Alanine, N,N-bis(carboxymethyl)-, sodium salt (1:3)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Reference 2

Reference Type:

other: amendment

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3043/V9Z
- physical state at ambient conditions: solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Animal species: rat / wistar / chbb: thom (SPF)
- Animal breeder: Dr. K. Thomae GmbH, Biberach, Germany
- Age of the animals: young adult animals.
- Animal weights at start of the study: animals of comparable weight; (150g - 300g) (+/- 20 % of the mean weight).
- Animal identification: individual identification using cage cards and group identification by tail marking.
- Room temperature/Relative humidity: the animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24 degrees Celsius for temperature and of 30.- 70 % for relative humidity. There were no deviations from these ranges which influenced the results of the study.
- Day/night rhythm: 12 h/12 h (6.00 a.m. - 6.00 p.m./ 6.00 p.m. - 6.00 a.m.)
- Type of cage: stainless steel wire mesh gages, type DK-III (Becker & Co., Castrop-Rauxel, Germany)
- No. of animals per cage: single housing.
- Bedding: no bedding in the gages; sawdust in the waste trays.
- Drinking water: tap water ad libitum per day.
- Diet: Kliba-Labordiaet 343, Klingentalmuehle AG Kaiseraugst, Switzerland, ad libitum.

Analysis of drinking water:
The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of BASF AG as well as for the presence of germs by a contract laboratory.

Analysis of feed:
The feed used in the study was assayed for chemical and microbiological contaminants.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

FASTING OF ANIMALS:
-16 h before administration of test substance, water available ad libitum

VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: aqueous formulation corresponds to physiological medium.
- Stability of test substance: Test substance stable in drinking water for at least 4 days

CLASS METHOD
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance, no pronounced acute oral toxicity was expected. Therefore a dose of 2000 mg/kg bw was selected as starting dose.

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were recorded several times at the day of administration and at least once daily thereafter. Animals were weighed at day 0 before administration and once weekly thereafter.
- Necropsy of survivors performed: yes, fasting of animals 16 h before sacrifice
- Other examinations performed: clinical signs, body weight

Statistics:

none

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Female animals: 3 animals displayed impaired general state, dyspnoe, staggering and piloerection. All symptoms were reversible until 3 days post application. Male animals: no abnormalities.

Gross pathology:

No abnormalities noted at necropsy of animals sacrificed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met