Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No data on batch no and composition is included in the study report. Internal data on composition is available. Study according to guideline/standards.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate

EC Number:

305-318-6

EC Name:

Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate

Cas Number:

94441-92-6

Molecular formula:

C14H26NO4.Na

IUPAC Name:

sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate

Details on test material:

Appearance: clear orange liquid
Date of receipt: 29 January 1987

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: no info except for young adult
- Weight at study initiation: 91 ± 6 g (males), 90 ± 3 g (females)
- Fasting period before study: overnight prior to dosing
- Housing: five per sex in polypropylene cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 49-61
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 6 To: 20 February 1987

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: not indicated
- Amount of vehicle (if gavage): 20 mL/kg
- Justification for choice of vehicle: no info

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

DOSAGE PREPARATION (if unusual): the test material was neutralised to a pH of 7.0 using 1.0 M citric acid and then diluted with
distilled water to give a dose volume of 20 mL/kg at a dose level of 5000 mg/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:frequently after dosing and then daily; BW weekly
- Necropsy of survivors performed: yes
- Other examinations performed: no

Statistics:

Not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: no mortality

Mortality:

None

Clinical signs:

other: One female and five male animals exhibited piloerection within one hour of dosing, one male animal also exhibiting perinasal staining.The animals had fully recovered by Day 2 (Day 1 is day of dosing).

Gross pathology:

No abnormalities noted

Other findings:

No

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The test material used consists of 40% active ingredient and 60% water. As the oral LD50 of the product is > 5000 mg/kg bw, the LD50 of the active ingredient is considered to be > 2000 mg/kg bw. Therefore the active ingredient is classified as Category V, according to OECD-GHS criteria.

Executive summary:

The toxicity of the test material was assessed following its oral administration to a group of five male and five female rats. The procedure used meets the requirements of the limit test for acute oral toxicity described by the OECD (Organisation for Economic Co-operation and Development). Following overnight fasting rats were administered the test material, by peroral injection, at a dose level of 5000 mg/kg bw. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment. One female and five male animals exhibited piloerection within one hour of dosing, one male animal also exhibiting perinasal staining. The animals had fully recovered by Day 2 (Day 1 is day of dosing). No other effects to treatment were observed throughout the duration of the study and no abnormalities were detected at necropsy. The results of this study indicate that the test material, Ampholak YJH, has little toxic effect when administered as a single oral dose to the rat at a dose level of 5000 mg/kg bw. The test material used consists of 40% active ingredient and 60% water. As the oral LD50 of the product is > 5000 mg/kg bw, the LD50 of the active ingredient is considered to be > 2000 mg/kg bw. Therefore it is classified as Category V, according to OECD-GHS criteria.