Imidazolium compounds, 1-[2-(2-carboxyethoxy)ethyl]-1(or 3)-(2-carboxyethyl)-4,5-dihydro-2-norcoco alkyl

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no specified (1978)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Observation period of 5 days instead of 14 days. Body weight measurement and necropsy not reported.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

1

Reference substance name:

Imidazolium compounds, 1-[2-(2-carboxyethoxy)ethyl]-1(or 3)-(2-carboxyethyl)-4,5-dihydro-2-norcoco alkyl

EC Number:

272-897-9

EC Name:

Imidazolium compounds, 1-[2-(2-carboxyethoxy)ethyl]-1(or 3)-(2-carboxyethyl)-4,5-dihydro-2-norcoco alkyl

Cas Number:

68919-40-4

Molecular formula:

R_C8 H14 N2 O4 Na With R=Cn H2n+1 n=8, 10, 12, 14, 16, 18

IUPAC Name:

disodium 3-({2-[N-(2-hydroxyethyl)hexadecanamido]ethyl}amino)propanoate 3-[(2-hexadecanamidoethyl)(2-hydroxyethyl)amino]propanoate

Test material form:

solid - liquid: aqueous solution

Details on test material:

- Batch No.: 4324D78

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: 4324D78
- Expiration date of the lot/batch: not specified
- Purity test date: not specified

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
- Age at study initiation: not specified
- Weight at study initiation: 18 to 21g
- Fasting period before study: not specified
- Housing: in wire cages, 5 animals/cage
- Diet (e.g. ad libitum): Lab blox ad libitum
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified

IN-LIFE DATES: not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: not specified
- Amount of vehicle (if gavage): not specified
- Justification for choice of vehicle:not specified
- Lot/batch no. (if required): not specified
- Purity: not specified

MAXIMUM DOSE VOLUME APPLIED: not specified

Doses:

8330, 10000, 11600 mg/kg bw

No. of animals per sex per dose:

10 animals/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 5 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: no
- Other examinations performed: not specified

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

9 800 mg/kg bw

Based on:

not specified

Mortality:

Dose group 8330 mg/kg bw: 2/10
Dose group 10000 mg/kg bw: 5/10
Dose group 11600 mg/kg bw: 8/10

Clinical signs:

other: no specified

Gross pathology:

not assessed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on a LD50 in mice of 9800 mg/kg bw, the registered substance is not classified for acute oral toxicity according to CLP and GHS UN criteria.

Executive summary:

The registered substance has been tested for acute oral toxicity in CF-1 mice (product name = Miranol C2M AA). The test article was administered after a 1:2 dilution in water in a single oral dose to three groups of 10 mice at a dose volume of 8.33, 10.0 and 11 g/kg, respectively. Examinations for mortality and clinical signs were performed daily during a 5-day observation period.

 

A mortality of 20% was observed in the group receiving the lowest dose, 50% in the group treated at 10 g/kg, and 80% in the group receiving 11 g/kg. The acute oral toxicity was calculated to be 9.8 g/kg (with 95% confidence limits of 8.9-10.8 g/kg) i.e. 9800 mg/kg bw.

 

As the acute oral LD50 is higher than 5000 mg/kg b.w., the registered substance is not classified according to CLP and GHS UN criteria.