Reaction products of furan-2,5-dione and octadec-1-ene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

guideline study under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-[(2E)-octadec-2-en-1-yl]dihydrofuran-2,5-dione

Cas Number:

1628163-42-7

Molecular formula:

C22H38O3

IUPAC Name:

3-[(2E)-octadec-2-en-1-yl]dihydrofuran-2,5-dione

Constituent 2

Reference substance name:

3-[(2Z)-octadec-2-en-1-yl]dihydrofuran-2,5-dione

Molecular formula:

C22H38O3

IUPAC Name:

3-[(2Z)-octadec-2-en-1-yl]dihydrofuran-2,5-dione

Constituent 3

Reference substance name:

3-(octadecenyl)dihydrofuran-2,5-dione excluding 3-(2-octadecen-1-yl)dihydrofuran-2,5-dione

Molecular formula:

C22H38O3

IUPAC Name:

3-(octadecenyl)dihydrofuran-2,5-dione excluding 3-(2-octadecen-1-yl)dihydrofuran-2,5-dione

Constituent 4

Reference substance name:

Hexadecenylsuccinic anhydride

EC Number:

250-911-4

EC Name:

Hexadecenylsuccinic anhydride

Molecular formula:

C20H34O3

IUPAC Name:

3-(hexadecenyl)dihydrofuran-2,5-dione

Constituent 5

Reference substance name:

3-icosenylsuccinic anhydride

EC Number:

258-603-1

EC Name:

3-icosenylsuccinic anhydride

Molecular formula:

C24H42O3

IUPAC Name:

3-icosenyldihydrofuran-2,5-dione

Constituent 6

Reference substance name:

Side products from the reaction of octadec-1-ene and maleic anhydride

Molecular formula:

Not applicable - UVCB component

IUPAC Name:

Side products from the reaction of octadec-1-ene and maleic anhydride

Constituent 7

Reference substance name:

C16-20 (even numbered) alkenes (branched and linear)

Molecular formula:

C16H32, C18H36, C20H40

IUPAC Name:

C16-20 (even numbered) alkenes (branched and linear)

Constituent 8

Reference substance name:

Maleic anhydride

EC Number:

203-571-6

EC Name:

Maleic anhydride

Cas Number:

108-31-6

Molecular formula:

C4H2O3

IUPAC Name:

furan-2,5-dione

Test material form:

solid

Details on test material:

off-white solid, amber liquid at 80 °C. Expected to be stable for duration of testing; Expiration date: not applicable.

Specific details on test material used for the study:

As a result of increasingly rigorous criteria being applied to the analysis of commercial material used in physical property/toxicity testing, the identity of the material has been modified to reveal a more accurate and precise depiction of the commercial substance. This enhancement is reflected in changes in chemical identifiers such as EC and/or CAS numbers from those noted in earlier versions of data records or in study reports.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories, Inc.
- Age at study initiation: 8-12 weeks
- Weight at study initiation:
- Fasting period before study: no
- Housing: nimals will be housed singly in suspended stainless steel perforated bottom cages or plastic solid bottom cages. Litter paper placed beneath the cage will be changed at least three times/week or Corncob bedding (1/4 inch bed-o'-cobs®, or equivalent) will be changed at least once per week.
- Diet (e.g. ad libitum): Harlan Teklad Global 16% Protein Rodent Diet® #2016, ad libitum.
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 3C
- Humidity (%): 30-70%,
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Several trials were undertaken to solubilize this waxy solid test material in a suitable vehicle for oral gavage administration to rats. Care needed to be taken to avoid aqueous solvents, as the material hydrolyses in water. The substance was gently warmed to 80 degrees C and solubilized in corn oil, which, when cool, was administered to the animals.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Limit Test at 2000 mg/kg: If the initial animal survives following dosing, the test substance will be administered sequentially to four additional females so that a total of five animals are dosed; however, if at any time three animals die, the limit test will be terminated and the main test will be conducted. If an animal dies late in the observation period, all dosing should be stopped and the animals already on test should be observed for a similar period prior to proceeding. The LD50 of the test substance will be considered greater than the limit dose if three or more animals out of five survive.

Statistics:

Dose progression and stopping criteria will be calculated using a dedicated software program (Acute Oral Toxicity (Guideline 425) Statistical Program) provided by the U.S. Environmental Protection Agency (EPA).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths; LD0 > 2000 mg/kg bw.

Mortality:

No deaths occurred at 2000 mg/kg bw. The LD50 is greater than 2000 mg/kg bw.

Clinical signs:

other: No signs of toxicity

Gross pathology:

No findings on gross pathology

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information: The LD50 is greater than 2000 mg/kg bw, and so is not classified according to Regulation EC No. 1272/2008.

Conclusions:

n-ODSA was tested in an OECD 425 Up-and-down protocol according to GLP, and the LD50 was found to be greater than 2000 mg/kg bw.