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EC number: 292-564-1 | CAS number: 90640-45-2
- 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
Endpoint summary
Administrative data
Description of key information
Results of reserve alkaline test and testing conducted on analogue compounds lead to classify Amines, C16 -22 -alkyltrimethylenedi- as corrosive to the skin cat. 1B. and for serious eye damage cat.1.
Exposure to via the inhalation route will be unlikely to occur. Consequently, despite the irritant nature of the substance, respiratory irritation is not expected
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The method used in the study which permits the measurement of pH and Alkaline reserve to identify chemicals potentially corrosive to the skin and to the eye was described in V.Froment (1993) and JF.Regnier & C. Imbert (1992), respectively.
- GLP compliance:
- yes (incl. QA statement)
- Strain:
- not specified
- Irritation / corrosion parameter:
- other: Physical-chemical index (I) corrected
- Value:
- 12.55
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Irritation / corrosion parameter:
- other: log R corrected
- Value:
- 1.15
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Irritation / corrosion parameter:
- other: pH
- Value:
- 11.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- corrosive
- Conclusions:
- The test item can be considered as potentially corrosive to the skin and severely irritant to the eye
- Executive summary:
The acid/alkaline reserve method can be used at first step of stepwise strategy for assessing cutaneous and ocular irritation.
An amount of the test substance is added to distilled water in a beaker. The solution or suspension is maintained for 4 hours with agitation at 37° C. The pH is directly measured and the sample is then titrated with hydrochloric acid until neutrality is obtained. The acidic or alkaline reserve (R) is expressed as the number of grams of pure acid or base necessary to neutralise 100 g of product (%).
A preliminary titration was performed for a preliminary test to allows good conditions for the alkaline reserve (R) determination: 10 mL volume of a 100 g/L solution are neutralised by approximately 95 mL of 0.5 N HCl. Then for a definitive test, the titration were performed three times more in the same conditions.
Under the test conditions, the aqueous test substance shows an basic character demonstrated by a pH of 11.40 for a 100 g/L solution in water, an alkaline reserve of 14.18 (i.e log R = 1,15) and a physicochemical index of 12.55.
According to the method described, as all the criteria are fulfilled, the test item can be considered as potentially corrosive to the skin and severely irritant to the eye.
Reference
Under the test conditions, the aqueous substance shows a basic character demonstrated by a pH of 11.40 for a 100 g/L solution in water, an alkaline reserve of 14.18 (i.e log R = 1,15) and a physicochemical index of 12.55.
Table 1 : Results of neutralization experiments
Replicate | Dinoram 42 100 g/L, mL | HCl 0,5 N, mL | Initial pH | Final pH | Rcorrected | Log (R) corrected | I |
1 | 20 | 14.355 | 11.40 | 7.00 |
14.18
| 1,15 | 12.55 |
2 | 20 | 14.100 | 11.40 | 7.00 | |||
3 | 20 | 13.500 | 11.40 | 7.00 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Reserve alkaline test
The dermal and ocular irritant potential of Amines, N-C16-22-alkyltrimethylenedi- was assessed using a non-animal testing based on alkaline reserve according to the method described in the two references : JF.Regnier and C.Imbert (1992), and V.Froment (1993).
This method can be used at first step of stepwise strategy for assessing cutaneous and ocular irritation.
An amount of the test substance is added to distilled water in a beaker. The solution or suspension is maintained for 3 hours with agitation at 37° C. The pH is directly measured and the sample is then titrated with diluted sodium hydroxyde or hydrochloric acid until neutrality is obtained. The acidic or alkaline reserve (R) is expressed as the number of grams of pure acid or base necessary to neutralise 100 g of product (%).
Under the test conditions, the aqueous Amines, N-C16 -22 -alkyltrimethylenedi- shows a basic character demonstrated by a pH of 11.40 for a 100 g/L solution in water, an alkaline reserve of 14.18 (i.e log R = 1.15) and a physicochemical index of 12.55.
According to the method described, as all the criteria are fullfilled, Amines, C16 -22 -alkyltrimethylenedi- can be considered as potentially corrosive to the skin and severely irritant to the eye.
All available data on the category of the diamines, indicate that all other besides this hydrogenated tallow-diamine are corrosive to skin, and classified as corrosive Cat. 1B (See table):
C12-14, Coco, Oleyl: as can be seen, C12-14, Coco and Oleyl diamines are all corrosive following 3 minute exposures, with in depth skin destruction only becoming visible at 24 hr readings, resulting to Cat.1B classification.
