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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP.

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:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(2-dodecenyl)succinic anhydride
EC Number:
243-296-9
EC Name:
3-(2-dodecenyl)succinic anhydride
Cas Number:
19780-11-1
Molecular formula:
C16H26O3
IUPAC Name:
3-dodec-2-en-1-yldihydrofuran-2,5-dione
Test material form:
other: Waxy solid
Details on test material:
Lot #: 210111899. The test substance was stored at room temperature. Expiration Date: Not applicable.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
Five female, nulliparous, non-pregnant rats. 9-10 weeks of age. 178-229 grams at experimental start.
Housing: The animals were singly housed in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cage and was changed at least three times per week.
Animal Room Temperature and Relative Humidity Ranges: 19-21°C and 30-69%, respectively.
Animal Room Air Changes/Hour: 13. Airflow measurements are evaluated regularly.
Photoperiod: 12-hour light/dark cycle.
Acclimation Period: 9-20 days.
Food: Harlan Teklad Global 16% Protein Rodent Diet® #2016. The diet was available ad libitum, except during fasting.
Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.
Contaminants: There were no known contaminants reasonably expected to be found in the food or water at levels which would have interfered with the results of this study. Analyses of the food and water are conducted regularly.



Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
The test substance was administered as a 40% w/w mixture in 0.5% w/v solution of CMC in distilled water to the stomach using a stainless steel ball-tipped gavage needle attached to an appropriate syringe. Following administration, each animal was returned to its designated cage. Feed was replaced approximately 3-4 hours after dosing.
Doses:
The rats were each dosed at 2,000 mg/kg of body weight.
No. of animals per sex per dose:
1
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
0
Clinical signs:
All animals survived test substance administration and gained body weight during the study. Clinical signs noted for these animals following administration included reduced fecal volume, ano-genital staining, diarrhea and/or soft feces, but the animals recovered from these symptoms by Day 4 and appeared active and healthy for the remainder of the observation period.
Body weight:
Between 178 and 229 grams at experimental start.
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU