Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-381-2 | CAS number: -
- 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
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Effects on respiratory irritation: irritating
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.2 kg - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: approx. 0.5 ml
- Concentration: undiluted - Duration of treatment / exposure:
- Dorsal skin: 1, 5, 15 minutes and 20 hours
Ear: 20 hours - Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal skin and ear
REMOVAL OF TEST SUBSTANCE
- Washing: Lutrol 50%
SCORING SYSTEM:
- similar to the table contained in OECD TG 404 - Time point:
- 48 h
- Reversibility:
- not reversible
- Remarks on result:
- other: necrosis
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Skin necrosis was seen 48 hours after contact to tridecylamine for 1 (1 out of 2 animals), 5 or 15 minutes or 20 hours.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- no
- Test system:
- human skin model
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test consists of a single topical exposure of the test substance to the surface of a human reconstituted epidermis model for 3 minutes and 1 hour followed by a cell viability test.
Cell viability is measured by dehydrogenase conversion of the yellow, water-soluble MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide) present in cell mitochondria into a blue formazan salt that is measured quantitatively after isopropanol extraction from the tissues. The optical density of the extracts of the tissues treated with the test substance is compared to negative control values from tissues treated with deionized water and is expressed as relative tissue viability.
Two EpiDerm TM tissues per exposure time were treated with 50 μL liquid test substance.
In case of direct MTT reduction, two freeze-killed control tissues (KC) per exposure time were treated additionally with each, the test item and the negative control, in the same way as the viable tissues.
Based on the result of the pretest, it was judged that application of killed control tissues is necessary.
Negative control (NC): Deionized water
Positive control (PC): 8 N potassium hydroxide solution
MTT reduction control (KC): Deionized water or test substance - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 µL liquid test substance
- Duration of treatment / exposure:
- 3 minutes, 1 hour
- Number of replicates:
- 2
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1st (3 minutes corrosion test)
- Value:
- 35.7
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1st (1 hour corrosion test)
- Value:
- 21
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2nd (3 minutes corrosion test)
- Value:
- 59.6
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2nd (1 hour corrosion test)
- Value:
- 14
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3rd (3 minutes corrosion test)
- Value:
- 31.5
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3rd (1 hour corrosion test)
- Value:
- 13.4
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Based on the results observed and by applying the evaluation criteria, it was concluded that Tridecylamine, branched and linear (TDA plus) shows a skin corrosion potential in the EpiDerm™ in vitro skin corrosion test under the test conditions chosen.
Referenceopen allclose all
Skin reactions:
After removal of the test substance, bleeding in the skin was observed after 1, 5, 15min exposure.
Time of exposure |
Findings after 24 h |
Findings after 8 days |
|
Dorsal skin |
1 min |
N+ |
N+/ N++ margin: ER++/ED++ |
5 min |
N+ |
N++/margin: ER++/ED++ |
|
15 min |
N+ |
N++/margin: ER++/ED++ |
|
20 h |
N+/margin: ER++/ED++ |
N++/margin: ER++/ED++ |
|
Ear |
20 h |
N+++ |
Mummification |
N = necrosis; ER = erythema; ED = edema; Ø = nonirritating; (+) = slight; + = distinct; ++ = severe; +++ = very severe
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- small volume of test substance (0.05 ml)
- GLP compliance:
- no
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean 2.9 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: second eye of the same animal treated with NaCl
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.05 ml
- Concentration: undiluted - Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- SCORING SYSTEM:
Eye reactions were scored similar to the table contained in OECD TG 405 - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 8 days
- Irritant / corrosive response data:
- Corrosion was noted 1 and 24 h after application as substantiated by severe reddening, very severe edema, and severe corneal opacity. Severe chemosis was noted after 8 days. Cornea could not be examined due to suppuration.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
Reference
Findings:
Findings after 1 hour |
Findings after 24 hours |
Findings after 8 days |
|
Test substance: |
Corrosion R+/ED+++/OP++ |
Corrosion R+/ED+++/OP++ |
ED++/severe suppuration; eyeball could not be evaluated |
NaCl: |
Ø |
Ø |
Ø |
R = redness; ED = edema; OP = opacity; Ø = nonirritating; (+) = slight; + = distinct; ++ = severe; +++ = very severe
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin Irritation:
Rabbits were exposed for 1, 5, 15min, or 20h to the registered substance (BASF 1970). After removal of the test substance, bleeding in the skin was observed (e.g. Petechia). Full-thickness skin necrosis was observed following 48h in all rabbits except one of two animals exposed for 1 minute, which showed only superficial necrosis until the end of the observation period of 8 days.
Tridecylamine, branched and linear (TDA plus) shows a skin corrosion potential in the EpiDerm™ in vitro skin corrosion test under the test conditions chosen (BASF SE, 2018).
Eye Irritation:
Severe reddening, very severe edema, and severe corneal opacity were noted in the rabbit eye at 1 and 24 hours after instillation of a small volume (0.05 ml) of an undiluted TDA. After 8 days, strong edema and suppuration did not allow examination of the eyes and the study was terminated for the sake of animal welfare (BASF AG, 1970).
Respiratory Tract Irritation
The sensory irritation potential of TDA was studied with the mouse bioassay following the method of the American Society for Testing and Materials (BASF AG, 1998; Val. 2). Groups of 4 male Swiss mice were exposed head-only to TDA (3.8, 7.7, 23 and 90 mg/m3) for 45 minutes, followed by a recovery phase of 15 minutes and a 7 day post-exposure observation period. Breathing patterns and frequency were recorded pre-exposure and during exposure in whole-body plethysmographs and the concentrations that produced a 50% decrease in frequency rates (RD50) during early, middle, and late 10-minute exposure intervals were calculated from the dose response. Clinical signs were only seen in the groups exposed to 23 or 90 mg/m³ (piloerection, poor condition of animals, and - at 90 mg/m3 only - labored breathing). The RD50s were calculated to be 525.6 mg/m3, 37.4 mg/m3 and 30.4 mg/m3 for the early, middle and late exposure periods, respectively. The respiratory depression was not fully reversible after the recovery phase at any of the tested concentrations. From the pattern of RD50 and the macroscopic lung findings in 2 mice exposed to 90 mg/m3 (focal red discoloration in some lobes of the lung), it was concluded that tridecylamine leads mainly to pulmonary irritation.
Justification for classification or non-classification
Based on the results of the skin and eye irritation testing, the test item is classified as skin corrosive cat. 1B (H314) and causes serious eye damage cat. 1 (H318) according to Regulation (EC) No 1272/2008 (CLP).
In mice, pulmonary irritation was observed in a study detecting respiratory depression. Additionally, acute inhalation caused irritation (bloody secretions from nose and eyes) in rats. Since no mortality occured, no signs of corrosion were described, and due to the low vapour pressure of the substance, which - in the absence of spray applications - limits exposure, classification for STOT SE 3 (irritation to the respiratory tract) is justified, but EUH 071 is not assigned.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
