Registration Dossier
Registration Dossier
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EC number: 284-535-7 | CAS number: 84929-51-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Thymus vulgaris, Labiatae.
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Data comes from an online compilation using secondary data sources. There is no experimental study reference, however data provided from validated QSAR.
- Qualifier:
- according to guideline
- Guideline:
- other: ECOSAR
- Version / remarks:
- v1.11
- GLP compliance:
- not specified
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- ca. 1.087 mg/L
- Conclusions:
- LC50 of daphnia is 1.087 mg/L for carvacrol.
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Data comes from an online compilation using secondary data sources. There is no experimental study reference, however data provided from validated QSAR.
- Qualifier:
- according to guideline
- Guideline:
- other: ECOSAR
- Version / remarks:
- v1.11
- GLP compliance:
- not specified
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- ca. 0.278 mg/L
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- LC50 of daphnia is 0.278 mg/L for gamma-terpinene.
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Data comes from an online compilation using secondary data sources. There is no experimental study reference, however data provided from validated QSAR.
- Qualifier:
- according to guideline
- Guideline:
- other: ECOSAR
- Version / remarks:
- v1.11
- GLP compliance:
- not specified
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- ca. 0.29 mg/L
- Validity criteria fulfilled:
- not specified
- Conclusions:
- LC50 of daphnia is 0.29 mg/L for linalol.
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Data comes from an online compilation using secondary data sources. There is no experimental study reference, however data provided from validated QSAR.
- Qualifier:
- according to guideline
- Guideline:
- other: ECOSAR
- Version / remarks:
- v1.11
- GLP compliance:
- not specified
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1.213 mg/L
- Validity criteria fulfilled:
- not specified
- Conclusions:
- LC50 of daphnia is 1.213 mg/L for p-cymene.
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Data comes from an online compilation using secondary data sources. There is no experimental study reference, however data provided from validated QSAR.
- Qualifier:
- according to guideline
- Guideline:
- other: ECOSAR
- Version / remarks:
- v1.11
- GLP compliance:
- not specified
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1.098 mg/L
- Validity criteria fulfilled:
- not specified
- Conclusions:
- LC50 of daphnia is 1.087 mg/L for thymol.
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Data comes from an online compilation using secondary data sources. There is no experimental study reference, however data provided from validated QSAR.
- Qualifier:
- according to guideline
- Guideline:
- other: ECOSAR
- Version / remarks:
- v1.11
- GLP compliance:
- not specified
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- ca. 0.019 mg/L
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- LC50 of daphnia is 0.019 mg/L for beta-caryophyllene
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Data comes from an online compilation using secondary data sources. There is no experimental study reference, however data provided from validated QSAR.
- Qualifier:
- according to guideline
- Guideline:
- other: ECOSAR
- Version / remarks:
- v1.11
- Principles of method if other than guideline:
- QSAR method
- GLP compliance:
- not specified
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- ca. 13.38 mg/L
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- LC50 of daphnia is 13.380 mg/L for borneol.
Referenceopen allclose all
Description of key information
Based on a weight of evidence approach, the toxicity of assessed substance to daphnia during 48 hours can be estimated using adequate toxicity data of the major constituents, greater than 1% in the mixture.
Seven major constituents were considered, representing about 80% of the mixture.
The toxicity to daphnia were estimated using the following additivity formulas, as recommended in the Regulation (EC) No 1272/2008 (CLP) section 4.1.3.5.2:
∑ Ci / L(E)C50m = ∑ (Ci / L(E)C50i)
Where,Ci = concentration of component i (weight percentage);
L(E)C50i = LC50 or EC50 for component i, in mg/L; L(E)C50m = L(E)C50 of the part of the mixture with test data.
Based on data presented below, the EC50 value 48 hours for UVCB substance is calculated at 0.341 mg/L for daphnia.
These data are summarized in the table below :
| Mains consituents | CAS Number | LC50 daphnia 48h (mg/L) | Source | |
| Thymol (at 39.2%) | 89-83-8 | 1.087 | ECOSAR v1.11 | |
| P-cymene (at 18%) | 99-87-6 | 1.213 | ECOSAR v1.11 | |
| Gamma-terpinene (at 11%) | 99-85-4 | 0.278 | ECOSAR v1.11 | |
| Linalol (at 4.55%) | 78-70-6 | 0.290 | ECOSAR v1.11 | |
| Carvacrol (at 2.25%) | 499-75-2 | 1.087 | ECOSAR v1.11 |
|
| Beta-caryophyllene (at 2.4%) | 87-44-5 | 0.019 | ECOSAR v1.11 | |
| Borneol (at 2.7%) | 507-70-0 | 13.38 | ECOSAR v1.11 | |
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.341 mg/L
Additional information
With a LC50 daphnia value of 0.341 mg/l, the substance is classified H411 according to the table 4.1.0 b. i (as the substance is not readily biogradable) of CLP regulation.
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.
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