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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
The oral LD50 in rats was 2.9 g/kg, and the dermal LD100 was > 6.2 g/kg in rabbits. The dermal LD50 is less than 6.2 g/kg, and is estimated to be > 2.0 g/kg. An acute inhalation toxicity study, LC50 > 5.3 mg/L, is read-across from a category member, nDDSA.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study by GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Preceeds GLP guidance, but QA signature is available.
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Sherman-Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: weighing between 200 and 300 gm
- Fasting period before study: The rats were deprived of food but not water for 24 hours prior to dosing.
- Housing:
- Diet : ad libitum
- Water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 1.0 gm/kg
2.0 gm/kg
4.0 gm/kg
8.0 gm/kg
16.0 gm/kg - No. of animals per sex per dose:
- Five groups of 5 males
- Control animals:
- no
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2.9 other: g/kg
- Based on:
- test mat.
- 95% CL:
- > 2 - < 4
- Mortality:
- Group (g/kg) Motality
1.0 0/5
2.0 0/5
4.0 5/5
8.0 5/5
16.0 5/5 - Clinical signs:
- other: No untoward symptoms were observed at 1.0 gm/kg. At 2.0 gm/kg the animals were lethargic and oily looking for up to 48 hours. At 4.0 gm/kg the animals were severely depressed after 4 hours and semi-comatose within 12 hours. Death occurred within 72 hour
- Gross pathology:
- Gross pathologic examination revealed nothing remarkable.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Tetrapropenyl succinic anhydride (TPSA) was tested in rats for acute oral toxicity according to an OECD 423 protocol. THe LD50 was 2.9 g/kg bw or 2900 mg/kg bw. The substance is not classified according to Regulation EC No. 1272/2008.
- Executive summary:
In an acute oral toxicity study, 5 groups fasted Sherman-Wistar strain Albino rats (five male/group) were given a single oral dose of test material at a dose level of 1.0, 2.0, 4.0, 8.0 and 16.0 g/kg bw and observed for14 days.
No untoward symptoms were observed at 1.0 gm/kg. At 2.0 gm/kg the animals were lethargic and oily looking for up to 48 hours. At 4.0 gm/kg the animals were severely depressed after 4 hours and semi-comatose within 12 hours. Death occurred within 72 hours. At 8.0 gm/kg and 16.0 gm/kg the animals were semi-comatose after 4 hours and subsequently died within 12-48 hours. All survived animals showed expected bodyweight gain during the study period.
The oral LD50 value of test material in male Sherman-Wistar rats has been determined to be 2.9 g/kg bodyweight, with 95% confidence intervals of 2.0-4.0 g/kg bodyweight.
Reference
Test Results
Dose Level (g/kg) |
# of animals dosed |
Motalities |
Total dead 14 days |
Total survived 14 days |
Initial weight (g) |
Final weight (g) |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||||||
1 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
215 |
250 |
2 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
235 |
255 |
4 |
5 |
0 |
2 |
3 |
|
|
|
|
|
|
|
|
|
|
5 |
5 |
0 |
240 |
|
8 |
5 |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
5 |
5 |
0 |
240 |
|
16 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
|
|
5 |
5 |
0 |
200 |
|
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 900 mg/kg bw
- Quality of whole database:
- adequate
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Assume guideline study, no information on GLP. No information is available on the method.
- Qualifier:
- according to guideline
- Guideline:
- other: no information
- Principles of method if other than guideline:
- No information on method, as found in a secondary source reported to the U.S. Environmental Protection Agency. It is assumed that the method was according to a current guideline.
- GLP compliance:
- no
- Test type:
- other:
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The administered aerosol consisted of 90% dodecenyl succinic anhydride and 10% ethyl alcohol. No further information provided.
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 4 h
- Concentrations:
- nominal chamber concentration - 5300 mg/m3, time-weighted measured concentration - 1220 mg/m3. The geometric mean particle size was 1.3 microns.
- No. of animals per sex per dose:
- No information
- Control animals:
- not specified
- Details on study design:
- This appears to be an acute inhalation assay, of 4 hours duration, with an observation period of 14 days. Survival is reported on day 15.
