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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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.
Toxicological information
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data considered reliable by ECHA.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Unknown
- GLP compliance:
- not specified
- Details on oral exposure:
- LD50 Rat oral 3650mg/kg.Source Food and Cosmetics Toxicology.Vol. 14,Pg.875,1976
- Dose descriptor:
- LD50
- Effect level:
- 3 650 mg/kg bw
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- LD50 Rat oral 3650mg/kg.The substance is classified as a category 5 GHS regulation.
- Endpoint:
- acute toxicity: oral
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data considered reliable by ECHA.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Unknown
- GLP compliance:
- not specified
- Details on oral exposure:
- LD50 Rat oral 2790 mg/kg (2440-3180, 95% CL) /From table/[Organization for Economic Cooperation and Development; Screening Information Data Set for LINALOOL (78-70-6) p.13 (March 2002). Available from, as of July 15, 2008: http://www.chem.unep.ch/irptc/sids/OECDSIDS/sidspub.html] **PEER REVIEWED**
- Dose descriptor:
- LD50
- Effect level:
- 2 790 mg/kg bw
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- LD50 Rat oral 2790 mg/kg. The substance is classified as a category 5 GHS regulation.
- Endpoint:
- acute toxicity: oral
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data considered reliable by ECHA.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Unknown
- GLP compliance:
- not specified
- Details on test animals or test system and environmental conditions:
- LD50 Rat oral 4750 mg/kg [O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Whitehouse Station, NJ:Merck and Co., Inc., 2006., p. 464] **PEER REVIEWED**
- Dose descriptor:
- LD50
- Effect level:
- ca. 4 750 mg/kg bw
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 rat oral 4750 mg/kg body weight. The substance is classified as a category 5 GHS regulation.
- Endpoint:
- acute toxicity: oral
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data considered reliable by ECHA.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Unknown
- GLP compliance:
- not specified
- Details on oral exposure:
- LD50 Mouse oral 640 mg/kg [Lewis, R.J. Sr. (ed) Sax's Dangerous Properties of Industrial Materials. 11th Edition. Wiley-Interscience, Wiley & Sons, Inc. Hoboken, NJ. 2004., p. 3463] **PEER REVIEWED**
LD50 Rat oral 980 mg/kg [Lewis, R.J. Sr. (ed) Sax's Dangerous Properties of Industrial Materials. 11th Edition. Wiley-Interscience, Wiley & Sons, Inc. Hoboken, NJ. 2004., p. 3463] **PEER REVIEWED** - Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 650 mg/kg bw
- Based on:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 980 mg/kg bw
- Based on:
- not specified
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 rat oral 980 mg/kg body weight
LD50 mouse oral 640 mg/kg body weight. - Endpoint:
- acute toxicity: oral
- Type of information:
- other: bibliography
- Adequacy of study:
- other information
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data considered reliable by ECHA.
- Qualifier:
- no guideline available
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- >= 3 750 - <= 5 670 mg/kg bw
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral LD50 value in rats was reported as 4700 mg/kg (3570-5670 mg/kg).
The classification of thym oil red is category 5. - Endpoint:
- acute toxicity: oral
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Qualifier:
- according to guideline
- Guideline:
- other: section 3.1.3.6.2.3 of 1272/2008 EC regulation
- Principles of method if other than guideline:
- Based on a weight of evidence approach, the acute toxicity oral of this UVCB substance can be estimated using adequate toxicity data of major constituents, greater than 4.55% in the mixture.
4 constituents were considered, representing 72.75% of the mixture. These data are summarized in the table below.
The acute toxicity oral was estimated using the following additivity formula, as recommended in the Regulation (EC) No 1272/2008 (CLP) part 3.1.3.6.2.3.:
100-(∑ Ci unkown if > 10 %) / ETA mix = ∑ (Ci / ETAi)Where,Ci = concentration of component i (weight percentage); i = the individual ingredient from 1 to n ; n = the number of ingredients ; ATE i = Acute Toxicity Estimate of ingredient i. - Sex:
- not specified
- Dose descriptor:
- approximate LD50
- Effect level:
- ca. 1 602 mg/kg bw
- Based on:
- other: calculation according to additivity formula of CLP regulation section 3.1.3.6.2.3.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- With a LD50 oral estimated at 1602 mg/kg, the thyme oil is classified H302 according to CLP criteria and GHS criteria.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Monograph used by the fragrance industry.
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- RIFM protocol in 1973
- GLP compliance:
- no
- Species:
- rat
- Key result
- Sex:
- not specified
- Dose descriptor:
- approximate LD50
- Effect level:
- > 3 750 - < 5 670 mg/kg bw
- Based on:
- not specified
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral LD50 value in rats was reported 4.70 g/kg (Moreno, 1973).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 980 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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.
