Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6 February 1987 - 25 February 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Performed according to OECD guideline and under GLP. pH was neutralised. No CoA.

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)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts

EC Number:

825-246-3

Cas Number:

2098351-38-1

Molecular formula:

Not applicable UVCB

IUPAC Name:

Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts

Details on test material:

Test material: Ampholak XCE
Appearance: Clear yellow liquid supplied in a screw capped plastic bottle
Date received: 6th of February 1987
Code: 208/8701

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) Limited, Margate, Kent
- Age at study initiation: Young
- Weight at study initiation: Day 1 between 87- 96g
- Fasting period before study: Animals were fasted overnight prior to dosing
- Housing: single sex groups of five in grid bottomed polypropylene cages.
- Diet (e.g. ad libitum): A commercially available pelleted rodent diet (SQC R and M No.1 expanded produced by Special Diet Services, Witham, Essex) ad libitum.
- Water (e.g. ad libitum): mains drinking water via polypropylene bottles were provided ad libitum.
- Acclimation period: 7 days


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


IN-LIFE DATES: 6 February 1987 - 15 days later

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg

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

Doses:

5g/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: All animals were examined frequently after dosing and then daily for fourteen consecutive days. Any signs of toxicity or other effects were noted along with the time of onset and duration. Animals were weighed at weekly intervals.
- Necropsy of survivors performed: yes, at the end of the fourteen day post dose observation period all animals were weighed and then sacrificed by carbon dioxide asphyxiation. Animals were then subjected to gross examination including the opening of the thoracic and visceral cavities.

Statistics:

Not applicable

Results and discussion

Preliminary study:

Not performed

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Remarks:

The maximum dose tested was 5000 mg/kg bw on the technical product, which consists of approximately 40 % active ingredient. The LD50 value is therefore considered to be > 2000 mg a.i./kg bw

Remarks on result:

other: None of the animals died.

Mortality:

No mortalities observed.

Clinical signs:

other: No effects of treatment observed.

Gross pathology:

No abnormalities noted on necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The results of this study indicate that the test material, a technical product has no toxic effect when administered as a single oral dose to the rat at a dose level of 5000mg/kg body weight. The composition of the technical product is 40% active ingredient and 60 % water. Therefore, based on active ingredient, the tested dose level is considered to be 2000mg/kg body weight based on Coco iminodiglycinate, (Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351-38-1). Under the conditions of this study the LD50 > 2000 mg/kg bw. NOTE: PH WAS NEUTRALISED.

Executive summary:

An acute oral limit test was performed under GLP and according to OECD 401. Following overnight fasting a group of five male and five female rats were administered the test material, by peroral injection, at a dose level of 5000 mg/kg bodyweight. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment. No effects of 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 has no toxic effect when administered as a single oral dose to the rat at a dose level of 5000mg/kg bodyweight. Based on the composition of the technical product, the dose level tested is considered to be 2000 mg active ingredient/kg bw based on Coco iminodiglycinate, (Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351-38-1). Under the conditions of this study the LD50 > 2000 mg a.i./kg bw. NOTE: PH WAS NEUTRALISED.