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Administrative data

Description of key information

From the surrogate data available, this substance does not appear to exhibit acute toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

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
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
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.
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
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).
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
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.

Endpoint:
acute toxicity: oral
Data waiving:
study waived due to provisions of other regulation
Justification for data waiving:
other:
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Single dose, 14 day observation
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
EPA review of data
Study performed on non-phosphated form
Results used to help confirm biological equivalence for read across
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
other: Old LD50 protocol
Limit test:
no
Specific details on test material used for the study:
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.
This is considered to be a good surrogate substance for the substance being registered.
Further animal testing cannot be justifed.
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
water
Doses:
Dose levels based on actives; 1200 mg/kg - 10 000 mg/kg
No. of animals per sex per dose:
Five
Control animals:
not specified
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 500 mg/kg bw
Based on:
act. ingr.

Mortality reported at highest concentrations

No pathology reported

Interpretation of results:
GHS criteria not met
Conclusions:
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.
Cocamidopropyl betaine is considered to be a good surrogate substance for the substance being registered.
Further animal testing cannot be justifed.
(Note - HPV reports indicate other acute toxicity tests and although some variation in results, it is concluded that the substance need not be classified as harmful)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 hours on occluded skin
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Remarks:
No details given in the review report.
Test type:
standard acute method
Specific details on test material used for the study:
94.9% pure
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Groups of 5 male Sprague-Dawley rats received the test material dermally on clipped trunks; test sites were occluded for 24 h, after which the test sites were wiped clean of the test material
Duration of exposure:
24 hours
Doses:
not specified
No. of animals per sex per dose:
5
Control animals:
not specified
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 16 other: g/kg
Based on:
test mat.
Clinical signs:
other: Erythema, edema, desquamation, necrosis, and scab formation observed on test sites for test material, as was sluggishness and reddish nasal and ocular discharges; body weight gains within normal parameters; no treatment-related changes due to either test
Interpretation of results:
GHS criteria not met
Conclusions:
Cetyl betaine is not harmful by skin absorption.
Lauryl betaine has a very similar structure to cetyl betaine, the only difference being in the chain length of the alkyl grouping, i.e. C16 9cetyl) vs C12 (lauryl).
The CIR 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'
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
24 hours exposure; 14 day observation
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
US EPA source considered reliable
Test performed on analogue substance; 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 between this test material and cetyl betaine.
Although headline result is LD50 > 2 g/kg, it is uncertain if this relates to the active or to a diluted test material.
However, the EPA have judged the result as 'valid without restrictions' and cited 2 g/kg.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Limit test
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Source not specified. Activitiy not specified (not known if test material was a diluted form)
Species:
rat
Strain:
CD-1
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg (assumed actives)
No. of animals per sex per dose:
Five
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No
Clinical signs:
other: Local irritation
Gross pathology:
No adverse effects on termination
Interpretation of results:
GHS criteria not met
Conclusions:
Local irritation, but this resolved during the observation periods
Although headline result is LD50 > 2 g/kg, it is uncertain if this relates to the active or to a diluted test material.
However, the EPA have judged the result as 'valid without restrictions' and cited 2 g/kg.
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Specific details on test material used for the study:
30 – 35.5 % aqueous solution.
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 between this test material and cetyl betaine.
Species:
rat
Strain:
not specified
Sex:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
study cannot be used for classification
Conclusions:
The acute toxicity of cocamidopropyl betaine (30 – 35.5 % aqueous solutions) in rats is low, with a dermal LD50 value greater than 2000 mg/kg bw.
The active ingredient level is ca. 600 mg/kg/bw but since the test does not appear to have been taken to a higher level of active ingredient, this value cannot be used for classification.
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

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.

Justification for classification or non-classification