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Administrative data

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
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-[(2E)-dodec-2-en-1-yl]oxolane-2,5-dione; 3-[(2Z)-dodec-2-en-1-yl]oxolane-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:
male/female
Details on test animals or test system and environmental conditions:
Five males and five nulliparous and non-pregnant females were used for testing. The rats were approximately 10 weeks of age, and weighed between 179 and 296 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: 19-22°C and 30-67%, respectively.
Animal Room Air Changes/Hour: 16. Airflow measurements are evaluated regularly.
Photoperiod: 12-hour light/dark cycle.
Acclimation Period: 14 days
Food: Harlan Teklad Global 16% Protein Rodent Die #2016. The diet was available ad libitum.
Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
On the day prior to application, a group of animals was prepared by clipping the dorsal area and the trunk. Two thousand milligrams of test substance per kilogram of body weight was applied evenly over a 2-inch x 3-inch, 4-ply gauze pad and placed on a dose area of approximately 2 inches x 3 inches (approximately 10% of the body surface). The gauze pad and entire trunk of each animal were then wrapped with 3-inch Durapore tape to avoid dislocation of the pad and to minimize loss of the test substance.
Duration of exposure:
24 hours
Doses:
2000 mg/kb bw
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
0
Clinical signs:
other: There were no other adverse clinical findings recorded for any of the animals over the course of the study.
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the single dose acute dermal LD50 of 2-dodecenyl succinic anhydride is greater than 2,000 mg/kg of body weight in male and female rats.