Registration Dossier
Registration Dossier
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EC number: 283-518-1 | CAS number: 84650-59-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Illicium verum, Illiciaceae.
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Study period:
- 2021-2022
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Study period:
- 2021-2022
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The dose addition model and the toxicity information of component chemicals in sample
- GLP compliance:
- no
- Species:
- rat
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 37 mg/kg bw/day (nominal)
- Based on:
- other: Typical concentration of the 10 most present constituents
- Sex:
- male/female
- Basis for effect level:
- other: Critical effects identified in toxicological studies
- Critical effects observed:
- no
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 37 mg/kg bw/day (nominal)
- Based on:
- other: Typical concentration of the 10 most present constituents
- Sex:
- male/female
- Basis for effect level:
- other: Critical effects identified in toxicological studies
- Critical effects observed:
- no
- Reproductive effects observed:
- no
- Conclusions:
- Therefore, based on the dose addition model and the toxicological data of the 10 most present constituents, representing 96.9% of the registered substance, the NOAEL for reproduction/developmental toxicity of the sample are calculated as 37 mg/kg bw/day for rats.
- Executive summary:
In this document designed to address a reproductive/developmental toxicity and a repeated dose toxicity assessment of the Star Anise Oil, initial information concerning the determination of oral toxicity after repeated doses administration and possible effects on male and female reproductive performance using the individual toxicity of each constituent of the complex substance are generated.
It allows to fulfil the standard information requirements requested under Annex VIII to the Regulation (EC) No 1907/2006 (i.e. the short-term repeated dose toxicity (28 days) and the screening for reproductive/developmental toxicity data).
The Reproduction/Developmental toxicity and subchronic oral toxicity information on individual constituents of the Star Anise Oil (i.e. the NOAEL) are collected from public data on the ECHA disseminated dossiers and/or on articles from scientific literature. In a conservative approach, if more than one study is available, the lowest No-Observed-Adverse-Effect-Level (NOAEL) is retained for the assessment.
For the toxicity assessment, in the absence of data on the whole mixture or a similar mixture, the risk assessment was based on the toxic properties of the 10 most present constituents, representing 96.9% of the registered substance. In this purpose, the mechanism of toxicity of the chemicals concerned is simulated from a computer predictive model. Although some structural alert for DNA and protein binding models were found, the lack of reactivity of the chemicals is confirmed from the predictions on the Cramer rules and the Verhaar system models, and the mode of action of these chemicals is expected to be similar for almost all of them. Therefore, the toxicologically similar chemicals approach is used for toxicity assessment of the mixture and corresponds to the most conservative dose addition model of the exposure level of the mixture, using the Hazard Index method. The formula used represents dose addition as a sum of exposures scaled by each chemical’s relative toxicity. This method of calculation includes uncertainties but is very conservative.
From the equation and the toxicity information of component chemicals in sample, the reproduction/developmental and subchronic oral toxicity of the sample are calculated at 37 and 236 mg/kg bw/day for rats, respectively.
Therefore, based on the dose addition model and the toxicological data of the 10 most present constituents, representing 96.9% of the registered substance, the NOAEL for reproduction/developmental toxicity and subchronic oral toxicity of the sample are calculated as 37 and 236 mg/kg bw/day for rats, respectively.
Data source
Reference
- Reference Type:
- other: Position paper
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The dose addition model and the toxicity information of component chemicals in sample
- GLP compliance:
- no
Test material
- Reference substance name:
- Star anise, Illicium verum, ext.
- EC Number:
- 283-518-1
- EC Name:
- Star anise, Illicium verum, ext.
- Cas Number:
- 84650-59-9
- Molecular formula:
- NA
- IUPAC Name:
- 1-methoxy-4-[(1E)-prop-1-en-1-yl]benzene
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
Results and discussion
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 236 mg/kg bw/day (nominal)
- Based on:
- other: Typical concentration of the 10 most present constituents
- Sex:
- male/female
- Basis for effect level:
- other: Critical effects identified in toxicological studies
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Therefore, based on the dose addition model and the toxicological data of the 10 most present constituents, representing 96.9% of the registered substance, the NOAEL for subchronic oral toxicity of the sample are calculated as 236 mg/kg bw/day for rats.
- Executive summary:
In this document designed to address a reproductive/developmental toxicity and a repeated dose toxicity assessment of the Star Anise Oil, initial information concerning the determination of oral toxicity after repeated doses administration and possible effects on male and female reproductive performance using the individual toxicity of each constituent of the complex substance are generated.
It allows to fulfil the standard information requirements requested under Annex VIII to the Regulation (EC) No 1907/2006 (i.e. the short-term repeated dose toxicity (28 days) and the screening for reproductive/developmental toxicity data).
The Reproduction/Developmental toxicity and subchronic oral toxicity information on individual constituents of the Star Anise Oil (i.e. the NOAEL) are collected from public data on the ECHA disseminated dossiers and/or on articles from scientific literature. In a conservative approach, if more than one study is available, the lowest No-Observed-Adverse-Effect-Level (NOAEL) is retained for the assessment.
For the toxicity assessment, in the absence of data on the whole mixture or a similar mixture, the risk assessment was based on the toxic properties of the 10 most present constituents, representing 96.9% of the registered substance. In this purpose, the mechanism of toxicity of the chemicals concerned is simulated from a computer predictive model. Although some structural alert for DNA and protein binding models were found, the lack of reactivity of the chemicals is confirmed from the predictions on the Cramer rules and the Verhaar system models, and the mode of action of these chemicals is expected to be similar for almost all of them. Therefore, the toxicologically similar chemicals approach is used for toxicity assessment of the mixture and corresponds to the most conservative dose addition model of the exposure level of the mixture, using the Hazard Index method. The formula used represents dose addition as a sum of exposures scaled by each chemical’s relative toxicity. This method of calculation includes uncertainties but is very conservative.
From the equation and the toxicity information of component chemicals in sample, the reproduction/developmental and subchronic oral toxicity of the sample are calculated at 37 and 236 mg/kg bw/day for rats, respectively.
Therefore, based on the dose addition model and the toxicological data of the 10 most present constituents, representing 96.9% of the registered substance, the NOAEL for reproduction/developmental toxicity and subchronic oral toxicity of the sample are calculated as 37 and 236 mg/kg bw/day for rats, respectively.
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.
