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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

Constituent 1
Chemical structure
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.