Magnesium, EDTA cobalt copper iron manganese zinc complexes

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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 OECD Principles of Good Laboratory Practice.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

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

Test material form:

other: green solid

Details on test material:

- Name of test material (as cited in study report): Magnesium, EDTA cobalt copper iron manganese zinc complexes
- Physical state: solid
- Analytical purity: 90%
- Composition of test material, percentage of components: CAS 234446-82-3 is the main component of the product, 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.
- Lot/batch No.: 0005823397
- Storage condition of test material: Room temperature, protect against humidity under light exclusion

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories B.V., Kreuzelweg 53, 5961 NM Horst, NIEDERLANDE
- Age at study initiation: about 8 – 11 weeks
- Weight at study initiation: male: 266g and female: 204g
- Housing: Makrolon cages, type M III
- Diet (e.g. ad libitum): ad libitum, Kliba-Labordiät
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: 5 days before exposure

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%): 30 – 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Dosing wheel dust generator (Gericke/BASF)
- Exposure chamber volume: ca. 34L
- Method of holding animals in test chamber: the animals were restrained in glass tubes and their snouts projected into the inhalation system
- Method of conditioning air: The central air conditioning system provides cold air of about 15°C. This cold air will passes through an activated charcoal filter, is adjusted to room temperature of 20 to 24°C and passes through a second particle filter (H13 (HEPA) Camfil Farr, Germany). The so generated conditioned air was used to generate inhalation atmospheres.
- Treatment of exhaust air: The exhaust air was filtered and conducted into the exhaust air of the building
- Particle size analysis: The collecting discs and the backup particle filter were re-weighed after samöling the impactor and the amounts of material adsorbed to the walls of the impactor and in the sampling probe (wall losses) were determined quantitative.


TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric measurement
- Samples taken from breathing zone: yes


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: The calculation of the particle size distribution was carried out in the inhalation laboratory on the basis of mathematical methods for evaluating particle measurements.
- MMAD (Mass median aerodynamic diameter): between 3.2 and 3.6 µm

CLASS METHOD (if applicable)
The selection of the concentration for test group 1 was based on available information about the toxicity of related test substances. The selection of the concentration for test group 2 was based on the limit test

Duration of exposure:

4 h

Concentrations:

The following measured concentrations were tested: 2.413 and 5.107 mg/L (analytical concentration). Nominal concentration 50.3 and 121.3 mg/L.

No. of animals per sex per dose:

Five male and five female rats were used for each test group.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Shortly before exposure (day 0) and on days 1, 3 and 7, and before the sacrifice of the animals at the end of the observation period (day 14).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights

Statistics:

Binomial test was used for statistical evaluation

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.1 mg/L air

Based on:

act. ingr.

Exp. duration:

4 h

Mortality:

No mortality occurred at the tested concentrations.

Clinical signs:

other: Clinical signs of toxicity in animals exposed to 2.413 mg/L comprised piloerection and substance-contaminated fur. These various findings were observed from study day 0 after exposure through to study day 2. No clinical signs and findings were observed fr

Body weight:

Test group 1 (2.413 mg/L)
The mean body weights of the male animals decreased during the first post exposure observation day and increased from study day 3 onward. The mean body weights of the female animals decreased during the first few post exposure observations days and increased from study day 7 onward.

Test group 2 (5.107 mg/L)
The mean body weights of the animals decreased during the first post exposure observation day and increased from study day 3 onward.

Gross pathology:

No gross pathological abnormalities were detected during the necropsy in the animals at the termination of the study.

Other findings:

Cascade impactor measurements resulted in particle size distributions with mass median aerodynamic diameters (MMADs) between 3.2 and 3.6 µm, which are at the upper end of the respirable range . In spite of several technical measures (mixing, addition of 2% AEROSIL® R 972, an anti-hygroscopic agent, to improve the flow ability) no smaller particle size could be reached. Hence, the above mentioned MMAD can be described as the smallest technically achievable particle size.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the current study condition, LC50 value was > 5.1 mg/L in male and female Wistar rats after 4 hour inhalation exposure to dust of Magnesium, EDTA cobalt copper iron manganese zinc complexes.

Executive summary:

To determine the acute inhalation toxicity (single 4-hour exposure, nose only) of Magnesium, EDTA cobalt copper iron manganese zinc complexes as a dust, a study was performed in male and female Wistar rats according to OECD-Guideline method 403. The following measured concentrations were tested: 2.413 and 5.107 mg/L (analytical concentration). Nominal concentration 50.3 and 121.3 mg/L.

No mortality occurred at the tested concentrations and at the end of the post exposure observation period no clinical signs of toxicity or abnormalities were noted.

Under the current study condition, LC50 value was > 5.1 mg/L in male and female Wistar rats after 4 hour inhalation exposure to dust of Magnesium, EDTA cobalt copper iron manganese zinc complexes and therefore does not needs to be classified. (BASF, 2014)