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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Link to relevant study record(s)

Description of key information

Due to lack of quantitative data, absorption rates of 100% are indicated for all three routes. This basically indicates that, although the absorption is probably low, it is considered that no significant difference in absorption occurs between oral, dermal and inhalation route. Very likely this means an overestimation of the dermal absorption compared to oral route. Available studies do not indicate a concern for bioaccumulation.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential
Absorption rate - oral (%):
100
Absorption rate - dermal (%):
100
Absorption rate - inhalation (%):
100

Additional information

Physical-chemical properties

The test substance, N-[3 -(dimethylamino)propyl]-C12 -18(even numbered)-alkylamide or Cocoamidopropyldimethylamine has a molecular weight around 296 and is a light brown solid at 20°C. Its melting point is considered to be 23°C, the measured boiling point is > 300 at 1013 hPa and an estimated vapour pressure of 3.96 x 10-5Pa at 25°C (EPI suite) has been calculated. The octanol-water partition coefficient (log Pow) is considered to be 3.4 at 25°C on the basis of the calculated Log Kow value. The water solubility expressed as the critical micelle concentration (CMC, a solubility limit) since the substance forms micelles in water is 41 mg/mL at pH 7.0 at 25°C. In physiological circumstances the nitrogen will be positively charged, resulting to a cationic surfactant structure which leads to high adsorptive properties to negatively charged surfaces as cellular membranes. The apolar tails easily dissolve in the membranes, whereas the polar head causes disruption and leakage of the membranes leading to cell damage or lysis of the cell content. As a consequence, the whole molecule will not easily pass membrane structures. Cytotoxicity at the local site of contact through disruption of cell membrane will be considered the most prominent mechanism of action for toxic effects.

Data from acute toxicity studies and irritation studies

Acute toxicity was evaluated in an acute toxic class (OECD 423) study indicating a LD50 of 300 mg/kg bw. Mortality was observed at 2000 and 300 mg/kg on day 2 or 3. Hypoactivity or sedation, piloerection, dyspnea, hypersalivation, loud breathing, tonico-clonic convulsions and/or soft faeces were observed among the decedent or surviving animals. At necropsy, no apparent abnormalities were observed in any animal. The substance is corrosive when applied topically on rabbits and is not expected to easily pass the skin in view of its ionised form at physiological conditions. However, as this is not quantitatively evaluated, 100% dermal absorption is considered as worst case assumption.

Data from repeated dose toxicity studies

Oral:

Three oral repeated dose toxicity studies were performed with Coco amidopropyldimethylamine:

- Repeated Dose 28-Day Oral Toxicity in Rodents (OECD 407),

- Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD 422) and

- Repeated Dose 90-day Oral Toxicity Study in Rodents (OECD 408)

From these studies it can be concluded that:

- Overall there are low to no real systemic effects observed.

- NOAEL systemic effects: 60 mg/kgbw (based on decreased food intake and BW at 120 mg/kg, which probably is also secondary to the gastric effects)

- NOAEL local effects: 15 mg/kgbw (Although some minimal effects were observed in a few animals in thenon-glandular stomach, this is considered clinically irrelevant since humans do not have a forestomach equivalent)

 

The findings observed in these studies suggest that the toxicity of cocoamidopropyldimethylamine is rather expressed by local effects than systemic effects. This supports the lack of bio-accumulating potential of the substance.

 

Inhalation:

Cocoamidopropyldimethylamine is a solid with a melting point of 23°C that is marketed or used in a non solid or non granular form. Also, the vapour pressure is around 3.96 10-5In addition, 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.

 

Dermal:

No data from repeated dose studies via dermal route. Cocoamidopropyldimethylamine is corrosive to the skin and is not expected to easily pass the skin at non corrosive dose-levels.

 

Absorption, distribution, metabolism, excretion

Data on toxicokinetics for cocoamidopropyldimethylamine is not available. Due to the apolar alkyl chain, and its adherence to negatively charged surfaces, the substance does not easily pass biological membranes at low, non corrosive dose-levels and dermal uptake is therefore very limited. At corrosive dose-levels, the apolar tails easily dissolve in the membranes, whereas the polar head causes disruption and leakage of the membranes leading to cell damage or lysis of the cell content. As a consequence, the whole molecule will not easily pass membrane structures. Cytotoxicity at the local site of contact through disruption of cell membrane will be considered the most prominent mechanism of action for toxic effects. However, due to lack of quantitative data, the absorption rate following oral dosing is considered to be 100%.

 

Dermal absorption

Based on the corrosive properties of cocoamidopropyldimethylamine, dermal absorption as a consequence of facilitated penetration through damaged skin can be anticipated.

Due to the lack of quantitative absorption data, 100% absorption is taken as a conservative approach.