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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4/10/1978 to 4/13/ 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-like (QA signature), guideline study with 24 hour exposure and termination at 72 hours without evidence of reversibility

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: US 16 CFR 1500.41
Deviations:
no
Principles of method if other than guideline:
The skin of six rabbits was clipped over a wide area. One side was abraded; the other side remained intact. A 0.5 ml portion of the test material was administered to the abraded and intact skin of each animal. The treated sites were covered with a gauze patch and then covered by an impervious material wrapped snuggly around the trunks. After 24 hours the wrapping were removed. Each site was evaluated at 24 and 72 hours according to method of Draize.
GLP compliance:
yes
Remarks:
Study predates GLP regulations, but QA signature is available.

Test material

Constituent 1
Chemical structure
Reference substance name:
Dihydro-3-(tetrapropenyl)furan-2,5-dione
EC Number:
247-781-6
EC Name:
Dihydro-3-(tetrapropenyl)furan-2,5-dione
Cas Number:
26544-38-7
Molecular formula:
C16H26O3
IUPAC Name:
3-dodecenyl dihydrofuran-2,5-dione

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
6 rabbits
Details on study design:
The skin of six rabbits was clipped over a wide area. One side was abraded; the other side remained intact. A 0.5 ml portion of the test material was administered to the abraded and intact skin of each animal. The treated sites were covered with a gauze patch and then covered by an impervious material wrapped snuggly around the trunks. After 24 hours the wrapping were removed. Each site was evaluated at 24 and 72 hours according to method of Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Intact
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
Abraded
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
Intact
Basis:
mean
Time point:
other: 24and 72 hours
Score:
1.5
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
Abraded
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.58
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
The Primary Irritation Score was 3.29. This is below the value of 5 required for classification as a skin irritant.

Any other information on results incl. tables

Erythema Scores

 

 

Rabbit Number

 

1

2

3

4

5

6

Intact skin

24

2

2

2

2

2

2

Intact skin

72

2

1

1

2

1

2

Abraded skin

24

2

2

2

2

2

2

Abraded skin

72

2

1

1

2

1

2

Subtotal: 7.0 

Edema Scores

 

 

Rabbit Number

 

 

1

2

3

4

5

6

Intact skin

24

1

2

2

2

1

2

Intact skin

72

2

1

1

2

1

1

Abraded skin

24

1

2

2

2

1

2

Abraded skin

72

2

1

1

2

1

2

Subtotal: 6.15

Total: 13.15

Primary Irritation Score: 13.15 ÷ 4 = 3.29

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Tetrapropenyl succinic anhydride (TPSA) was tested for skin irritation in rabbits in a guideline protocol (US 16 CFR 1500.41). When applied to the clipped intact and abraded skin under occlusive wrappings for 24 hours, the substance was not irritating. The substance is not classified as an irritant according to Regulation EC No. 1272/2008.
Executive summary:

The skin irritation potential of this substance was evaluated in rabbits. The skin of six rabbits was clipped over a wide area. One side was abraded; the other side remained intact. A 0.5 ml portion of the test material was administered to the abraded and intact skin of each animal. The treated sites were covered with a gauze patch and then covered by an impervious material wrapped snuggly around the trunks. After 24 hours the wrapping were removed. Each site was evaluated at 24 and 72 hours according to method of Draize. The calculated mean 24 -72 hour scores for erythema and edema for intact skin was 1.75 and 1.5, respectively; and the calculated mean 24 -72 hour scores for erythema and edema for abraded skin was 1.75 and 1.58, respectively. The irritation effects were not reversible by the final observation at 72 hours.