Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.7 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

As indicated in Assessment Report prepared in the context of the possible inclusion of the substance in Annex I of Directive 91/414/EEC prepared by the Hellenic Ministry of rural development and food (April 2008):

Hydrolysed proteins are natural compounds derived by the hydrolysis of tissues from living organisms that can be of plant or animal origin.

 

The Animal and Vegetable cells are formed mainly by proteins, which constitute more than the half of the dry weight of the cell. Proteins determine the shape and structure of the cell and also function as an instrument of molecular recognition and of catalysis (ALBERTS, 1986).

 

Proteins have many different biological functions. The widest group of proteins are the enzymes whose function is about catalysing the biochemical processes that take place in the living organisms. Moreover, there are proteins of reservation of amino acids such as plant nutrients; transport proteins of specific molecules; proteins that work as essential elements of the motile and contractile systems; protective proteins that are present in the blood of the vertebrates such as antibodies; proteins that function as hormones and, finally, structural proteins (LEHNINGER, 1983).

The proteins that are found in food and eaten by human beings and mammals are normally degraded metabolically by means of enzymatic processes to give rise to more simple metabolites (peptides and amino acids) that are used by the live cells for the biosynthesis of new specific proteins.

The hydrolysed protein comes from the enzymatic hydrolysis of the animal tissues. Therefore, they do not cause any danger to human beings and mammals in general. As it has been explained before, proteins appear in all biochemical processes that take place in every live cell being, this way, essential compounds for human life.

 

Furthermore, hydrolysed proteins are authorized by the EU in order to be used as attractant in the elaboration of baits in combination with appropriate insecticides of the Organic Farming (Regulation EC 1488/97 annex 2, part B). This shows the innocuousness of these compounds, since the practice of this kind of agriculture is very demanding with the use of products that can be harmful to human beings. Also in Regulation (EC) No 1774/2002 of the European Parliament and the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption, hydrolysed proteins (molecular weight <10,000 Dalton) are allowed in feed animal products, ensuring the safety and the toxicology harmlessness of them.

 

Hydrolysed proteins does not cause skin or eye irritation, but in case of prolonged contact with eyes, rinse immediately with plenty of water. In case of contact with skin, rinse and wash with plenty of water and soap.

 

Taking into account all that has been exposed, Hydrolysed proteins are considered a secure substance for human beings and mammals in general.

Following to the evaluation of this Assessment Report, hydrolysed proteins were included in Annex I of Directive 91/414/EEC, as laid down in Commission Directive 2008/127/EC of 18 December 2008 and Commission Directive 2009/153/EC of 30 November 2009.

The DNELs for long-term exposure is derived from the no observed effect level in a 90–days repeated dose toxicity study performed according OECD guideline (Schauss, 2007). Since no adverse substance-related were noted, a NOAEL of 1000 mg/kg bw/day was estimated.

Worker:

In general, the calculation of DNEL is based on the observed effect level which has to be modified as described in R8 (ECHA, May 2008).

For the DNEL of systemic oral and dermal effects a correction of the starting point is not required, since the observed effect level was derived in a 90–day repeated dose toxicity study (Schauss, 2007).

Subsequently, following assessment factors are taken into account for the final DNEL calculation: interspecies differences (4), remaining interspecies-differences (2.5), intraspecies differences (5), exposure duration (6).

The resulting DNEL for systemic long-term oral effects of protein hydrolyzates (animal) is 3.3 mg/kg bw/d for workers.

An additional assessment factor (0.5) was used to consider the difference in dermal absorption properties of human and rat skin.

The resulting DNEL for systemic long-term dermal effects of protein hydrolyzates (animal) is 6.7 mg/kg bw/d for workers.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.7 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.7 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

As indicated in Assessment Report prepared in the context of the possible inclusion of the substance in Annex I of Directive 91/414/EEC prepared by the Hellenic Ministry of rural development and food (April 2008):

Hydrolysed proteins are natural compounds derived by the hydrolysis of tissues from living organisms that can be of plant or animal origin.

 

The Animal and Vegetable cells are formed mainly by proteins, which constitute more than the half of the dry weight of the cell. Proteins determine the shape and structure of the cell and also function as an instrument of molecular recognition and of catalysis (ALBERTS, 1986).

 

Proteins have many different biological functions. The widest group of proteins are the enzymes whose function is about catalysing the biochemical processes that take place in the living organisms. Moreover, there are proteins of reservation of amino acids such as plant nutrients; transport proteins of specific molecules; proteins that work as essential elements of the motile and contractile systems; protective proteins that are present in the blood of the vertebrates such as antibodies; proteins that function as hormones and, finally, structural proteins (LEHNINGER, 1983).

The proteins that are found in food and eaten by human beings and mammals are normally degraded metabolically by means of enzymatic processes to give rise to more simple metabolites (peptides and amino acids) that are used by the live cells for the biosynthesis of new specific proteins.

The hydrolysed protein comes from the enzymatic hydrolysis of the animal tissues. Therefore, they do not cause any danger to human beings and mammals in general. As it has been explained before, proteins appear in all biochemical processes that take place in every live cell being, this way, essential compounds for human life.

 

Furthermore, hydrolysed proteins are authorized by the EU in order to be used as attractant in the elaboration of baits in combination with appropriate insecticides of the Organic Farming (Regulation EC 1488/97 annex 2, part B). This shows the innocuousness of these compounds, since the practice of this kind of agriculture is very demanding with the use of products that can be harmful to human beings. Also in Regulation (EC) No 1774/2002 of the European Parliament and the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption, hydrolysed proteins (molecular weight <10,000 Dalton) are allowed in feed animal products, ensuring the safety and the toxicology harmlessness of them.

 

Hydrolysed proteins does not cause skin or eye irritation, but in case of prolonged contact with eyes, rinse immediately with plenty of water. In case of contact with skin, rinse and wash with plenty of water and soap.

 

Taking into account all that has been exposed, Hydrolysed proteins are considered a secure substance for human beings and mammals in general.

The DNELs for long-term exposure is derived from the no observed effect level in a 90–days repeated dose toxicity study performed according OECD guideline (Schauss, 2007). Since no adverse substance-related were noted, a NOAEL of 1000 mg/kg bw/day was estimated.

General Population:

In general, the calculation of DNEL is based on the observed effect level which has to be modified as described in R8 (ECHA, May 2008).

For the DNEL of systemic oral and dermal effects a correction of the starting point is not required, since the observed effect level was derived in a 90–day repeated dose toxicity study (Schauss, 2007).

Subsequently, following assessment factors are taken into account for the final DNEL calculation: interspecies differences (4), remaining interspecies-differences (2.5), intraspecies differences (10), exposure duration (6).

The resulting DNEL for systemic long-term oral effects of protein hydrolyzates (animal) is 1.66 mg/kg bw/d for general population.

An additional assessment factor (0.5) was used to consider the difference in dermal absorption properties of human and rat skin.

The resulting DNEL for systemic long-term dermal effects of protein hydrolyzates (animal) is 3.3 mg/kg bw/d for general population.