(carboxylatomethyl)dodecyldimethylammonium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Only very limited documentation, only 5 days observation period

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

EC Number:

263-058-8

EC Name:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

Cas Number:

61789-40-0

Molecular formula:

C19H38N2O3

IUPAC Name:

{[3-(Dodecanoylamino)propyl](dimethyl)ammonio}acetate

Test material form:

liquid

Specific details on test material used for the study:

Physical state: liquid, aqueous solution
- Analytical purity: 30% a.i.
- Composition of test material, percentage of components: 30 % active (C8-18 with majority in C12-14), 7 % sodium chloride, 63 % water
- Lot/batch No.: 26R-259.
The members of the alkyl betaines category are amphoteric surfactants containing a quaternary 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.
The Cosmetic Ingredient Review Expert Panel reviewed the product use, formulation and safety data of eleven alkyl betaines, as used in cosmetics. (Final report issued 2014-04-04)
The Panel concluded that the common core chemical structure, similar functions and concentrations in cosmetics, and the predicted physicochemical properties enabled grouping these ingredients and reading across the available toxicological data to support the safety assessment of each individual compound in the entire group.

Test animals

Species:

mouse

Strain:

CF-1

Sex:

not specified

Details on test animals or test system and environmental conditions:

- Source: Charles River
- Weight at study initiation: 18 - 21 g
- Fasting period before study: no data
- Housing: 5/cage
- Diet (e.g. ad libitum): Lab Blox, ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

- Concentration in vehicle: 10 % (test material was diluted 1:3 in water just prior to the test)

Doses:

6670, 8350, 10000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 5 days
- Necropsy of survivors performed: no data

Statistics:

Oral LD50 was calculated according to the method of Litchfield and Wilcoxon (1949).

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

2 640 mg/kg bw

Based on:

act. ingr.

95% CL:

>= 2 310 - <= 3 000

Remarks on result:

other: recalculated to neat substance

Mortality:

10000 mg/kg: 7/10
8350 mg/kg: 4/10
6670 mg/kg: 1/10

Clinical signs:

other: not reported

Gross pathology:

not reported

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Cocoalkyldimethylbetaine has a similar structure to lauryl betaine.This is considered to be a good surrogate substance for the lauryl betaine being registered.
Further animal testing cannot be justified.

Executive summary:

The members of the alkyl betaines category are amphoteric surfactants containing a quaternary ammonium ion and a carboxylic structure.

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. The Cosmetic Ingredient Review Expert Panel reviewed the product use, formulation and safety data of eleven alkyl betaines, as used in cosmetics. (Final report issued 2014-04-04). The Panel concluded that the common core chemical structure, similar functions and concentrations in cosmetics, and the predicted physicochemical properties enabled grouping these ingredients and reading across the available toxicological data to support the safety assessment of each individual compound in the entire group.