Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 946-963-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Based on a Read across strategy, two extract from the same plant were found to have an oral LD50 greater than 5000 mg/kg(OECD 423 & OECD 420 in rats; GLP, K, rel.1), and in an acute dermal toxicity, an extract from the same botanical specie has a DL50 greater that 5000 mg/kg bw
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
- Study period:
- 08 - 23 August 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study performed according to OECD Guideline 423 with no deviation
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- dated 17 December, 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 27 April 2017
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER LABS, France
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 169-206 g
- Fasting period before study: overnight. Redistributed 4 hours after the test item administration.
- Housing: Animals were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet (e.g. ad libitum): Foodstuff (ENVIGO – 2016 Teklad Global 16% Protein Rodent Diet), ad libitum
- Water (e.g. ad libitum): Drinking water (tap-water from public distribution system), ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25°C
- Humidity: 30-70%
- Air changes: at least 10/hour
- Photoperiod: 12 hours dark / 12 hours light - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: ca. 2000 mg/10 mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Olive oil was chosen as it produced the most suitable formulation at the requested concentration.
DOSAGE PREPARATION: In the first and second step of the study, 2.0090 g and 2.0098 g of the test item were weighed and Olive oil was added to two 10 mL volumetric flasks. Just before the administration, the preparations were stirred by vortex then magnetically during 5 minutes at approximately 50°C to obtain thick brown solutions. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 female rats
- Control animals:
- no
- Remarks:
- Historical data
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations and mortality were recorded at 30 min, 1h, 3h, 4h, 24h, 48h after administration of the test item and continued daily during 14 days.. Animals were weighed on day D0 (just before administering the test item) and then on D2, D7, and D14.
- Necropsy of survivors performed: Yes; animals were euthanized with sodium pentobarbital (Dolethal®) on D14 and macroscopic observations were noted. - Statistics:
- No data
- Preliminary study:
- Not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: estimated from the flow chart from OECD Guideline 423 (Appendix 2d)
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- No clinical signs related to the administration of the test item were observed during the study.
- Body weight:
- The body weight evolution of the animals remained normal throughout the study.
- Gross pathology:
- The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD50 of the test substance is >2000 mg/kg bw in rats. In accordance with OECD Guideline 423, the LD50 cut-off of the test substance may be considered to be higher than 5000 mg/kg bw by oral route in the rat. Therefore it is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and according to the Globally Harmonised System of classification and labelling of chemicals (GHS).
- Executive summary:
In an acute oral toxicity study performed according to the OECD Guideline 423 and in compliance with GLP, a single dose of 2000 mg/kg bw of the test substance solubilized in olive oil and heated during 5 minutes at ca. 50°C was given by oral gavage to a group of 6 female Sprague Dawley rats. Animals were then observed for mortality, clinical signs and body weight changes for 14 days, and were all sacrificed for macroscopic examinations.
No mortality occurred during the study. No clinical signs related to the administration of the test item were observed during the study The body weight evolution of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
Rat Oral LD50 >2000 mg/kg bw.
Under the test conditions, the oral LD50 of the test substance is >2000 mg/kg bw in rats. In accordance with OECD Guideline 423, the LD50 cut-off of the test substance may be considered to be higher than 5000 mg/kg bw by oral route in the rat. Therefore it is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and according to the Globally Harmonised System of classification and labelling of chemicals (GHS).
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- March 03 to 26, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD Guideline 420 without any deviation.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Programme (inspected on March 12 to 14, 2014/ signed on May 12, 2014)
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 159-176 g
- Fasting period before study: Animals were fasted for overnight period before dosing and for approximately 3-4 h after dosing.
- Housing: Animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: Food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: 15 changes / h
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: March 03 to 26, 2015 - Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: DMSO was used as vehicle because the test item did not dissolve/suspend in distilled water or arachis oil BP.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: For the purpose of the study, the test item was freshly prepared, as required, as a suspension in dimethyl sulphoxide. The test item was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable for this duration. - Doses:
- - Sighting study: 300 and 2000 mg/kg bw
- Main study: 2000 mg/kg bw - No. of animals per sex per dose:
- - Sighting study: 1 female/dose
- Main study: 5 females/dose (1 animal included from sighting study) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 0.5, 1, 2, and 4 h after dosing and then daily for 14 days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: Yes; at the end of the observation period, animals were killed by cervical dislocation and subjected to gross necropsy. - Statistics:
- None
- Preliminary study:
- - No mortality or clinical signs were observed at 300 mg/kg bw.
- The animal showed expected gains in body weight over the observation period.
