Violet sodium polysulfide aluminosilicate with a SOD-type framework structure

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Remarks:

acute toxic class method

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 16th June 2004 to 30th June 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

OECD guideline 423. GLP study.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium polysulfide aluminosilicate with a SOD-type framework structure

EC Number:

701-340-9

Molecular formula:

|Na+6-x+y+z (S2•-)y(S3•-)z|[Al6-x Si6+x O24] - SOD Where: 6 ≤ 6-x+y+z ≤ 8 0 ≤ x ≤ 1.2 1 ≤ y+z ≤ 2

IUPAC Name:

Sodium polysulfide aluminosilicate with a SOD-type framework structure

Test material form:

solid: particulate/powder

Details on test material:

- Physical state: a blue powder

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Age at study initiation: 7 weeks- Weight at study initiation: 183-190 g- Housing: stainless-steel cages- Water (e.g. ad libitum): free bottle of water intake tap water- Acclimation period: 2 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 23ºC- Humidity (%): 55%

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

1% sodium carboxymethylcellulose solution

Doses:

2000 mg/kg

No. of animals per sex per dose:

2 groups of 3 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days - Frequency of observations and weighing: 1time/day- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

other: No clinical signs

Gross pathology:

No autopsy findings for pathological damage.

Other findings:

Bluish feces in the 3 female rats of a group at 1st day after administration derived from the color of the test material.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified.

Remarks:

Criteria used for interpretation of results: EU. According to GHS criteria the test item could be classified in the Category 5 or as " GHS criteria not met", further information is needed regarding acute oral toxicity taking 5000mg/kg bw

Conclusions:

The result was as follows: LD50 >2000 mg/kg bw

Executive summary:

The aim of the test was to study the single dose oral toxicity of the test material according to OECD Test Guideline 423.

The test material was studied in 6 female rats (2 groups with 3 female rats per group) in a single dose oral toxicity test at 2000 mg/kg bw. On observation for general signs, only bluish feces, derived from the color of the test material, were noted. The result was as follows: LD50 >2000 mg/kg bw