Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 258-887-7 | CAS number: 53956-04-0
Endpoint summary
Administrative data
Description of key information
See "Justification for Classification"
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Remarks:
- peer-reviewed monograph
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- not specified, methods can be inferred from the results
- GLP compliance:
- not specified
- Test type:
- other: Test type not provided
- Limit test:
- no
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- not specified
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 12 700 mg/kg bw
- Based on:
- not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item has a very low acute toxicity (oral) with an LD50 of 12700 mg/kg in mice.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- not specified
- GLP compliance:
- not specified
- Remarks:
- no information in the publication
- Test type:
- other: Test type not provided
- Limit test:
- no
- Species:
- other: rats and mice
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- not specified
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 18 other: g/kg
- Based on:
- not specified
- Remarks on result:
- other: Rats
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 14.2 other: g/kg
- Based on:
- not specified
- Remarks on result:
- other: Rats
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 7.5 other: g/kg
- Based on:
- not specified
- Remarks on result:
- other: Mice
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Licorice extract (53% glycyrrhizin, containing Ammonium glycyrrhizinate) LD50 is 18 g/kg in male rats, 14.2 g/kg in female rats, and >7.5 g/kg in mice.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 12 700 mg/kg bw
Additional information
Justification for classification or non-classification
Acute oral toxicity : two secondary citations are available from publications with limited details on methods and test item (both Klimisch 4):
- Ammonium glycyrrhizinate LD50 is 12.7 g/kg bw in mice.
- Licorice extract (53% glycyrrhizin, containing Ammonium glycyrrhizinate) LD50 is 18 g/kg in male rats, and 14.2 g/kg in female rats. In mice, the DL50 is greater than 7.5 g/kg.
Although one of the reports used for the acute toxicity oral assessment was made on the basis of glycyrrhizin rather than on pure ammonium glycyrrhizate (both being licorice constituents), and despite the lack of information about the test methods, overall these values are good indicators of an extremely low ammonium glycyrrhizate acute oral toxicity.
The fixed value in mice (12.7 g/kg) is kept as a worst-case, after eliminating the lower-limit value in mice (>7.5 g/kg).
No classification is needed according to both CLP and GHS.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
