Betaines, C12-14 (even numbered)-alkyldimethyl

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:

other: Study meets generally accepted scientific principles, acceptable for assessment. Only very limited documentation, only 5 days observation period.

Justification for type of information:

This study for the source substance Coco Betaine which is used as read-across to the registered (target) substance. See section 13 for the full read-across justification.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study meets generally accepted scientific principles, acceptable for assessment. Only very limited documentation, only 5 days observation period.

Justification for type of information:

This study for the source substance Coco Betaine which is used as read-across to the registered (target) substance. See section 13 for the full read-across justification.

Reason / purpose for cross-reference:

read-across source

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

Species:

mouse

Strain:

CF-1

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- 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:

water

Details on oral exposure:

VEHICLE
- 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 (sex not specified)

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

Sex:

not specified

Dose descriptor:

LD50

Effect level:

8 800 mg/kg bw

Based on:

test mat.

95% CL:

7 700 - 10 000

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

According to the criteria of EU Directive 67/548/EEC and the criteria of Regulation (EC) No 1272/2008 the test substance does not have to be classified for acute oral toxicity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

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:

68424-94-2

Cas Number:

68424-94-2

IUPAC Name:

68424-94-2

Test material form:

other: aqueous formulation

Details on test material:

- Name of test material (as cited in study report): cocoalkyldimethylbetaine
- Substance type: surfactant
- 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

Test animals

Species:

mouse

Strain:

CF-1

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- 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:

water

Details on oral exposure:

VEHICLE
- 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 (sex not specified)

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

Effect levels 1

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

Effect levels 2

Sex:

not specified

Dose descriptor:

LD50

Effect level:

8 800 mg/kg bw

Based on:

test mat.

95% CL:

7 700 - 10 000

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

Any other information on results incl. tables

According to the criteria of EU Directive 67/548/EEC and the criteria of Regulation (EC) No 1272/2008 the test substance does not have to be classified for acute oral toxicity.