Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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

No acute or long-term toxicity study is provided because due to the nature of the substance, Algifert solid K+ is not deemed to pose any toxicological hazard. In fact, algae and algal products are used as food for humans and animals: about 60 out of the 20000 species of algae described so far are widely used in the food, pharmaceutical and cosmetic industries. The brown algae belonging to the genus  Ascophyllum are included.

The dominant use of brown algal seaweed is for the production of phycocolloids such as alginates.In cosmetology, alginates extracted from Ascophyllum are used as emulsifiers and emulsion stabilizers in creams and lotions, as excipients absorbable by the epidermis, in preparations such as gels, creams, shampoos. Alginates are recognized world-wide as products that may be used freely in foodstuffs as emulsifying or stabilising agents. Accordingly, they are considered safe for use in skin applications and are well tolerated (Y. De Roeck – Holtzhauer, 1991, 4 Uses of Seaweeds in Cosmetics, in Seaweed resources in Europe: Uses and Potential).

The brown algal seaweed is used also in animal and human nutrition; in particular Ascophyllum nodosum is used as seaweed meal in

Iceland, Scotland, Ireland, Norway, UK.

Animal nutrition: is the most common seaweed source in animal nutrition in Europe is ; most data on its use are from Norway where it has been used since 1937 in feeding stuff for poultry, chick and hen trials, sheep, cattle, pig, horses, mink and as a supplemental fodder for poultry, pig, cattle and sheep in Iceland, Scotland, Ireland, Norway, Finland, France, New Zealand (W. A. Stephenson, 1973. 10 Seaweed meal as feeding stuff, in Seaweed in agriculture and Horticulture).

Human nutrition: the use in human nutrition is more common in Far East, particularly in Japan, China and Korea, where the population eat more seaweed than in the West for both nutritional and industrial purposes. France is now the European country where seaweeds are used in human nutrition at the highest level. A. nodosum and L. digitata are among the species used due to their ability to regulate bowel action, as source of amino acids and protein, vitamins and minerals and low fat content.

Furthermore, seaweed extracts including Ascophyllum nodosum extracts are included in Annex I of Directive 91/414/EEC, which requires a reduced package of studies for Plant Protection Products made from plants or plants extracts (SANCO Draft Working Document 10472/2003/rev. 5). According to this document, for algal species used in food and feed, oral toxicity tests may be waived.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown (no further information necessary)

Additional information - General Population

No acute or long-term toxicity study is provided because due to the nature of the substance, Algifert solid K+ is not deemed to pose any toxicological hazard. In fact, algae and algal products are used as food for humans and animals: about 60 out of the 20000 species of algae described so far are widely used in the food, pharmaceutical and cosmetic industries. The brown algae belonging to the genus  Ascophyllum are included.

The dominant use of brown algal seaweed is for the production of phycocolloids such as alginates.In cosmetology, alginates extracted from Ascophyllum are used as emulsifiers and emulsion stabilizers in creams and lotions, as excipients absorbable by the epidermis, in preparations such as gels, creams, shampoos. Alginates are recognized world-wide as products that may be used freely in foodstuffs as emulsifying or stabilising agents. Accordingly, they are considered safe for use in skin applications and are well tolerated (Y. De Roeck – Holtzhauer, 1991, 4 Uses of Seaweeds in Cosmetics, in Seaweed resources in Europe: Uses and Potential).

The brown algal seaweed is used also in animal and human nutrition; in particular Ascophyllum nodosum is used as seaweed meal in

Iceland, Scotland, Ireland, Norway, UK.

Animal nutrition: is the most common seaweed source in animal nutrition in Europe is ; most data on its use are from Norway where it has been used since 1937 in feeding stuff for poultry, chick and hen trials, sheep, cattle, pig, horses, mink and as a supplemental fodder for poultry, pig, cattle and sheep in Iceland, Scotland, Ireland, Norway, Finland, France, New Zealand (W. A. Stephenson, 1973. 10 Seaweed meal as feeding stuff, in Seaweed in agriculture and Horticulture).

Human nutrition: the use in human nutrition is more common in Far East, particularly in Japan, China and Korea, where the population eat more seaweed than in the West for both nutritional and industrial purposes. France is now the European country where seaweeds are used in human nutrition at the highest level. A. nodosum and L. digitata are among the species used due to their ability to regulate bowel action, as source of amino acids and protein, vitamins and minerals and low fat content.

Furthermore, seaweed extracts including Ascophyllum nodosum extracts are included in Annex I of Directive 91/414/EEC, which requires a reduced package of studies for Plant Protection Products made from plants or plants extracts (SANCO Draft Working Document 10472/2003/rev. 5). According to this document, for algal species used in food and feed, oral toxicity tests may be waived.