Reaction mass of Amines, coco alkyl and β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs. and β-Alanine, N-coco alkyl derivs.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From August 31, 2001 to December 26, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study (OECD 401)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

The temperature and relative humidity recorded in the animal room were sometimes outside of the target ranges specified in the protocol, and on day 1, food was given back to males 2.5 hours after treatment (instead of 4 hours).

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

see above

Principles of method if other than guideline:

These minor deviations were not considered to have compromised the validity or integrity of the study.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Amines, coco alkyl and ß-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs. and ß-Alanine, N-coco alkyl derivs.

EC Number:

915-790-0

Molecular formula:

n/a

IUPAC Name:

Reaction mass of Amines, coco alkyl and ß-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs. and ß-Alanine, N-coco alkyl derivs.

Test material form:

liquid

Details on test material:

- Purity: 69% (28% isopropanol – 3% water)
- Batch Number: 01652201
- Description: yellow liquid
- Container: one glass flask
- Date of receipt: 28 June 2001
- Storage conditions: at room temperature and protected from light
- Expiry date/stability: June 2002
- Carbon content: 65.8% (weight/weight).

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 Laboratories, L'Arbresle, France
- Age at study initiation: 6 weeks old
- Weight at study initiation: 187 ± 7 g for the males and 149 ± 4 g for the females
- Fasting period before study: yes, the animals were fasted for an overnight period of approximately 18 hours before dosing, but bad free access to water.
- Housing: The animals were housed in polycarbonate cages. Each cage contained one to seven animals of the same sex during the acclimation period and five rats of the same sex during the treatment period.
- Diet (e.g. ad libitum): ad libitum, A04 C pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum, Drinking water filtered by a FG Millipore membrane (0.22 micron)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
-temperature: 21 ± 2°C
-relative humidity: 30 to 70%
-light/dark cycle: 12 h/12 h
-ventilation: approximately 12 cycles/hour of filtered, non-recycled air.


IN-LIFE DATES: From: September 6, 2001 To: September 21, 2001

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

As the test item was anticipated to be non-toxic at 2000 mg/kg, a limit test was performed by administering this dose level to test animals.
The volume of administration was 2.21 mL/kg.
The administration was performed in a single dose by oral route using a metal gavage tube fitted to a 1 mL glass syringe (0.01 mL graduations).
The volume administered to each animal was adjusted according to body weight determined on the day of treatment.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 rats/dose/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations : The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day until day 15.
Type, time of onset and duration of clinical signs were recorded for each animal individually.
- Frequency of weighing: The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes
All study animals were subjected to a macroscopic examination as soon as possible after death. After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. No organ samples were taken.

Statistics:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred at this dose in male and female rats.

Mortality:

No deaths occurred.

Clinical signs:

other: Dyspnea was observed in 1/5 males on days 2 and 3 and in 2/5 females from day 1 up to day 4. No clinical signs were noted in the other animals during the study.

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Other findings:

No

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD0 of the test material is >2000 mg/kg in rats. This is equivalent to an LD0 > 1380 mg/kg for the technical substance.

Executive summary:

The acute oral toxicity of the test item was evaluated in rats according to OECD (No. 401, 24th February 1987) and EC (92/69/EEC, B.1, 31st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

The test item was administered by oral route (gavage) to one group of ten fasted SD rats (five males and five females). The test item was administered undiluted at the dose of 2000 mg/kg, taking into consideration that its specific gravity was 0.908 g/mL. Clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration of the test item. All animals were subjected to necropsy.

No deaths occurred. Dyspnea was observed in 1/5 males on days 2 and 3 and in 2/5 females from day 1 up to day 4. No clinical signs were noted in the other animals during the study. The overall body weight gain of the animals was not affected by treatment with the test item. No apparent abnormalities were observed at necropsy in any animal.

Under these experimental conditions, the oral LD0 of the test item is equal to or higher than 2000 mg/kg in rats. 67/548/EEC, the test item does not present a significant acute toxic risk if swallowed.