Pentapropenyl succinic anhydride

Eye irritation

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pentapropenyl succinic anhydride

Cas Number:

78683-74-6

Molecular formula:

R-C4H3O3 , whereas R=C12-C18-alkyl-(branched, unsaturated)

IUPAC Name:

Pentapropenyl succinic anhydride

Test animals / tissue source

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

Test system

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%

Results and discussion

In vivo

Results

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.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.