pentasodium 3,7,11-tris(carboxylatomethyl)-15-(C12-18)-alkyl-3,7,11,15-tetraazaheptadecane-1,17-dioate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 August 1993 - 8 September 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Page 3 with GLP compliance statement is missing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts

EC Number:

307-458-3

EC Name:

Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts

Cas Number:

97659-53-5

Details on test material:

Identity: Ampholak 7CX
Chemical name: Cocoamphopolycarboxyglycinate
Batch number: FP 91327
Expiry: Two years
Purity: Technical; 27% in water
Appearance: Clear liquid
Storage conditions: Room temperature
Date received: 18 August 1993

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: from Harlan Olac Ltd., Bicester, Oxon, England.
- Age at study initiation: 4-7 weeks
- Weight at study initiation: 88-103g
- Fasting period before study: Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
- Housing: housed in groups of up to five rats of the same sex in metal cages with wire mesh floors.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 60
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: 25 August 1993 - 8 September 1993

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 4.34 ml/kg

Doses:

5g/kg

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:
Mortality
Cages of rats were checked at least twice daily for any mortalities.
Bodyweight
The bodyweight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes were calculated.
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical signs
Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of seven hours). On subsequent days animals were observed once in the morning and again at the end of the experimental day. This latter observation was at approximately 16.30 hours on week
days or 11.30 hours on Saturdays, Sundays and public holidays. The nature and severity of the clinical signs and time were recorded at each observation. All animals were observed for 14 days after dosing.

Statistics:

not applicable

Results and discussion

Preliminary study:

Not performed

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: None of the animals died.

Mortality:

There were no deaths following a single oral dose of Ampholak 7CX at 5.0 g/kg bodyweight.

Clinical signs:

other: Piloerection was observed in all rats within five minutes of dosing. This sign persisted and was accompanied at later intervals on Day 1 by abnormal body carriage (hunched posture) and pallor of the extremities. Recovery of all rats, as judged by external

Gross pathology:

No macroscopic abnormalities were observed for animals killed on Day 15.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

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 body weight. The composition of the test material is estimated to be 40% active ingredient (incl NaCl) and 60 % water. Therefore, based on active ingredient, the tested dose level is considered to be 2000mg/kg body weight based on Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts (CAS no 2060541-51-5). Under the conditions of this study the LD50 > 2000 mg/kg bw.

Executive summary:

A study was performed to assess the acute oral toxicity of the test material to the rat. The method followed was that described in EEC Methods for the determination of toxicity, Annex to Directive 92169lEEC (OJ No. L383A, 29.12.92), Part B, Method B. 1. Acute toxicity (oral). A group of ten fasted rats (five males and five females) was given a single dose by gavage of the test substance, as supplied, at a dose level of 5.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period.

There were no deaths. Clinical signs of reaction to treatment consisted of piloerection, abnormal body carriage and pallor of the extremities, recovery was complete by Day 2. All rats achieved anticipated bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15. Based on the active ingredient of the test material, the LD50 > 2000 mg a.i./kg bw for the Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts (CAS no 2060541-51-5).