- No abnormalities were noted at necropsy. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed at 2000 mg/kg bw.
- Clinical signs:
- No signs of systemic toxicity were noted during the observation period.
- Body weight:
- All animals showed expected gains in body weight over the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Rat Oral LD50 (females) > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP). - Executive summary:
In an acute oral toxicity study performed according to OECD Guideline 420 and in compliance with GLP, groups (5 females/dose) of Wistar (RccHan™:WIST) rats were given a single oral (gavage) dose of test item at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination. Sighting study was conducted at the dose levels of 300 and 2000 mg/kg bw (one female/dose) to determine the dose for main study.
In the sighting study, no mortality or clinical signs were observed at 300 mg/kg bw. The animal showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy. In the main study, no mortality or clinical signs were observed at 2000 mg/kg bw. All animals showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy.
Rat Oral LD50 (females) > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- Resinoid of Cistus ladaniferus (Cistaceae) obtained from labdanum gum by organic solvents extraction and Gum of Cistus ladaniferus (Cistaceae) obtained from stems and leaves by extraction with alkaline solution are extracted from the same botanical plant: Cistus ladaniferus (Cistaceae)
- Reason / purpose for cross-reference:
- read-across source
- Preliminary study:
- Not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: estimated from the flow chart from OECD Guideline 423 (Appendix 2d)
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- No clinical signs related to the administration of the test item were observed during the study.
- Body weight:
- The body weight evolution of the animals remained normal throughout the study.
- Gross pathology:
- The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD50 of the test substance is >2000 mg/kg bw in rats. In accordance with OECD Guideline 423, the LD50 cut-off of the test substance may be considered to be higher than 5000 mg/kg bw by oral route in the rat. Therefore it is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and according to the Globally Harmonised System of classification and labelling of chemicals (GHS). Therefore the registered substance is considered as non claissifed
- Executive summary:
In an acute oral toxicity study performed according to the OECD Guideline 423 and in compliance with GLP, a single dose of 2000 mg/kg bw of the test substance solubilized in olive oil and heated during 5 minutes at ca. 50°C was given by oral gavage to a group of 6 female Sprague Dawley rats. Animals were then observed for mortality, clinical signs and body weight changes for 14 days, and were all sacrificed for macroscopic examinations.
No mortality occurred during the study. No clinical signs related to the administration of the test item were observed during the study The body weight evolution of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
Rat Oral LD50 >2000 mg/kg bw.
Under the test conditions, the oral LD50 of the test substance is >2000 mg/kg bw in rats. In accordance with OECD Guideline 423, the LD50 cut-off of the test substance may be considered to be higher than 5000 mg/kg bw by oral route in the rat. Therefore it is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and according to the Globally Harmonised System of classification and labelling of chemicals (GHS).
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- Concrete of Cistus ladaniferus (Cistaceae) obtained from stems and leaves by organic solvents extraction and Gum of Cistus ladaniferus (Cistaceae) obtained from stems and leaves by extraction with alkaline solution are extracted from the same botanical plant: Cistus ladaniferus (Cistaceae)
- Reason / purpose for cross-reference:
- read-across source
- Limit test:
- no
- Preliminary study:
- - No mortality or clinical signs were observed at 300 mg/kg bw.
- The animal showed expected gains in body weight over the observation period.
- No abnormalities were noted at necropsy. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed at 2000 mg/kg bw.
- Clinical signs:
- No signs of systemic toxicity were noted during the observation period.
- Body weight:
- All animals showed expected gains in body weight over the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Rat Oral LD50 (females) > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP). Therefore the registered substance is considered as not classified. - Executive summary:
In an acute oral toxicity study performed according to OECD Guideline 420 and in compliance with GLP, groups (5 females/dose) of Wistar (RccHan™:WIST) rats were given a single oral (gavage) dose of test item at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination. Sighting study was conducted at the dose levels of 300 and 2000 mg/kg bw (one female/dose) to determine the dose for main study.
In the sighting study, no mortality or clinical signs were observed at 300 mg/kg bw. The animal showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy. In the main study, no mortality or clinical signs were observed at 2000 mg/kg bw. All animals showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy.
Rat Oral LD50 (females) > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP). Therefore the registered substance is considered as not classified.
Referenceopen allclose all
None
None
None
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not applicable
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Specific details on test material used for the study:
- clear, yellow liquid
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: from 2.5 to 3.0 Kg
- Housing: individually
- Diet : commercial diet
- Water ad libitum: - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 240 cm²
- % coverage: 10% of body surface - Duration of exposure:
- 24 hours
- Doses:
- 5 ml/kg
- No. of animals per sex per dose:
- 3 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily (toxic effects, dermal reactions and mortality)
- Necropsy of survivors performed: yes - Key result
- Dose descriptor:
- LD50
- Effect level:
- > 5 mL/kg bw
- Mortality:
- No mortality was observed.
