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Diss Factsheets

Administrative data

Description of key information

Tetrapropenyl succinic anhydride was tested in guideline protocols for skin and eye irritation.  The substance was not irritating to the skin of rabbits, but was found to be irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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.
Species:
rabbit
Strain:
not specified
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.
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1/24/1983 to 2/7/1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-like (QA signature), guideline study; restriction due to study being terminated prior to all effects had resolved.
Qualifier:
equivalent or similar to guideline
Guideline:
other: 16CFR 1500.42- Federal Hazardous Substances Act Regulations
Deviations:
no
GLP compliance:
yes
Remarks:
Study predates GLP regulations, but QA signature is available.
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Housing: The animals were housed and maintained in accordance with standards set forth in the Guide for the Care and Use of Laboratory Animals (DHEW Publication No. 80-23). 1 rabbit/cage (stainless steel with elevated wire mesh flooring).
- Diet (e.g. ad libitum): Wayne 15% Rabbit Ration was provided ad libitum
- Water (e.g. ad libitum): tap water was provided ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature: 60-75°F
- Humidity (%): 40-45%
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
Observation period (in vivo):
The eyes were examined and graded for ocular reaction at 1, 2, 3, 4, 7 and 14 days following instillation of test material into the eyes.
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing.

SCORING SYSTEM: Interpretation of the results was made in accordance with the Draize technique for scoring ocular lesions
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: All scores were 0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: all scores were 0
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.7
Max. score:
3
Reversibility:
not fully reversible within: 14d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritant / corrosive response data:
In a primary eye irritation study, 0.1 ml of undiluted test substance was placed into one eye of each of the rabbits (6 animals).
The mean Draize scores (24, 48 and 72 h) were:
Cornea = 0
Iris = 0
Conjunctivae – redness = 1.7
Chemosis = 2.5
 
The test substance produced ocular irritation which was not cleared until day 14.

Draize Scores

Animal #

1

2

3

4

7

14

Conjunctivae-chemosis

 

 

 

 

 

 

1

3

3

3

2

1

1

2

4

2

2

2

1

1

3

2

2

1

1

1

1

4

4

3

3

3

3

1

5

2

2

1

1

1

1

6

3

2

3

2

1

1

Conjunctivae-redness

 

 

 

 

 

 

1

2

2

1

1

1

1

2

2

2

1

1

1

0

3

2

2

2

1

1

0

4

2

2

2

2

2

1

5

2

2

1

2

1

1

6

2

2

1

1

0

0

Cornea

 

 

 

 

 

 

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

4

0

0

0

0

0

0

5

0

0

0

0

0

0

6

0

0

0

0

0

0

Iritis

 

 

 

 

 

 

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

4

0

0

0

0

0

0

5

0

0

0

0

0

0

6

0

0

0

0

0

0
Interpretation of results:
irritating
Remarks:
Migrated information Category 2 Criteria used for interpretation of results: EU
Conclusions:
Tetrapropenyl succinic anhydride (TPSA) was tested for eye irritation in rabbits according to a US test guideline, comparable to the OECD 405. The substance is classified as irritating to the eyes according to Regulation EC No. 1272/2008.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Tetrapropenyl succinic anhydride was tested in guideline protocols for skin and eye irritation. The substance was not irritating to the skin of rabbits. This is different than the behaviour of other C8 -12 alkenyl succinic anhydride category members, which demonstrated skin irritation.

Two studies were performed on eye irritation. An early study indicated that the substance did not result in eye irritation. A later study, using the same protocol (Draize evaluation scale), demonstrated conjunctival irritation (but no corneal damage or iritis) which did not fully resolve for 14 days. The level of irritation progressively diminished throughout the study, but it was not carried out to 21 days. The reason for the differences are not clear, but could involve differences in the test material. As the anhydride rapidly hydrolyses in water, the corresponding dioic acid is generated and is likely responsible for ocular irritation. The substance is evaluated as irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
Experimental study by guideline method

Justification for selection of eye irritation endpoint:
Experimental study by guideline method

Effects on eye irritation: irritating

Justification for classification or non-classification

The substance is not irritating to the skin in a guideline study, and so is not classified. The substance resulted in eye irritation which did not fully resolve in the 14 days duration of the test. The substance is classified as irritating to the eye, Category 2, according to Regulation EC No. 1272/2008, as amended by Regulation EC No. 286/2011.