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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Published data for the actual substances' toxcity to daphnia magna and algae show values in the 1 - 10 mg/l range.

EC50 48 hour values for daphnia are reported in the range of 2.0 - 5.3 mg/l

EC50 72 hour growth rate values for algae are reported in the range 2.5 - 11 mg/l

Evidence shows that fish are more tolerant to the class of substance than algae and further animal testing is not justified

Acute toxicity is predicted to be in the range of 1 - 10 mg/l. The value chosen here is the lowest value from the published data on various fish species.

Data for a similar substance as detailed below would support the results taken from a variety of publications on this substance.

Overall, the toxicity to algae and Daphnia are similar with the Daphnia perhaps being marginally more sensitive, and it is the Daphnia end point data, which is considered as reliable, that will be used to decide on the classification. 


Additional information

The members of the alkyl betaines category are amphoteric surfactants containing a quarternary ammonium ion and a carboxylic structure. They are referred to as inner salts due to their zwitterionic character. They are all manufactured from natural materials such as vegetable oils and can vary in chain length from C8 to C18. They are generally marketed as aqueous solutions (20 - 40 %).

Because of the structural and functional similarities and comparable physico-chemical properties these inner salts and sodium salts, a similar ecotoxicological and toxicological profile can be expected.

OECD SIDS data exists for a similar group of betaines, this time with an extra amide bond. These are known as alkylamidopropyl betaines. They also have alkyl chain lengths in the same range as the straight alkyl betaines.

Both types of betaine are used extensively in the cosmetics and personal care products as surfactants and selection of the type used is generally based on the end skin feel, foaming nature and viscosity. They are comparative in their expected toxicology.

Data in the SIDS assessment profile (SIAM 23 - Oct 2006) suggests similar values to those quoted in the end point data here.

The following text has been taken from this document;

For the acute toxicity of cocamidopropyl betaine to aquatic species reliable results from tests with fish, daphnia,

algae, and microorganisms are available. The lowest acute LC/EC50 values for the three trophic levels fish,

Daphnia, and algae are in each case in the range of 1.3 – 2 mg active substance/l. Furthermore, one long-term test

with fish (according to OECD TG 215), and several chronic tests with Daphnia and algae were conducted. The

lowest NOECs are 0.16 mg active substance/l for fish (Oncorhynchus mykiss), 0.03 mg active substance/l for

Daphnia magna, and 0.09 mg active substance/l for green algae (Desmodesmus subspicatus). These values were

derived with analytical monitoring (photometric) except for the algae test. However, the effect values within the

same species (e.g., Desmodesmus subspicatus, Daphnia magna) have shown a high variability. Recent guideline

studies performed in accordance with OECD TG 211 and 201 using state-of-the-art analytical monitoring and a

quality of cocamidopropyl betaine currently commercialized, resulted in a lower aquatic toxicity. In these studies

the lowest NOEC for daphnids was determined to be 0.932 mg active substance/l. the lowest NOEC (72 h, based

on growth rate) for algae was determined to be 3.55 mg active substance/l (72 h-ErC50= 9.86 mg active

substance/l). This latter NOEC for algae is further supported by the similar NOEC of 3.53 mg active substance/l

calculated using the geometric mean of all valid tests with this algae species. Furthermore, for algae a potential

for recovery from the effect up to a concentration of 96 mg active substance/l has been observed