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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reference
Endpoint:
acute toxicity: oral
Type of information:
other: Published LD50 values for iso-alpha acids are cited and discussed in a GRAS assessment, and citred in a recent scientific publication.
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
equivalent or similar to guideline
Guideline:
other: Data obtained from GRAS assessment
GLP compliance:
not specified
Test type:
other: Data obtained from GRAS assessment
Species:
other: rat data cited in GRAS assessment
Key result
Dose descriptor:
LD50
Effect level:
ca. 1 000 mg/kg bw
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
LD50 values for iso-α-acids that have been reported in the scientific literature, from published and unpublished toxicity studies, were considered and summarised in a GRAS determination of hop iso-α-acids (2008). The LD50 value for isohumulone was reported in the scientific literature as 1,000 mg/kg body weight when administered to Sprague Dawley rats in a 50% corn-oil solution. The same value for LD50 is also quoted in a recent (2016) scientific review article by Karabin et al.*

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

* Karabin M, Hudcova T, Jelinek L and Dostalek P (2016) Biologically active compounds from hops and prospects for their use. Comprehensive Reviews in Food Science and Food Safety 15: 542-567. Accessed on 22 March 2017 on http://onlinelibrary.wiley.com/doi/10.1111/1541-4337.12201/pdf
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available
Dose descriptor:
LD50
Value:
1 000 mg/kg bw

Additional information

Justification for classification or non-classification