Betaines, C12-16 (even numbered) -alkyldimethyl

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 October - 12 November 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

1

Reference substance name:

(carboxylatomethyl)hexadecyldimethylammonium

EC Number:

211-748-4

EC Name:

(carboxylatomethyl)hexadecyldimethylammonium

Cas Number:

693-33-4

Molecular formula:

C20H41NO2

IUPAC Name:

[hexadecyl(dimethyl)ammonio]acetate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Batch No.: UB 4051

Test animals

Species:

rat

Strain:

other: Crl: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles Rive Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg &, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: Not specifically mentioned.
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 169-184 g
- Fasting period before study: 16 hours
- Housing: during the 14 day observation period the animals were kept in groups of 3 in MAKROLON cages (type III plus).
- Diet: commercial diet, ssniff R/M-H V1534 ad libitum. Discontinued 16 h before administration.
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 12-18
- Photoperiod (hrs dark / hrs light): 12/12 (approx 150 lux when lit)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: not stated
- Amount of vehicle (if gavage): not stated
- Justification for choice of vehicle: Test item soluble in water


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw per administration

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 2000 mg/kg bw based on expected low toxicity of the test item.

Doses:

300 or 2000 mg/kg bw, given as two doages of 150 or 1000 mg/kg bw, respectively.
First administration at t = 0 h
Second administration at T = 3 h.

No. of animals per sex per dose:

6 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration, then daily during the 14-d period. Body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study and at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological changes.

Statistics:

Not applicable

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

300 mg/kg bw - no deaths
2000 mg/kg bw - 4/6 animals died

Body weight:

All surviving animals gained the expected wieght at the end of the study period.

Gross pathology:

No pathological changes observed at necropsy

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based on the results of this study, the LD50 is >300 <2000 mg/kg bw.