3-(2-dodecenyl)succinic anhydride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

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.

Test animals

Species:

rabbit

Strain:

other: New Zealand albino

Details on test animals or test system and environmental conditions:

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: 19-23°C and 33-66%, respectively.
Animal Room Air Changes/Hour: 12. Airflow measurements are evaluated regularly.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 9 days
Food: Harlan Teklad Global High Fiber Rabbit Diet® #2031. A designated amount of the diet was available to each rabbit (approximately 150 grams/day).
Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours.

Observation period:

30-60 minutes, 24, 48, and 72 hours, and 7, 10 and 14 days.

Number of animals:

3

Details on study design:

Five-tenths of a gram of the test substance was applied to a 1-inch x 1-inch, 4-ply gauze pad and placed on one 6-cm2 intact dose site on each animal. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit and they were returned to their designated cages.
After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites were gently cleansed of any residual test substance.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 hours

Score:

6.4

Max. score:

8

Reversibility:

fully reversible

Remarks on result:

other: Values over 5 are considered "severely irritating".

Irritant / corrosive response data:

Within 24 hours after patch removal, well-defined to moderate/severe erythema and moderate to severe edema were noted for all three treated dose sites. The overall severity of irritation decreased gradually with time. Hyperkeratosis was evident at all dose sites at 48 and/or 72 hours. Desquamation and shiny skin were present at all three dose sites from Day 7 through 14. Although edema cleared from all three treated dose sites by Day 14, very slight erythema persisted at one dose site with desquamation and shiny skin at all sites through study termination (Day 14).
The Primary Dermal Irritation Index was 6.4

Other effects:

All animals appeared active and healthy during the study. Apart from the dermal irritation noted below, there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior.

Any other information on results incl. tables

Table 2: Summary of Primary Skin Irritation Scores

	Time after patch removal
	30-60 min	24 hrs	48 hrs	72 hrs	Day 7	Day .10	Day 14
Erythema	2.0	3.3	3.3	3.3	2.0	1.0	0.3
Edema	3.0	4.0	3.3	3.3	1.7	0.7	0
TOTAL (PDI)^2	5.0	7.3	6.6	6.6	3.7	1.7	0.3

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this OECD 404 study, 2-dodecenyl succinic anhydride is classified as severely irritating to the skin.