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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 20 to February 23, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted following good laboratory practices, and following recognized protocols. However, the exact protocol was not cited, and no data were provided concerning test sample purity and batch number.
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 and Toxic Substances Control Act protocol provided in 40 CFR
- Deviations:
- no
- Remarks:
- study report states no deviations occurred.
- GLP compliance:
- 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:
- Test material was identified as Stepan Agent X1401-91, an off-white waxy solid. The test sample was stored at room temperature throughout the study in a clear, colorless glass jar with a black plastic lid. The test substance batch number and purity was not noted in the report.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Young, healthy adult New Zealand White rabbits or either sex with healthy, intact skin were used.
All animals were acclimated to the laboratory for one day 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.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- 0.5 grams
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- Six animals
- Details on study design:
- On the day prior to the test the application sites were prepared by clipping the hair from the dorsal area of the rabbits. Test substance (0.5 g) moistened with of physiological saline water was applied to or under a small surgical gauze patch, approximately 1 inch x 1 inch, two layers thick to one intact skin area on each of the test rabbits. The application sites were rotated to minimize bias due to site-to-site variation. Each was held in place with tape. After application of the parches the trunk of each rabbit was loosely wrapped with rubber dental dam which was secured with staples. An outer layer of gauze and tape was placed around the trunk of each animal. Each animal was fitted with an appropriate restraining device to prevent patch and wrapping removal. Following approximately 4 hours of exposure, the rabbits were released from restraint and the wrapping and patches were removed. The test sites may be wiped free of residual test material by a gentle sponging using a towel moistened with water.
The application sites were scored for each rabbit approximately 1/2 to 1 hour, 24 hours, 48 hours, and 72 hours after removal of the patches according to the Draize Scale. Additional observations were made on a per animal basis to establish reversibility of irritation. The skin was also observed for evidence of tissue destruction or deep injury (e.g., narcosis).
The times of dose application, patch removal and 1/2 to 1, 24-, 48-, and 72-hour readings were recorded as well as the corresponding irritation scores.
The values for each rabbit were totaled and averaged for each of the following categories:
1: Erythema and eschar formation, intact skin, ½-1 hour; 2) Erythema and eschar formation, intact skin, 24 hours; 3) Erythema and eschar formation, intact skin, 48 hours; 4) Erythema and eschar formation, intact skin, 72 hours; 5) Edema, intact skin 1/2 to 1 hour 6) Edema, intact skin, 24 hours; 7) Edema, intact skin, 48 hours; 8) Edema, intact skin, 72 hours.
The eight average scores from above were added together and the results divided by four to obtain the Primary Irritation Index (PII).
When applicable, the following classification for rating of hazard potential (40 CFR 156, Proposed) was used:
1. Category I – Corrosive (tissue destruction dermis and/or scarring).
2. Category II – Severe irritation at 72 hours (severe erythema or edema).
3. Category III –Moderate irritation at 72 hours (moderate erythema.
4. Category IV - Mild or slight or no irritation at 72 hours (no irritation or slight erythema)
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 0.3
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- See Table.
Any other information on results incl. tables
Primary Skin Irritation in Rabbits Following a 4 -Hour Dermal Application of Stepan Agent X14901 -91
Skin Condition |
Reading |
Score for each Rabbita |
Total Score |
Average Score |
|||||
|
|
No. 1 |
No. 2 |
No 3 |
No.4 |
No.5 |
No.6 |
|
|
|
|
Erythma Formation |
|
|
|||||
Intact |
Site |
A |
B |
C |
D |
A |
B |
|
|
|
1.2 – 1 hour |
1 |
0 |
1H |
1 |
1H |
1H |
5 |
0.83 |
|
24 hours |
0 |
0 |
0H |
0 |
0H |
0H |
0 |
0.00 |
|
48 hours |
0 |
0 |
0H |
0 |
0H |
0H |
0 |
0.00 |
|
72 hours |
0 |
0 |
0H |
0 |
0H |
0H |
0 |
0.00 |
|
|
Edema Formation |
|
|
|||||
|
Site |
A |
B |
C |
D |
A |
B |
|
|
Intact |
1.2 – 1 hour |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0.17 |
|
24 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
|
48 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
|
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
Primary Irritation Index (PII) = 0.3
H = Hair on site
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: US EPA pesticides
- Executive summary:
The primary skin irritancy of Stepan Agent X1401 -91 was evaluated following test guidelines under the Federal Insecticide, Fungicide and Rodenticide Act (40 CFR), and the OECD Guidelines (Exact guideline not specified). No irritation persisted 72 hours following application. The Primary Irritation Index (PII) was found to be 0.3 based on erythema and edema. No changes in the coloration or texture of the skin were noted.. No evidence of corrosion (necrosis) was found.
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