2-Octen-1-ylsuccinic anhydride, mixture of cis and trans

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Mar 2012 to May 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-(oct-2-en-1-yl)dihydrofuran-2,5-dione

EC Number:

629-679-7

Cas Number:

42482-06-4

Molecular formula:

C12H18O3

IUPAC Name:

3-(oct-2-en-1-yl)dihydrofuran-2,5-dione

Test material form:

other: Liquid

Details on test material:

Octenyl Succinic Anhydride
Lot#: 44514821
Gulf Bayport Chemicals

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Harlan Labs, Inc.
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 161 - 192 grams
- Fasting period before study: Overnight
- Housing:Single. In suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): ad libitum Harlan Teklad Global 16% protein Rodent diet #2016.
- Water (e.g. ad libitum): Filtered tap water ad libitum
- Acclimation period: 6-15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 degrees C
- Humidity (%): 26-69
- Air changes (per hr): 14-15 per hour
- Photoperiod (hrs dark / hrs light): 12/ 12

IN-LIFE DATES: From: To: Feb 20 - Mar 27, 2012

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Individual doses were calculated based on initial body weights, taking into account the density of the test substance as determined by PSL.

Doses:

Initially, a single animal received a limit dose of 2,000 mg/kg. Due to mortality of this animal, a main test was conducted. For the main test, the substance was administered in sequence to the animals, starting at 175 mg/Kg, progressing to 550 mg/Kg to a final dose of 2000 mg/Kg. The decision to proceed with the next animal was based on the survival of the previous animal following dosing.

No. of animals per sex per dose:

3 per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed once daily. Weighing on day 1, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights: Particular attention was paid to tremors, convulsions, salivation, diarrhea and coma.

Statistics:

The Acute Oral toxicity ( Guideline 425) statistical program (Westat, version 1.0, May 2001) was used for all data analysis including: dose progression selections, stopping criteria determinations and/ or LD 50 and confidence limit calculations.

Results and discussion

Preliminary study:

One animal given the limit dose of 2000 mg/ Kg did not survive.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

1 098 mg/kg bw

Based on:

test mat.

95% CL:

> 550 - < 2 000

Mortality:

Three animals died after receiving 2000 mg/kg. Three animals survived after receiving 550 mg/kg.

Clinical signs:

other: All animals given 2000 mg/kg died within one day of test substance administration.

Gross pathology:

Toxic signs included: irregular respiration, hyperactivity, abnormal posture, piloerection and/ or reduced fecal volume. Gross necropsy of the decedents revealed discoloration of the lungs and/or stomach and intestines, a mottled liver and/ or distention of the intestines and/or stomach.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Octenyl succinic anhydride (OSA) was tested in an up and down acute toxicity OECD 425 protocol in female rats. The LD50 was determined to be 1098 mg/kg bw. This is associated with CLP category IV for classification according to regulation EC No. 1272/ 2008.