- Clinical signs:
- Erythema and edema were observed
- Body weight:
- No data
- Gross pathology:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
- Executive summary:
In an acute dermal toxicity study (limit test), three rabbits were given a single dermal application of labdanum at 5000 mL/kg bw. Animals were observed for mortality and clinical signs for 14 days.
No mortality was observed. Edema and Erythema were observed.
In this study, the dermal LD50 of the test item was higher than 5000 mL/kg bw in rats.
Under the experimental conditions of this study, the test item is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- Labdanum oil and Labdanum gum are obtained from the same botanical source, the Cistus ladaniferus (Cistaceae).
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not applicable
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Specific details on test material used for the study:
- clear, yellow liquid
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: from 2.5 to 3.0 Kg
- Housing: individually
- Diet : commercial diet
- Water ad libitum: - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 240 cm²
- % coverage: 10% of body surface - Duration of exposure:
- 24 hours
- Doses:
- 5 ml/kg
- No. of animals per sex per dose:
- 3 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily (toxic effects, dermal reactions and mortality)
- Necropsy of survivors performed: yes - Key result
- Dose descriptor:
- LD50
- Effect level:
- > 5 mL/kg bw
- Mortality:
- No mortality was observed.
- Clinical signs:
- Erythema and edema were observed
- Body weight:
- No data
- Gross pathology:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS. Therefore, the registered substance is not considered toxic by dermal route.
- Executive summary:
In an acute dermal toxicity study (limit test), three rabbits were given a single dermal application of labdanuml at 5000 mL/kg bw. Animals were observed for mortality and clinical signs for 14 days.
No mortality was observed. Edema and Erythema were observed.
In this study, the dermal LD50 of the test item was higher than 5000 mL/kg bw in rats.
Under the experimental conditions of this study, the test item is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS. Therefore, the registered substance is not considered toxic by dermal route.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
Acute toxicity: oral
In an acute oral toxicity study performed according to the OECD Guideline 423 and in compliance with GLP, a single dose of 2000 mg/kg bw of the test substance solubilized in olive oil and heated during 5 minutes at ca. 50°C was given by oral gavage to a group of 6 female Sprague Dawley rats. Animals were then observed for mortality, clinical signs and body weight changes for 14 days, and were all sacrificed for macroscopic examinations.
No mortality occurred during the study. No clinical signs related to the administration of the test item were observed during the study The body weight evolution of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
Rat Oral LD50 (Female) >2000 mg/kg bw.
Under the test conditions, the oral LD50 of the test substance is >2000 mg/kg bw in rats. In accordance with OECD Guideline 423, the LD50 cut-off of the test substance may be considered to be higher than 5000 mg/kg bw by oral route in the rat.
Acute oral toxicity:
In an acute oral toxicity study performed according to OECD Guideline 420 and in compliance with GLP, groups (5 females/dose) of Wistar (RccHan™:WIST) rats were given a single oral (gavage) dose of test item at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination. Sighting study was conducted at the dose levels of 300 and 2000 mg/kg bw (one female/dose) to determine the dose for main study.
In the sighting study, no mortality or clinical signs were observed at 300 mg/kg bw. The animal showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy. In the main study, no mortality or clinical signs were observed at 2000 mg/kg bw. All animals showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy.
Rat Oral LD50 (females) > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and GHS..
Acute dermal toxicity:
In an acute dermal toxicity study (limit test), three rabbits were given a single dermal application of labdanuml at 5000 mL/kg bw. Animals were observed for mortality and clinical signs for 14 days.
No mortality was observed. Edema and Erythema were observed.
In this study, the dermal LD50 of the test item was higher than 5000 mL/kg bw in rats.
Under the experimental conditions of this study, the test item is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.Therefore, the registered substance is not considered toxic by dermal route.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self classification:
Acute toxicity via Oral route:
Based on the available data the substance is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the Globally Harmonised System of classification and labelling of chemicals (GHS) as the oral LD50 is higher than 5000 mg/kg bw.
Acute toxicity via Dermal route:
Based on the available data the substance is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the Globally Harmonised System of classification and labelling of chemicals (GHS) as the oral LD50 is higher than 5000 mg/kg bw.
Acute toxicity (Inhalation):
No data was available.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)