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Administrative data

Description of key information

Skin irritation: irritating
Eye irritation: corrosive

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:
1984-09-04 to 1984-09-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP without deviations.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
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
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The registered substance is considered to be skin irritating.
Executive summary:

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. The average values of erythema and edema scores at time points of 12, 48 and 72 h after treatment are 1.6 and 1.1, respectively. In addition, Skin dry, brittle and scaly were observed after 14d. Based on these findings, the registered substance is 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:
experimental study
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: 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.
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 the test item 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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The skin irritating potential of tripropenyl succinic anhydride was investigated according to test guideline 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. Therefore, the test item is considered to be skin irritating.

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.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the available data, it is concluded that tripropenyl succinic anhydride is subject to classification and labeling according to Directive 67/548/EECand Regulation 1272/2008/EC regarding skin/eye irritation/corrosion. The registered substance is classified as R38 and Cat. 2 (H315: cause skin irritation) for skin irritation, R41 and Cat. 1 (H318: causes serious eye damage) for eye irritation/corrosion.