Tallow: for the Tallow, the 3 minute exposures do not lead to corrosion, but as the 1 hr exposure leads to corrosion, it still classifies as Cat. 1B. The Tallow seems to be a little less corrosive compared to the shorter chains and Oleyl. Unfortunately this substance has not been included in the BSL testing program at the time, so direct comparison of results is a bit less clear. It should be remarked that contrary to the recent BSL studies, the skin was decontaminated immediately after exposure. However, the same was done in the CESIO studies at SPL for Coco where the 3 minute exposures still resulted to corrosion.
HT: contrary to the other diamines the HT is not corrosive, but severely irritating. However, in view of the overall information on the category of alkyl-diamines, it is best to take care to limit possible dermal exposures.
Chain | Class | Study | Result |
C12-14 | Cat. 1B | BSL 073802C, 2008 | 3 min: Corrosive after 24 hrs |
Coco | Cat. 1B | BSL 073802B, 2008 | 3 min: Corrosive after 24 hrs |
| Cat. 1B | SPL 1594-191/1-18, 1989 | 3 min: Corrosive (skin decontaminated) effects indicative for corrosion were visible from 24 hours; 1/6 animals showed scar after 14 days |
| Cat. 1B | SPL, Cesio, 1991 | 3 min: Corrosive (skin decontaminated) Scar tissue in 3/6 animals after 14 days, effects indicative for corrosion were visible from 24 hours |
| n.a. | F&D Res.Lab, SD-1684, 1981 | 24 hrs: Corrosive (Eschar formation (dead skin) visible at 24 and 72 hrs. No later observations) |
Oleyl | Cat. 1B | BSL 073802E, 2008 | 3 min (liquid/paste): Corrosive after 24 hrs |
| Cat. 1B | BSL 073802A, 2008 | 3 min (liquid): Corrosive after 24 hrs |
| Cat. 1B | CIT 19300 TAL, 2000 | 3 min (liquid): Corrosive (Crusts tissue from 24 hrs) |
Tallow | Cat. 1B | SPL 116/28, 1987 | (Diamine BG) 3 min: Irritant (skin decontaminated) 1 hr: Corrosive |
| Cat. 1B | SPL 1594-191/1-18, 1989 | 3 min: Irritant (skin decontaminated) 1 hr: Corrosive |
| n.a. | SPL, Cesio, 1991 | 3 min: Irritant (skin decontaminated) |
HT | Cat. 2 | BSL 073802D, 2008 | 4hr: Strongly irritating. Eschar formation was observed after 24h (animal 1) or after 48h (animal 2 and 3), fully reversible by day 9 or 14. |
| Cat. 2 | SPL 116/37, 1988 | 4hr: Irritating: at end of observation: dry straw-coloured |
Eye irritation:
Due to the corrosive response expected on skin it is not ethical to carry out an animal study. In view of the severe reactions to skin, serious eye damage is to be expected.
Respiratory irritation:
Amines, N-C16 -22 -alkyltrimethylenedi- is a solid (pellets) with mp of 48°C and has a vapour pressure less than 0.0015 Pa at 20°C (value based on read-across from shorter chain C12-14-diamine). Also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Consequently, despite the irritant nature of the substance, respiratory irritation is not expected.
Justification for classification or non-classification
The results of reserve alkaline test indicate that Amines, C16 -22 -alkyltrimethylenedi- can be considered as potentially corrosive to the skin and severely irritant to the eye. The available studies for N-(hydrogenated tallow alkyl) trimethylenediamine (CAS 68603-64-5) show that this substance should regarded as a severe irritant as eschar formation (reversible) was observed in all treated animals. Consequently, a GHS classification corrosive Cat.1B. is appropriate for Amines, C16 -22 -alkyltrimethylenedi-, with hazard statement H314: Causes severe skin burns and eye damage.
In view of the severe irritant properties, it is prudent to classify the substance for serious eye damage Cat. 1, with hazard statement H318: Causes serious eye damage.
STOT-SE Cat.3 for respiratory irritation is not required. Exposure to via the inhalation route will be unlikely to occur. Consequently, despite the irritant nature of the substance, respiratory irritation is not expected
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