Gadoliniumsulfite trihydrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7 June 2002 - 8 July 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Gadoliniumsulfite trihydrate

EC Number:

456-900-2

EC Name:

Gadoliniumsulfite trihydrate

Cas Number:

51285-81-5

Molecular formula:

Gd2(SO3)3*3H2O

IUPAC Name:

digadolinium(3+) trihydrate trisulfite

Test material form:

solid: particulate/powder

Details on test material:

Off white, crystalline powder
Batch number FSG 3896 or 02-FW-095

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

The rats were housed in an air-conditioned room of about 25m2 in the Institute of Toxicology. Lighting was controlled by a timer to provide a 12 hour light - 12 hour dark regime.
The rats were kept separately in type III Makrolon cages with a shelter, placed on mobile racks. Conventional softwood granulate was used as the bedding. One day bedore treatment, and up to 24 hours after dosing, metal grids were placed above the softwood granulate. The cages and the metal grid had been machine-cleaned before the start of the experimental part. The bedding was changed two times per week.
Tempearture and humidity were measured using a thermohygrograph. The room temperature during the experimental period was 21 to 25 °C and the relative atmospheric humidity 51 to 83 %. The temperature and the relative atmospheric humidity in the animal room was transiently outside the target range of 20 to 24 °C and 45 to 75 %. This minor and short deviation did not influence the integrity of the study.
Diet was withheld from about 17 hours before until up to 4 hours after treatment. At all other times food and community tap water from Makrolon drinking bottles were available to the rats ad libitum.
The diet (Art. 3433 for mice and rats, Provimi Kliba AG) was checked according to the specifications of the manufacturer. Analysis included both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics.
The drinking water was periodically analyzed according to the German regulations for human drinking water.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Methocel K4M Premium

Doses:

2000 mg / kg bw

No. of animals per sex per dose:

3

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All rats survived the abservation period.

Clinical signs:

other: No signs of toxicity were detected in the rats (3 males and 3 females) after treatment with 2000 mg/kg.

Gross pathology:

The gross pathological examination revealed no organ alterations.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result of this study, it is considered that Gadoliniumsulfite trihydrate has no toxic potential and that the LD50 value is higher than 2000 mg/kg afteroral treatment in rats.

Executive summary:

Gadoliniumsulfite trihydrate was tested for acute toxicity in rats after oral administration of 2000 mg/kg body weight. Directly before administration the test material was prepared with aqueous Methocel® K4M Premium solution as the vehicle. This study was performed according to the "Acute toxic class method" (ATC). No signs oftoxicity were detected in the rats (3 males and 3 females) after treatment with 2000 mg/kg. There were no deaths during the course ofthe study. The gross pathological examination revealed no organ alterations. Based on the result of this study, it is considered that Gadoliniumsulfite trihydrate has no toxic potential and that the LD50 value is higher than 2000 mg/kg after oral treatment in rats.