Pentapropenyl succinic anhydride

Endpoint summary

Description of key information

Skin irritation (one study on the read-across supporting substance tripropenyl succinic anhydride): irritating
Eye irritation (one study on the read-across supporting substance tripropenyl succinic anhydride): corrosive

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Justification for read-across: The tested substance is strucrally related to the target chemical, exhibiting same chemical fuctional groups. It is assumed that the tested substance and the target substance share the same toxic mode of action. Justification for reliability: Guideline study according to GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species: Albino New Zealand rabbits
Origin: Hoechst AG, Kastengrund, conventional breeding
Number of animals: 3
Identification of animals: numbered ear tags
Animal weight: 3,1 - 3,8 kg
Animal husbandry: in fully air-conditioned rooms in individual cages (battery cages)
Room temperature: 20 ± 2 °C
rel. Humidity: 55 ± 10%
Light time: 12 hours a day
Food: Altromin 2123 maintenance diet - Rabbits; Altromin GmbH, Lage / Lippe, ad libitum
Water: deionized, chlorinated water from automatic drinkers, ad libitum

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0,5ml

Duration of treatment / exposure:

4h

Observation period:

14d

Number of animals:

3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

1.6

Max. score:

2

Reversibility:

fully reversible within: 14d

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

1.1

Max. score:

1.7

Reversibility:

fully reversible within: 14d

Other effects:

Skin dry, brittle and scaly after 14d

The analogue approach using tripropenyl succinic anhydride as source chemical is justified (target chemical: pentapropenyl succinic anhydride; source chemical: tripropenyl succinic anhydride):

The target chemical belongs to the homologues series of higher alkenyl succinic anhydride (ASA), where there is different number of propyl units. Therefore, it can be assumed that target chemical and other ASA member (tripropenyl succinic anhydride) share the same toxic mode of action.

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The target chemical is considered to be skin irritating.

Executive summary:

The skin irritating potential of pentapropenyl succinic anhydride was assessed base on the read-across approach using tripropenyl succinic anhydride as read-across supporting substance.

The skin irritating potential of tripropenyl succinic anhydride was investigated according to test guidline OECD 404. Very slight to well-defined erythema and very slightly to moderate edema were seen on during the observation period. All the effects were fully reversible. In addition, Skin dry, brittle and scaly were observed after 14d. Based on these findings, the test item tripropenyl succinic anhydride is considered to be skin irritating according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Likewise, the target chemical pentapropenyl succinic anhydride is also considered to be skin irritating.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1981-02-02 to 1981-02-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Justification for read-across: The tested substance is strucrally related to the target chemical, exhibiting same chemical fuctional groups. It is assumed that the tested substance and the target substance share the same toxic mode of action. Justification for reliability: Well performed study under GLP

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.9-2.5 kg
- Housing: individual cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Vehicle:

other: PEG 400

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 1%, 10% and 100%

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1, 7, 24, 48, 72 h after application

Number of animals or in vitro replicates:

2 per dose

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline solution
- Time after start of exposure: 24 h

SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: fluorescein sodium of 0.01%

Irritation parameter:

other: overall effect

Basis:

other: animals of 100% group

Time point:

other: no data

Reversibility:

not reversible

Remarks on result:

other: see Irritant/corrosive response data in the following

Irritant / corrosive response data:

100% group: Light corneal cloudiness was observed. The conjunctiva showed a diffuse carmine to fleshy redness and a marked swelling with partial retraction of eyelids. The treated eye had severe discharge.
10% group: Light corneal cloudiness was observed. The blood vessels of the conjunctiva were injected. Severe discharge was observed. All the effects were reversible exept for the light redness and swelling.
1% group: The treated animal showed significantly injected blood vessels and slight discharge. These findings were reversible in 48 hours.

The analogue approach using tripropenyl succinic anhydride as source chemical is justified (target chemical: pentapropenyl succinic anhydride; source chemical: tripropenyl succinic anhydride):

The target chemical belongs to the homologues series of higher alkenyl succinic anhydride (ASA), where there is different number of propyl units. Therefore, it can be assumed that target chemical and other ASA member (tripropenyl succinic anhydride) share the same toxic mode of action.

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

It is concluded that the test substance may cause serious eye damage.

Executive summary:

The eye irritation/corrosion potential of pentapropenyl succinic anhydride was assessed base on the read-across approach using tripropenyl succinic anhydride as read-across supporting substance.

The eye irritation/corrosion potential of tripropenyl succinic anhydride was investigated using Albino Himalaya rabbits. The test item of 1, 10 and 100% was applied by instillation of 0.1 ml into the left eyes of each 2 animals. The effects were observed after 1, 7, 24, 48 and 72 hours after application. After 24 hours, the treated eyes were washed with physiological saline solution. Light to severe effects were observed in all the treated groups. In the 100% group light corneal cloudiness was observed. The conjunctiva showed a diffuse carmine to fleshy redness and a marked swelling with partial retraction of eyelids. The treated eye had severe discharge. All the effects were irreversible during the observation period. In the 10% group, light corneal cloudiness was observed. The blood vessels of the conjunctiva were injected. Severe discharge was observed. All the effects were reversible exept for the light redness and swelling. In the 1% group, the treated animal showed significantly injected blood vessels and slight discharge. These findings were reversible in 48 hours. Based on the effects observed, it is concluded that the test substance may cause serious eye damage.

Likewise, the target chemical pentapropenyl succinic anhydride may also cause serious eye damage.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The skin and eye irritation/corrosion potential of pentapropenyl succinic anhydride was assessed base on the read-across approach using tripropenyl succinic anhydride as read-across supporting substance.

The skin irritating potential of tripropenyl succinic anhydride was investigated according to test guidline OECD 404. Very slight to well-defined erythema and very slightly to moderate edema were seen on during the observation period. All the effects were fully reversible. In addition, Skin dry, brittle and scaly were observed after 14d.

Likewise, the target chemical pentapropenyl succinic anhydride is also considered to be skin irritating.

The eye irritation/corrosion potential of pentapropenyl succinic anhydride was assessed base on the read-across approach using tripropenyl succinic anhydride as read-across supporting substance.

The eye irritation/corrosion potential of tripropenyl succinic anhydride was investigated using Albino Himalaya rabbits. The test item of 1, 10 and 100% was applied by instillation of 0.1 ml into the left eyes of each 2 animals. Light to severe effects were observed in all the treated groups. In the 100% group light corneal cloudiness was observed. The conjunctiva showed a diffuse carmine to fleshy redness and a marked swelling with partial retraction of eyelids. The treated eye had severe discharge. All the effects were irreversible during the observation period. Based on the effects observed, it is concluded that the test substance may cause serious eye damage.

Likewise, the target chemical pentapropenyl succinic anhydride may also cause serious eye damage.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the available data, pentapropenyl succinic anhydride is considered to be skin irritating (Cat. 2) and may cause serious eye damage (Cat. 1) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).