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Toxicological information

Acute Toxicity: oral

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
not reported
Body weight:
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 cetyl betaine.This is considered to be a good surrogate substance for the cetyl 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.