Magnesium, EDTA cobalt copper iron manganese zinc complexes

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:

other: This study was conducted in accordance with the following Good Laboratory Practice Standards with the exception that analysis of the testmaterial mixture for concentration, homogeneity/solubility, and stability was not conducted.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

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:

Magnesium, EDTA cobalt copper iron manganese zinc complexes

EC Number:

607-234-8

Cas Number:

234446-82-3

Molecular formula:

Unspecified (UVCB substance)

IUPAC Name:

Magnesium, EDTA cobalt copper iron manganese zinc complexes

Constituent 2

Reference substance name:

TKA 45028

IUPAC Name:

TKA 45028

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): TKA 45028
- Physical state: light-green powder
- Composition of test material, percentage of components:
CAS 234446-82-3 is the main component of the product TI name, which is a preparation of approx. 2.5 % disodiumoctaborate , 0.25 % sodiummolybdate and CAS 2344446-82-2. The product also contains approximately 10 % water as residual humidity. The content of CAS 2344446-82-2 in the product is therefore approximately 87 %.

- Purity test date: The Sponsor assumes responsibility for purity and stability determinations
- Lot/batch No.: ELW1099
- Stability under test conditions: The Sponsor assumes responsibility for purity and stability determinations (including under test conditions).
- Storage condition of test material: The test material was stored at room temperature.

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: rats were procured from Charles River Laboratories, Portage, Michigan, on December 13, 1999.
- Age at study initiation: approximately 7 to I I weeks of age
- Weight at study initiation: weighing from 203 to 229 g
- Fasting period before study: for 17 to 20 hours before test material administration
- Housing: After receipt, the animals were acclimated for a period of at least 5 days. During acclimation and throughout the study, the animals were separated by sex and group housed in suspended, stainless steel cages.
- Diet (e.g. ad libitum): continuous access to rodent diet (#8604, Harlan Teklad)
- Water (e.g. ad libitum):continuous access to water
- Acclimation period: After receipt, the animals were acclimated for a period of at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): I 8 to 26°C
- Humidity (%): 30 to 70%,
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: The test material was mixed with distilled water to a concentration of 0.4 mg/ml
- Amount of vehicle (if gavage): 5 ml/kg of body weight
- Justification for choice of vehicle: common vehicle


MAXIMUM DOSE VOLUME APPLIED:

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: Clinical observations were conducted at 1, 2.5, and 4 hours after test material administration and daily thereafter for 14 days.

- Frequency of observations and weighing:
Body weights were determined before test material administration (Day 0), at Day 7, and at termination of the in-life phase (Day 14).

- Necropsy of survivors performed: yes

Statistics:

No statistical evaluations were required by the protocol.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: content of TI in product: 87%

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 740 mg/kg bw

Based on:

act. ingr.

Mortality:

No mortality was observed during the study

Clinical signs:

other: All an imals appeared normal throughout the study

Gross pathology:

There were no visible lesions observed at the macroscopic necropsy examinations conducted at termination.

Applicant's summary and conclusion

Conclusions:

No mortality was observed during the study and therefore the estimated oral LD50 values for male and female rats were determined to be greater than 2,000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test substance was evaluated in male and female rats when administered as a single gavage dose at a Ievel of 2000 mg/kg of body weight. No mortality was observed during the study. The estimated oral LDso values for male and female rats were determined to be greater than 2000 mg/kg. All animals appeared normal and exhibited body weight gain throughout the study. The macroscopic necropsy examinations conducted at termination did not reveal any visible lesions. Based on the results of this study, the acute oral toxicity caused by test substance was insufficient for a risk phrase to be necessary under terms of the General Classification and Labeling Requirements for Dangerous Substances and Preparations, as stated in Annex IV to Commission Directive 93121/EC. The test material is not considered to be a toxic material.