Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving

Workers - Hazard for the eyes

Additional information - workers

According to Regulation (EC) No. 1272/2008, Triethanol amineacetate does not meet the criteria to be classified as dangerous.

 

Different dermal studies shows that Triethanol amineacetate is not dangerous and no further dermal effects are expected on workers. Moreover,worker’s inhalation exposure during manufacture and industrial use of Triethanol amineacetate is unlikely to occur due to the substance is manufactured and used in aqueous solution, and pure substance has a very low vapour pressure (0.116 Pa at 20 ºC).

 

Based on the exposure assessment, the manufacture and industrial uses of Triethanol amineacetate are carried out under controlled industrial and professional operational conditions with very low likelihood of exposure to workers. Triethanol amineacetate is used as a grinding agent in the production of cement. The substance is mixed with cement and aids in the grinding process which produces powdered cement, the Triethanol amineacetate present into cement matrix degrades during further cement manufacturing process and is present in very low concentrations into final product with no further exposure to professionals, consumers or the environment expected.

 

Further to the low likelihood of exposure, all relevant exposure information through the whole life cycle of the substance in the supply chain is communicated to users enabling appropriate risk management measures to be identified and applied.

 

Therefore, based on the fact that exposure to workers is unlikely to occur, as well as the lack of evidence that the substance presents a toxicological risk to human health, safety thresholds for dermal and inhalation effects do not need to be calculated.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Triethanol amineacetate is manufactured for industry’s own use in the manufacturing process for cement as a grinding agent. Risk management measures are implemented at the manufacturing sites to ensure that no accidental environmental release of the substance will occur. The general population is not expected to be exposed to Triethanol amineacetate at any stage in the lifecycle of the substance and as such, a discussion on exposure to this group is not considered to be relevant.

Based on the exposure assessment, the use of Triethanol amineacetate is carried out under controlled industrial and professional operational conditions as grinding agents in the production of cement. The substances are mixed with cement and they act to aid the grinding process which produces powdered cement. Expected concentration of the Triethanol amineacetate into the final mixture/article from the life cycle is negligible and not expected to be released from cement.

Further to the low likelihood of exposure, all relevant exposure information through the whole life cycle of the substance in the supply chain is communicated to users enabling appropriate risk management measures to be identified and applied.

 

Therefore, based on the fact that there is no expected exposure to the general population, as well as the lack of evidence that the substance presents a toxicological risk to human health, safety thresholds for dermal and inhalation effects do not need to be calculated for the general population.