Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation/corrosion:

For skin irritation/corrosion, the study does not need to be conducted because the Bos Taurus, milk, fermented, spray-dried (EC  917-734-0) is classified using a worst-case approach considering the classification of the L (+) Lactic Acid (CAS-No. 79-33-4, EC-No. 201-196-2).According to the CLP Regulation, the concentration triggering classification of a mixture as skin corrosion Cat. 1 is = 5%, and the concentration triggering classification as skin irritation Cat. 2 is between 1 and <5%. In the case of Bos Taurus, milk, fermented, spray-dried (EC  917-734-0), the concentration of Lactic Acid (CAS-No. 50-21-5, EC-No. 200-018-0) is 2.5-4.9%. Therefore, we classify Bos Taurus, milk, fermented, spray-dried (EC  917-734-0) as ‚Skin Irritation’ Cat.2 (H315).

 

Eye irritation:

For eye irritation, the study does not need to be conducted because the Bos Taurus, milk, fermented, spray-dried (EC 917-734-0) is classified using a worst-case approach considering the classification of the L (+) Lactic Acid (CAS-No. 79-33-4, EC-No. 201-196-2). According to the CLP Regulation, the concentration triggering classification of a mixture classified as eye irritation/eye damage Cat. 1 is 3%. In the case of Bos Taurus, milk, fermented, spray-dried (EC 917-734-0), the concentration of L (+) Lactic Acid (CAS-No. 79-33-4, EC-No. 201-196-2) is 2.5-4.9%. Therefore, we classify Bos Taurus, milk, fermented, spray-dried (EC 917-734-0) as ‚Causes serious eye damage’ Cat. 1 (H318).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
The study does not need to be conducted because the Bos Taurus, milk, fermented, spray-dried (EC  917-734-0) is classified using a worst-case approach considering the classification of the L (+) Lactic Acid (CAS-No. 79-33-4, EC-No. 201-196-2). For further details please consult the attachment.
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
The study does not need to be conducted because the Bos Taurus, milk, fermented, spray-dried (EC  917-734-0) is classified using a worst-case approach considering the classification of the L (+) Lactic Acid (CAS-No. 79-33-4, EC-No. 201-196-2). For further details please consult the attachment.
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
The study does not need to be conducted because the substance is classified using a worstcase approach considering the classification of the L(+) Lactic Acid (CAS-No. 79-33-4, EC-No. 201-196-2). For further details please consult the attachment.
Endpoint:
eye irritation: in vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
The study does not need to be conducted because the substance is classified using a worstcase approach considering the classification of the L(+) Lactic Acid (CAS-No. 79-33-4, EC-No. 201-196-2). For further details please consult the attachment.
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification