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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
acute toxicity: oral
Type of information:
other: Published LD50 values for iso-alpha acids and rho-iso-alpha acids are cited in a company report and in a recent scientific publication.
Adequacy of study:
weight of evidence
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
equivalent or similar to guideline
other: Data obtained from closely related molecules, on which from GRAS assessment
GLP compliance:
not specified
Test type:
other: Data obtained from GRAS assessment
other: rat data cited in GRAS assessment
Key result
Dose descriptor:
Effect level:
ca. 1 000 mg/kg bw
Interpretation of results:
Category 4 based on GHS criteria
Notes from attached justification: "Safety assessments of tetrahydroiso-α-acids were discussed in detail in company report BI/YYF/REACH/2007-001.1 In summary:

• The reduced derivatives are approved food additives for beer in the USA, under 21 CFR § 172.560.6 Safety assessments of these compounds have been performed.
• BI/YYF/REACH/2007-0011 provides discussions of acute dermal toxicity, acute inhalation toxicity, sub-acute toxicity studies, animal and human studies, mutagenicity and genotoxicity studies on iso-α-acids, rho-iso-α-acids, and tetrahydroiso-α-acids, which can be considered together using a read-across approach.
• The acute toxicity of tetrahydroiso-α-acids can be read across from LD50 values of 1,000 mg per kg for iso-α-acids and rho-iso-α-acids: see BI/YYF/REACH/2007-0011 and Karabin et al. (2016).

Since LD50 values for the closely-related iso-α-acids and rho-iso-α-acids have been quoted in the scientific literature, further animal studies are not warranted."

In addition: "Interestingly, the potassium salt of tetrahydroisohumulone has been tested as a potential drug for improving metabolism in prediabetic humans in a clinical research centre. .... Key points taken from the safety assessment detailed in the article are as follows:

• No cases of stopping the drug or of altering the dose
• All adverse effects were mild or moderate, and all resolved spontaneously
• The adverse effects were mostly gastrointestinal effects
• No evidence of greater toxicity with higher serum levels of KDT501
• No significant findings in clinical laboratory evaluations
• No evidence of liver, kidney or bone marrow toxicity"
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
1 000 mg/kg bw

Additional information

Justification for classification or non-classification