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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated 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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
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:
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 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 levelsopen allclose all
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:
not reported
Body weight:
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.

Applicant's summary and conclusion