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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Due to legal reasons it is not justified to perform this studies.

The substance is used solely for cosmetic uses. According to Directive 76/768/EEC (Cosmetics Directive) and in Regulation 1223/2009/EC (Cosmetics Regulation) it is not allowed to perform animal tests, although cosmetic raw materials are subject to restriction (marketing ban). Therefore the test on acute oral toxicity has to be waived.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Due to legal reasons it is not justified to perform this studies. The substance is used solely for cosmetic uses. According to Directive 76/768/EEC (Cosmetics Directive) and in Regulation 1223/2009/EC (Cosmetics Regulation) it is not allowed to perform animal tests, although cosmetic raw materials are subject to restriction (marketing ban). Therefore the test on acute oral toxicity has to be waived.


Justification for selection of acute toxicity – oral endpoint
Due to legal reasons it is not justified to perform this study. The substance is used solely for cosmetic uses. According to Directive 76/768/EEC (Cosmetics Directive) and in Regulation 1223/2009/EC (Cosmetics Regulation) it is not allowed to perform animal tests, although cosmetic raw materials are subject to restriction (marketing ban). Therefore the test on acute oral toxicity has to be waived.

Justification for classification or non-classification

Creatinine is an endogenous substance. Creatinine is a breakdown product of Creatine in muscle and is usually produced at a fairly constant rate by the body (depending on muscle mass). According to “Wissenschaftliche Tabellen, 7. Auflage, 1969, J.R. Geigy S.A., Basel, Schweiz” considerable amounts of Creatinine can be found in the different compartments and body fluids:

Cord blood plasm or serum: 11.8 mg/L (6.4 – 17.2 mg/L)

Blood plasm or serum, child (4-21 weeks): 9.5 mg/L (7.9 – 11.1 mg/L)

Blood plasm or serum, child (1-6 years): 11.9 mg/L (7.5 -16.3 mg/L)

Blood plasm or serum, adult:12.4 mg/L (6.6 – 18.2 mg/L)

Liquor cerebrospinalis: 6-14 mg/L

Gastric juice: 12-33 mg/L

Urine, male (20-45 years): 1.8 (1.2 - 2.5 g/24h)

Urine, female (20-45 years): 1.17 (0.01 - 1.33 g/24h)

Sweat: 4.6 mg/L (2.1 - 8.4 mg/L)

Mother’s milk: 11 mg/L (8 - 19 mg/L)

Furthermore Creatinine is part of the diet and can be found in lean meat in constant content of 0.02 – 0.04 % (G.Mayer, H.Knapp, RÖMPP, Thieme Verlag, 2009).

Therefore it can be assumed that Creatinine is not a toxic substance and should not be classified.