Gadoliniumsulfite trihydrate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 March 2003 - 19 May 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

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 25 m2 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 Ill Makroion cages with a shelter, placed on mobile racks. Conventional softwood granulate was used as the bedding. One day before treatment, and up to 24 hours after dosing, metal grids were placed above the softwood granulate. The cages and the metal grids had been machine-cleaned before the start of the experimental part. The bedding was changed two times per week. Temperature and humidity were measured using a thermohygrograph. The room temperature during the experimental period was 22 to 23 °C and the relative atmospheric humidity 40 to 66 %. The relative atmospheric humidity in the animal room was transiently outside the target range of 45 to 75 %. This minor and short deviation did not influence the integrity ofthe study. Diet and community tap water from Makroion drinking bottles were available to the rats ad libitum. The diet, Provimi Kliba 3433.0, 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

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

The backs and abdomens of the rats were shaved with an electric hair clipper approximately one hour before treatment. The test material was prepared, spread on the shaven skin in an area of 6 x 6 cm, and covered with a gauze patch. This was kept in place by a self-adhesive fabric (Fixomull® stretch, Beiersdorf). The time of exposure was 24 hours. Then the gauze and adhesive fabric were removed and any remaining testmaterial was wiped off carefully.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

On the day of treatment general condition and motility of the rats were slight affected by the tape. lt was difficult to distinguish between slight clinical findings and reactions due to fixation by the tape. The behavior and general condition of all rats were monitored for at least 6 hours after administration and then checked daily. All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
All rats were sacrificed at the end of the experimental part by C02-asphyxia and subjected to a gross pathological investigation.

Statistics:

The body weight development of each rat and group was determined. The group mean value was calculated for each measurement and printed on tables.

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:

All rats survived the observation period.

Clinical signs:

other: No signs of toxicity were detected in the 5 male and 5 female rats after dermal treatment with 2000 mg/kg.

Gross pathology:

At necropsy, no organ alterations were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result of this study, Gadoliniumsulfite-trihydrat can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg after dermal application to rats.

Executive summary:

Gadoliniumsulfite-trihydrat was tested for acute toxicity in rats after dermal administration of 2000 mg/kg body weight. Directly before administration the test material was prepared with Aqua pro injectione as the vehicle, spread on the shaven skin in an area of 6 x 6 cm, and covered with a gauze patch. This was kept in place by a self-adhesive fabric (Fixomull® stretch, Beiersdorf). The time of exposure was 24 hours. Then the gauze and adhesive fabric were removed and any remaining testmaterial was wiped off carefully. No signs oftoxicity were detected in the rats (5 males and 5 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, Art. 170210 can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg after dermal application to rats.