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EC number: 247-781-6 | CAS number: 26544-38-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
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
- 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.
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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. - 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.
Reference
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 |
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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