Gallium

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

As gallium is quite insoluble (ca 46 µg/L) toxicity testing has been performed with gallium(III) nitrate hydrate, which has a higher water solubilty. A read-across approach is followed assuming that the toxicity of gallium (III) nitrate hydrate is completely attributed to the gallium ion. Even if the nitrate ion would contribute partly to the toxicity of the substance, it is considered worst case to completely attribute the toxicity to the gallium ion.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

500 mg/kg bw

Based on:

element

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 of the test item Gallium(III) nitrate hydrate is greater than 300 mg Ga/kg and lower than 2000 mg Ga/kg body weight after single oral administration to Wistar rats.

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Gallium(III) nitrate hydrate is classified in GHS Category 4 with a LD50 cut off value 500 mg Ga/kg body weight, after single oral administration to Wistar rats.

Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test item “Gallium(III) nitrate hydrate” when administered as a single oral dose to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.

A limit dose of 2000 mg Ga/kg body weight was used as a starting dose. Available information indicated that the test item is likely to be non-toxic regarding acute toxicity, therefore, a limit dose of 2000 mg Ga/kg body weight was used as a starting dose. In the first step, one group of 3 females was dosed. The test item in limit dose caused mortality of all animals the first day after administration. In a second step, 3 females were treated with dose of 300 mg Ga/kg body weight. The test item in dose 300 mg Ga/kg did not cause death in the next 48 hours and therefore another 3 females were treated at the same dose level.

The test item Gallium(III) nitrate hydrate administered to 3 females Wistar rats at a limit dose of 2000 mg Ga/kg caused immediate salivation and lethargy. Piloerection and sleep manifested starting ½ an hour after administration and persisted for 4 hours. The first day all three animals died. During necropsy we observed necrosis of the stomach in animal No 1 and 2.

Dose 300 mg/kg of body weight did not cause death in any animal nor evident signs of toxicity in animals No 4 and 5. Animal No 6 manifested immediate piloerection and lethargy. Animals No 7, 8, 9 were lethargic right after test item administration. Salivation occurred in animal No 7 immediately after test item administration. During necropsy, no macroscopic findings were observed.

The LD50 of the test item Gallium(III) nitrate hydrate is greater than 300 mg Ga/kg and lower than 2000 mg Ga/kg body weight after single oral administration to Wistar rats.

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Gallium(III) nitrate hydrate is classified in GHS Category 4 with a LD50 cut off value 500 mg Ga/kg body weight, after single oral administration to Wistar rats.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

500 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

It can be concluded that the test item Gallium(III) nitrate hydrate is classified in GHS Category 4 with a LD50cut off value 500 mg Ga/kg body weight, after single oral administration to Wistar rats.