- Statistics:
- No information
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 5 300 mg/m³ air (nominal)
- Based on:
- not specified
- Exp. duration:
- 15 d
- Remarks on result:
- other: equivalent to 5.3 mg/l as a mist
- Mortality:
- 2/5 female rats died by the 2nd day post-exposure, and 2/5 male rats died by the 5th day post-exposure.
- Clinical signs:
- other: No information
- Body weight:
- No information
- Gross pathology:
- No information
- Interpretation of results:
- not classified
- Remarks:
- Migrated information The criteria for classification as Acute Toxicity Category 4 is ≤ 5.0 mg/L. Criteria used for interpretation of results: EU
- Conclusions:
- N-Dodecenyl succinic anhydride (nDDSA), as an aerosol, was tested in a four hour acute inhalation toxicity assay in rats. The LD50 was > 5.3 mg/L. This data suggests that nDDSA is not classified according to Regulation EC No. 1272/2008. Data can be read-across among members of the C8-12 Alkenyl Succinic Anhydrides Category, based on common functional groups, similar bread-down products and potency patterns among carbon-chain length. This is adequate to fulfill the information requirements, to be the basis for classification and labelling decisions, and for risk assessment.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 300 mg/m³ air
- Quality of whole database:
- minimal
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No information on method used. Precedes establishment of guidelines and GLP
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No internationally harmonized guideline available in 1969. Data obtained froma reliable textbook of toxicology. Practical handling experience has not resulted in the questioning of the overall accuracy of this data.
- GLP compliance:
- no
- Test type:
- other: standard method at the time
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on dermal exposure:
- no data provided
- Sex:
- not specified
- Dose descriptor:
- LD100
- Effect level:
- > 6 200 - < 7 500 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal lethal dose of Tetrapropenyl succinic anhydride (TPSA) in rabbits was reported to be 6200 to 7500 mg/kg. The substance is not classified.
Reference
The publication states that, although TPSA is not readily absorbed through the skin, the percutaneous lethal dose ranges from 6.2 to 7.5 grams/kg in rabbits.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- adequate
Additional information
Acute toxicity values for tetrapropenyl succinic anhydride (TPSA) were reported in a reliable textbook. The oral LD50 in rats was 2.9 g/kg, and this was found to be consistent with another C8 -12 Alkenyl Succinic Anhydride category member, linear C12 n-dodecenyl succinic anhydride (nDDSA), though less toxic than octenyl succinic anhydride (OSA). Read-across among the category members is substantiated by the fact that they have common functional groups and similar behaviour in physico-chemical and toxicity tests, as provided in the Chemical Category Report Format (CCRF) attached to the IUCLID file. The dermal toxicity values are not clear from the text: "the percutaneous lethal dose ranges from 6.2 to 7.5 grams/kg in rabbits." This could be interpreted to mean that the LD50 is between these values, or that the LD100 is between these values. If the LD50 is > 6.2 g/kg or 6200 mg/kg bw, then the substance is not toxic dermally. If the values are conservatively considered to be LD100 values, then the LD50 is less than 6.2 g/kg, and is estimated to be > 2.0 g/kg. This is consistent with nDDSA, and again slightly less toxic than OSA. Carbon chain compounds of a length of eight have been found to have higher dermal irritation effects than carbon chains of other lengths in dermal irritation tests (Sato, et al., 1999, Stillman, et al., 1975). This has been observed here with newly generated skin irritation data for OSA and nDDSA. Thus, the category data for the C8 -12 Alkenyl Succinic Anhydrides support the conclusion that the C12-TPSA has a low order of acute toxicity.
Justification for selection of acute toxicity – oral endpoint
experimental study in a reputable laboratory
Justification for selection of acute toxicity – inhalation endpoint
experimental study as reviewed by an authoritative regulatory body
Justification for selection of acute toxicity – dermal endpoint
Data reported in a reliable textbook. The data are interpreted to indicate that the LD100 was > 6.2 g/kg in rabbits. The LD50 is estimated to be > 2000 mg/kg bw.
Justification for classification or non-classification
Oral and dermal LD50 values for tetrapropenyl succinic anhydride are less than 2000 mg/kg bw, and the inhalation LD50 is less than 5 mg/L. These do not meet the criteria in Regulation EC No. 1272/2008 for classification for acute toxicity.
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