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EC number: 413-800-3 | CAS number: 87787-81-3 STEPAN TAB -2
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 19,1990 to March 15, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to good laboratory practices, and according to a recognized guideline. However, the exact guideline designation was not given, and the test substance purity and batch were not disclosed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EPA Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), The Toxic Substances Control Act (40 CFR), and the OECD Guidelines.
- Deviations:
- no
- Remarks:
- Study report stated there were no deviations.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 87787-81-3
- EC Number:
- 618-070-1
- Cas Number:
- 87787-81-3
- IUPAC Name:
- 87787-81-3
- Reference substance name:
- A mixture of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid; dihydrogenated alkyl (C14-C18)amine
- EC Number:
- 413-800-3
- EC Name:
- A mixture of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid; dihydrogenated alkyl (C14-C18)amine
- Cas Number:
- 87787-81-3
- Molecular formula:
- C44H79NO3
- IUPAC Name:
- 2-(dioctadecylcarbamoyl)benzoic acid; 2-(ditetradecylcarbamoyl)benzoic acid; 2-[(propan-2-yloxy)carbonyl]benzoic acid; 2-[octadecyl(tetradecyl)carbamoyl]benzoic acid; 2-octadecyl-2,3-dihydro-1H-isoindole-1,3-dione; 2-tetradecyl-2,3-dihydro-1H-isoindole-1,3-dione; benzene-1,2-dicarboxylic acid; dioctadecylamine; ditetradecylamine; octadecyl(tetradecyl)amine
- Reference substance name:
- reaction mass of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid dihydrogenated alkyl (C14-C18)amine
- IUPAC Name:
- reaction mass of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid dihydrogenated alkyl (C14-C18)amine
- Reference substance name:
- Stepan TAB-2
- IUPAC Name:
- Stepan TAB-2
- Details on test material:
- The test material was designated as Stepan Agent X1401-91, which is an off white waxy solid of undesignated purity. The test substance was stored at room temperature throughout the study in a clear, colorless glass jar with a black plastic lid.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young adult New Zealand White rabbits (five male and five female) weighing between 2984 and 3607 grams at the start of the study.
All animals were acclimated to the laboratory for at least four days before the study. Animals were housed singly in wire mesh suspension cages and fed Purina Laboratory Rabbit Chow or other comparable diet, and tap water ad libitum. The animals were obtained on a 12-hour light/12-hour dark cycle. Cage cards and individual ear marks or tags were used to identify each rabbit.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Details on dermal exposure:
- This study was designed to examine the potential lethality of a single pre-selected dermal dose of test material (2.0 ;/kg).
Shortly prior to dosing the hair of each rabbit was closely clipped from the ventral area of the trunk using an electric clipper, so as to expose at least 10% of the body surface area. Animals were weighed shortly before dosing, in order to calculate doses.
The sample (3.0 ml physiological saline water vehicle) was applied at the selected dose to five male and five female rabbits. The test material was applied directly to the intact skin of the animal or to a sleeve of rubber dental dam, which was wrapped around the animal and secured with staples. An outer layer of porous gauze dressing was wrapped around the trunk of the animal and secured with tape. The animal was then fitted with an appropriate restraining device to prevent removal of the wrapping. The time of application was recorded.
At the end of the approximate 24-hour exposure period, the wrapping was removed and any unabsorbed sample removed by gentle sponging using a towel moistened with water or other appropriate solvent. The presence or absence of sample residue on the wrapping and on the rabbits was documented. - Duration of exposure:
- 24 hours
- Doses:
- 2g/kg bw
- No. of animals per sex per dose:
- Five males and five females per dose.
- Control animals:
- no
- Details on study design:
- Animals were observed for signs of toxicity and behavioral changes once on the day of treatment. Observations were more frequent if clinical signs were present. All surviving rabbits were maintained for at least 14 days following exposure. Examinations for gross signs of toxicity were carried out once daily with an additional check for viability during the day. Observations were made for erythema, edema, atonia, desquamation, necrosis, coriaceousness, fissuring and for other evidence of irritation or injury once daily. All appropriate observations and observation times were documented.
Body weight was measured for each animal on the day of dosing (just prior to dosing), at necropsy on animals which did not survive the observation period, on Day 7 and Day 14 at necropsy.
Gross necropsies were performed on each animal that dies. At the end of the 14-day observation period the surviving rabbits were weighted, sacrificed, and a gross necropsy was performed on each animal.
The study report included identification of animals, test procedure, protocol deviations if any, description of the test material, dose level, body weight data, tabulation of mortalities, clinical in-life observations, necropsy observations, and dermal observations. - Statistics:
- No details provided.
Results and discussion
- Preliminary study:
- No preliminary study was conducted.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Slight to moderate erythema was observed in some animals, as well as slight edema, atonia and desquamation. These effects were observed on Days 1-8 and up to Day 11 in some animals, but generally tapered off after about Day 5. Nasal discharge and fecal s
- Gross pathology:
- No significant effects observed.
- Other findings:
- No additional findings not provided above.
Any other information on results incl. tables
Table 1: Body Weight Data in Male and Female Rats Treated Dermally with Stepan Agent x1401-91
|
|
Body Weight (g) |
|
||
Animal No. |
Sex |
Day 0 |
Day 7 |
Day 14 |
Body weight Change Day 0-14 (g) |
1-442 |
M |
3088 |
3194 |
4306 |
118 |
2-443 |
M |
3218 |
3383 |
3441 |
223 |
3-445 |
M |
3157 |
3225 |
3380 |
223 |
4-446 |
M |
3174 |
3297 |
3420 |
246 |
5 -454 |
M |
2984 |
3067 |
3164 |
180 |
Mean (S.D.) |
|
3124 (91) |
3225 (114) |
3322 (128) |
198 (51) |
|
|
|
|
|
|
6 -460 |
F |
3219 |
3309 |
3602 |
383 |
7 -461 |
F |
3291 |
3387 |
3573 |
282 |
8 -475 |
F |
3349 |
3462 |
3730 |
381 |
9 -476 |
F |
3381 |
3461 |
3365 |
-16 |
10-477 |
F |
3607 |
3703 |
3923 |
216 |
Mean (S.D.) |
|
3369 (146) |
3464 (148) |
3619 (174) |
249 (164) |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: US EPA pesticides
- Conclusions:
- Under the conditions of the study, the dermal LD50 value for Stepan Agent X1401-91 was determined to be >2 g/kg bw in the New Zealand White Rabbit.
- Executive summary:
The acute dermal toxicity of Stepan Agent X1401 -91 was evaluated in a limit test in compliance with the protocols specified in the Federal Insecticide, Fungicide and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR) and the OECD Guidelines.
No deaths occurred during the observation period. Any clinical changes and /or irritative effects or gross necropsy findings observed during the observation period or following sacrifice were documented in the study report. The acute dermal LD50 was determined to be > 2.0 g/kg body weight in the male and female New Zealand White rabbits tested.
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