Bos taurus, milk, pasteurized, homogenized, skimmed, fermented, spray-dried

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Data waiving:

study waived due to provisions of other regulation

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING

The study does not need to be conducted because the majority of the tonnage is used in cosmetic end products. Consequently, the tonnage used for products other than cosmetics is far below 10 t/a and for that use alone a fish test would not be required (acc. to Annex VII).
According to the Cosmetics Regulation 1223/2009, any animal testing in cosmetic products or cosmetic raw materials cannot be conducted in the EU as of 11th September 2014 and cosmetics tested in animals, or whose ingredients have been tested on animals, cannot be placed in the EU market as of 11th March 2013. ECHA (REACH Factsheet, Interface between REACH and Cosmetics regulations, https://echa.europa.eu/documents/10162/13628/reach_cosmetics_factsheet_en.pdf) states that animal testing can be performed for all environmental endpoints established by REACH (whether or not the substance is only used for cosmetic purposes), but only as a last resort. It is not considered likely that a fish test would change the overall environmental risk of Yoghurt Powder (see CSR).

In addition, a search was conducted on the fish toxicity of the main components of Bos taurus milk, skimmed, fermented, spray-dried:
- data exist for lactic acid (CAS 50-21-5, registration dossier): LC50 (Fisch) = 130 mg/L, LC50 daphnia: 130 mg/L; algae EC50: 3.5 g/L = 3500 mg/L, however, these data do not lead to a classification of lactic acid, and furthermore, lactic acid is present in Bos taurus milk, skimmed, fermented, spray-dried only at max. 4.9%
- Lactose is exempted from REACH registration requirements according to REACH Annex IV (substances included in Annex IV, as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties) and can thus be considered to have non-critical properties)
- No fish toxicity data were found for milk proteins (e.g. peptones, casein (CAS-Nr. 91079-40-2) registration dossier)
- Hence, it was considered to conduct a QSAR for the milk proteins. However, Casein has appr. 200 amino acids, and even if a smaller form of casein could be used, e.g. https://pubchem.ncbi.nlm.
nih.gov/compound/73995022#section=Top (ca. 20 amino acids, MW > 2000 g/mol), the EPIweb ECOSAR tool is limited to a maximum of 1000 g/mol. Smaller proteins were not considered
representative. Hence, milk proteins were out of scope of the QSAR and no calculation could be conducted.
- Milk powder is a common ingredient in diverse fish feeding products. Hence, also Bos taurus milk, skimmed, fermented, spray-dried, which is similar, will not be toxic to fish.

=> Based on these data and the argumentation above, it was considered that an acute fish test does not have to be conducted.

Description of key information

Based on the collected data and the given argumentation, it was considered that an acute fish test does not have to be conducted.