Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

A chemical safety assessment and chemical safety report according to Art. 14 REACH is not required for the registration of a substance in tonnage band 1-10 tonnes. Therefore no DNELs have been derived for this substance.

Acute Toxicity

The variations L181 and L175G25C4G were tested for acute oral toxicity in a GLP guideline studies according to OECD 423.

The variation L175G225C4G was tested for acute toxicity via the inhalation route in a GLP guideline study according to OECD 403.

The variation L181 was tested for acute dermal toxicity in a GLP guideline study according to OECD 402.

Both variations did not exhibit any acute toxicity via any route of exposure.

The studies for the inhalation route and the dermal route are not required under REACH for the tonnage band 1 - 10 t/a. The results of the 4 studies on acute toxicity reveal the same toxicological profile for both variations. The same toxicological profile is expected for other variations of the substance pentaaluminium triyttrium dodecaoxide.

Irritation / Corrosion

The variation L181 was tested for the potential to cause skin irritation in a GLP guideline studies according to OECD 404.

The substance did not exhibit skin irritation or skin corrosion.

The same profile is expected for other variations of the substance pentaaluminium triyttrium dodecaoxide.

The variations L181 and L175G25C4G were tested for the potential to cause eye irritation in a GLP guideline studies according to OECD 405.

Both variations did not exhibit eye irritation or eye corrosion.

The results of the 2 studies on eye irritation reveal the same profile for both variations. The same result is expected for other variations of the substance pentaaluminium triyttrium dodecaoxide.

Sensitisation

The variations L181 and L175G25C4G were tested for their skin sensitising potential in GLP guideline studies according to OECD 429 (modified).

Both variations did not reveal any sensitising properties in the local lymph node assay (modified).

The same result is expected for other variations of the substance pentaaluminium triyttrium dodecaoxide.

Genetic Toxicity

The variations L181 and L175G25C4G were tested for genetic toxicity in vitro.

The substance is completely insoluble in water, DMSO, ethanol, acetone, tetrahydrofurane or isopropanol. The substance is not bioavailable for the bacterial cell in the Ames test or other in vitro test methods due to its insolubility. The substance is not capable of interfering with the genome in the bacterial cell. Hence, the Ames-test is negative as a basic principle.

The same applies for potential mutagenic activity under natural conditions both for L181 and L175G25C4G as well as other variations of the substance pentaaluminium triyttrium dodecaoxide.

Based on the data available no classification is required.