include general toxicity cell markers (TC50).

 

 

Ctox Ranking – Probability ofin vivoEffects
High	Moderate	Low

 

 

Test Article Name / Number	Cell NumberTC50(mg/ml)	MemToxTC50(mg/ml)	ATP TC50(mg/ml)	PredictedCtox(mg/ml)
Brassica Campestris/Aleurites Fordi Oil Copolymer H4IIE 24HR	>1	>1	>1	>0.03
	Cell NumberTC50(μM)	MemToxTC50(μM)	ATPTC50(μM)	PredictedCtox(μM)
ROTENONEH4IIE 24HR	0.09	0.5	0.1	0.05
CAMPTOTHECINH4IIE 24HR	3	>100	1	0.1

 

Cell Mass = Propidium Iodide.

MemTox = Membrane permeability: GST = α-glutathione S-transferase (membrane leakage). ATP = adenosine triphosphate.

ND = Not determined, NA = Not applicable, NC = No change.

TC50 = concentration that produced a half-maximal response. TC50 values estimated from graphs in figures 1-2. Ctox = Estimated sustained plasma concentration where toxicity would be expected to occur in vivo.

 

Note: Brassica Campestris/Aleurites Fordi Oil Copolymer was given a Ctox value of >0.03 and the ranking of low probability of in vivo effect.

Discussion

In this study, the H4IIE model was used to evaluate and characterize the test article, Brassica Campestris/Aleurites Fordi Oil Copolymer, in the In Vitro Toxicology Screen to provide an estimate of acute toxicity (Ctox value). The results of multiple biochemical assays in vitro are combined with a proprietary algorithm that identifies an estimated sustained blood concentration value (Ctox) where toxicity would occur in a 14-day repeat dose rat study in vivo.

The test article was tested at 0, 0.001, 0.003, 0.01, 0.03, 0.1, 0.3, and 1 mg/mL for a 24 hr exposure period. Test articles were soluble up to 0.03 mg/ml . Toxicity was not observed with the test article across the exposure range tested at 24 hr exposure. No apoptosis was observed via caspase 3 marker for either test article.

The predicted Ctox value was estimated to be >0.03 mg/ml for the test article Brassica Campestris/Aleurites Fordi Oil Copolymer . This places the test article in a category of low probability of in vivo effect.

Applicant's summary and conclusion

Conclusions:

In this study, the H4IIE model was used to evaluate and characterize the test article, Brassica Campestris/Aleurites Fordi Oil Copolymer, in the In Vitro Toxicology Screen to provide an estimate of acute toxicity (Ctox value). The results of multiple biochemical assays in vitro are combined with a proprietary algorithm that identifies an estimated sustained blood concentration value (Ctox) where toxicity would occur in a 14-day repeat dose rat study in vivo.
The test article was tested at 0, 0.001, 0.003, 0.01, 0.03, 0.1, 0.3, and 1 mg/mL for a 24 hr exposure period. Test articles were soluble up to 0.03 mg/ml. Toxicity was not observed with the test article across the exposure range tested at 24 hr exposure. No apoptosis was observed via caspase 3 marker for either test article.
The predicted Ctox value was estimated to be >0.03 mg/ml for the test article Brassica Campestris/Aleurites Fordi Oil Copolymer. This places the test article in a category of low probability of in vivo effect.