2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.

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:

other: GLP- and guideline compliant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.

EC Number:

272-221-2

EC Name:

2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.

Cas Number:

68784-12-3

Molecular formula:

Due to a mixture of numerous isomers a specific molecular formular cannot be provided ( UVCB-substance) .

IUPAC Name:

2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.

Details on test material:

- Name of test material (as cited in study report): ASA
- Substance type: organic
- Physical state: Liquid/ yellowish, clear
- Analytical purity: ASA content: 97.1%
- Purity test date: no data
- Lot/batch No.: 5500001727
- Expiration date of the lot/batch: 31.10.2013
- Stability under test conditions: stable
- Storage condition of test material: Room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: 10 weeks
- Weight at study initiation: 176.7-179.3 g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum
- Housing:Makrolon cage, type III; Single housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24°C
- Humidity (%): 20 – 80%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.08 mL

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of
observation.Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. A check for any dead or moribund animal was made at least once each workday.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Calculations were performed using Microsoft Excel 2003 and checked with a calculator.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were observed during clinical examination.

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of
the observation period.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the median lethal dose of ASA after oral administration was found to be greater than 2000 mg/kg bw in rats.

Executive summary:

In an acute oral toxicity study performed according to the OECD 423 under GLP, 2000 mg/kg bw of the undiluted test-item was administered to two test groups of three fasted Wistar rats each by gavage. Because no mortality occurred in the six females administered 2000 mg/kg bw within the 14 day observation perid, the LD50 was estimated to be >2000 mg/kg bw.