Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 932-121-8 | CAS number: 1147459-12-8
- 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
Corrosive properties are observed following exposures of 3 minutes and longer to the skin of rabbits, with skin destruction becoming visible the next day.
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
- Study period:
- 15 to 16 December 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was generally compliant with OECD Guidelines and was conducted in accordance to GLP. Some deviations were noted in relation to pre-test determination of ph, acid reserve capacity and also in relation to evaluation of the results. The early termination of the sole rabbit exposed may have been premature for a realistic assessment of dermal reactions
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Animal temperature room was lower than recommended in the guidelines.
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Grimaud Frères Sélection S.A.S., La Corbière, Roussay, France.
- Age at study initiation: 4 to 6 months old
- Weight at study initiation: 3.552kg
- Housing: The animal was housed individually in individual Pajon cages (50 cm x 57 cm x 75 cm).
- Diet (e.g. ad libitum): During the study, the animal had free access to 110C pelleted diet
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h (7:00 - 19:00)
IN-LIFE DATES: From: 15 To:16 December 2009 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- Single exposure for 3 minutes
- Observation period:
- 2 days
- Number of animals:
- one animal
- Details on study design:
- TEST SITE
- Area of exposure: Two areas on the anterior and posterior parts of each flank (approximately 3.5 x 5 cm).
- % coverage: No information provided
- Type of wrap if used: non-irritating semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes - any residual test item was wiped off by means of a moistened cotton pad.
- Time after start of exposure: Following removal of the dressing. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- >= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Due to the severe cutaneous reactions, the study was considered complete and was terminated on the second day.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- >= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Due to the severe cutaneous reactions, the study was considered complete and was terminated on the 2nd day.
- Irritation parameter:
- other: Scabs
- Basis:
- animal #1
- Time point:
- 24 h
- Reversibility:
- no data
- Remarks on result:
- other: Scabs were evident at the 24 hour time-point. Due to the severe cutaneous reactions observed, the study was considered complete and was terminated on the 2nd day.
- Irritant / corrosive response data:
- A very slight erythema (grade 1) was noted on day 1, 1 hour after removal of the dressing. On day 2, severe erythema and oedema (grade 4) and scabs were observed on the treated flank. Additionally, a brownish area was noted during the observation. As a result of the presence of these cutaneous reactions, the study was considered complete and the animal was sacrificed on day 2.
- Other effects:
- No additional effects.
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In vivo study of Coco amidopropyldimethylamine for skin corrosion showed that a 3 minute exposure to rabbit skin lead over the course of one day to the development to skin corrosion.
- Executive summary:
Coco amidopropyldimethylamine was assessed for its ability to cause corrosion in a in vivo skin corrosion/irritation study in New Zealand White rabbits (OECD 40). The test item was applied undiluted at a concentration of 0.5 ml for period of 3 minutes to one male New Zealand White rabbit. The test item was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour and 24 hours after removal of the dressing.
A very slight erythema was noted on day 1, 1 hour after removal of the dressing. On day 2, severe erythema and oedema and scabs were observed on the treated flank. Additionally, a brownish area was noted during the observation. According to these severe cutaneous reactions, the study was considered complete and the animal was prematurely sacrificed for ethical reasons on day 2.
Under the conditions of the study, the test substance, Coco amidopropyldimethylamine, was considered to be corrosive when topically applied to rabbits. In accordance with CLP Regulation 1272/2008, the test substance should be classified as Category 1 B corrosive substance with the signal word Danger and the hazard statement "H314: Causes severe skin burns and eye damage" associated with it.
Reference
Clinical examinations were made at least once daily for signs of mortality or moribundity. Body weight was weighed on the day of test item administration.
Dermal Irritation |
Scores |
Mean Irritation Score |
|||
|
1 hour Day 1 |
24 hours Day 2 |
48 hours Day 3 |
72 hours Day 4 |
|
Erythema |
1 |
4 |
- |
- |
4.0 |
Oedema |
0 |
4 |
- |
- |
4.0 |
Other |
* |
A |
- |
- |
- |
* = none
A = scabs
- = animal sacrificed on Day 2 for ethical reasons.
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
In vitro Skin Irritation/Corrosion:
The potential corrosivity of Coco amidopropyldimethylamine was evaluated in an in vitro Reconstituted Human Epidermis Model (OECD 431). The EPISKIN model was used to distinguish between corrosive and non-corrosive chemicals. Duplicate tissues were treated with the test material for 3, 60 and 240 minutes. At the end of the exposure period, the test material was rinsed from each tissue before MTT-loading. Following this, a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazon crystals out of MTT loaded tissues. Following extraction, each tube was mixed thoroughly and duplicate 200µl samples were transferred to the appropriate wells of a pre-labelled 96-well plate. Optical density was measured at 540 nm and data was presented in the form of percentage viability. Following the 3, 60 and 240 minutes exposure, the relative mean viability of the test material treated tissues were 88.7%, 74.8% and 93.1% respectively. Under the conditions of this study, the test material was considered to be non-corrosive.
However, available data obtained with cationic surfactants have shown that these RhE based tests do not provide reliable results, as proven with the available in vivo study on Coco amidopropyldimethylamine, and thus results from this study are not taken into consideration for classification.
In vivo Skin Irritation/Corrosion:
Coco amidopropyldimethylamine was assessed for its ability to cause corrosion in an in vivo skin corrosion/irritation study in New Zealand White rabbits (OECD 404). The test item was applied undiluted at a concentration of 0.5 ml for period of 3 minutes to one male New Zealand White rabbit. The test item was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour and 24 hours after removal of the dressing.
A very slight erythema was noted on day 1, 1 hour after removal of the dressing. On day 2, severe erythema and oedema and scabs were observed on the treated flank. Additionally, a brownish area was noted during the observation. According to these severe cutaneous reactions, the study was considered complete and the animal was prematurely sacrificed for ethical reasons on day 2.
Under the conditions of the study, the test substance, Coco amidopropyldimethylamine, was considered to be corrosive when topically applied to rabbits.
Justification for classification or non-classification
Available data indicate corrosive properties following exposures of 3 minutes and longer. Following exposure of 3 minutes, the skin destruction is observed at examination the next day, but not yet at the observation 1 hour after the exposure.Consequently, GHS classificationCorrosive Category 1Bis appropriate, with hazard statement H314: Causes severe skin burns and eye damage.
Due to corrosive properties demonstrated in the dermal irritation/corrosion study with this substance, testing in eyes is not justified. Under GHS with the hazard phrase ‘H314 Causes severe skin burns and eye damage’ additional classification for eyes is not necessary.
There is no information is available following exposure via inhalation. However, with a vapour pressure of 3.96 x 10-5 Pa at 25 °C (EpiWin), potential for inhalation of vapours is limited.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, and classificationSTOT-SE Cat.3 for respiratory irritationis not required.
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.